<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03041506</url>
  </required_header>
  <id_info>
    <org_study_id>TASMC-16-IM-0221-CTIL</org_study_id>
    <nct_id>NCT03041506</nct_id>
  </id_info>
  <brief_title>Interscalene Nerve Block vs. Sedation for Shoulder Dislocation Reduction</brief_title>
  <official_title>US Guided Interscalene Block Compared With Sedation for Shoulder Dislocation Reduction in the ER</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Shoulder dislocation is the most common joint dislocation presented to the emergency room&#xD;
      (ER) and reduction by medical team is always needed. Shoulder dislocation and reduction are&#xD;
      often very painful and require some form of sedation, pain relief and muscle relaxation for&#xD;
      reduction maneuvers. Several sedation protocols for reduction maneuver are described in the&#xD;
      literature, and each institution is guided by its own protocol to optimize patient comfort&#xD;
      and safety. At the Tel Aviv Medical Centre (TLVMC) ER sedation with ketamine and midazolam&#xD;
      are the mainstay form of sedation for shoulder dislocation reduction.&#xD;
&#xD;
      Sedation is not without risk, it is time consuming for the medical staff, and need personal&#xD;
      supervision. Sedation under busy ER conditions can cause a burden to the medical team which&#xD;
      can end up in treatment insufficiency and patient safety failure.&#xD;
&#xD;
      Ultrasound (US) guided interscalene block (ISCB) for shoulder surgery was found to be an&#xD;
      effective method for perioperative analgesia. However, there is limited data on performance&#xD;
      of US guided ISCB for shoulder dislocation reduction and its comparison to other analgesic&#xD;
      modalities Both techniques (block and sedation) for shoulder dislocation procedure are being&#xD;
      performed for two years at the TLVMC, however no study was done to evaluate these two&#xD;
      analgesic modalities.&#xD;
&#xD;
      The current study compares sedation vs. US guided ISCB for the treatment of shoulder&#xD;
      dislocation in the ER at the TLVMC.&#xD;
&#xD;
      Study objective:&#xD;
&#xD;
      Comparison of two common analgesic methods, Sedation vs. US guided ISCB, for shoulder&#xD;
      dislocation reduction in our institution.&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      This is a prospective, randomized, interventional, open-label study with two arms- Sedation&#xD;
      group and US guided ISCB group. The sedation will be conducted by the orthopedic surgeon who&#xD;
      is certified to perform sedation and the US guided ISCB will be conducted by a certified&#xD;
      anesthesiologist.&#xD;
&#xD;
      Primary outcome:&#xD;
&#xD;
      Time frame measured from the beginning of reduction procedure until readiness for dismissal&#xD;
      from the ER according to the physician decision.&#xD;
&#xD;
      Secondary outcomes [short list]:&#xD;
&#xD;
      Visual Analogue Score (VAS), patient satisfaction, complications, US guided ISCB and sedation&#xD;
      failure rate, overall reduction success rate, readmission rate to the ER, daily activity&#xD;
      level measured by Quick DASH (Disabilities of Arm, Shoulder and Hand) outcome measure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Shoulder dislocation is the most prevalent dislocation with a frequency of 0.5%-1.7% among&#xD;
      the population, which requires reduction by medical staff in the emergency room (ER).&#xD;
      Reduction procedure is often painful and require some level of sedation, analgesia, and&#xD;
      muscle relaxation for its completeness. Several sedation protocols for reduction maneuver are&#xD;
      described in the literature, and each institution is guided by its own protocol to optimize&#xD;
      patient comfort and safety.&#xD;
&#xD;
      The literature describes multiple sedative agents such as Propofol, Etomidate, Midazolam,&#xD;
      Fentanyl, etc. In the emergency department (ED) at Tel Aviv Medical Center (TLVMC), the&#xD;
      sedation protocol contains Midazolam and Ketamine as the main sedative and analgesic agents.&#xD;
&#xD;
      Sedation is not without a risk. Known complications are respiratory depression, aspiration,&#xD;
      and hemodynamic instability. These complications seem to be more prevalent in patients with&#xD;
      decreased cardio-respiratory reserves, such as elderly, morbid obese, obstructive sleep apnea&#xD;
      (OSA), chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF)&#xD;
      patients.&#xD;
&#xD;
      In addition, sedation requires resources such a facility occupied with equipment for&#xD;
      monitoring vitals, oxygen supply source, capnography and human resources including medical&#xD;
      staff certified to provide sedation and handle any possible complication and nursing staff&#xD;
      supervising the patient throughout the procedure from admission until release home from the&#xD;
      ER.&#xD;
&#xD;
      The ED at the TLVMC is very active and busy throughout the day. Sedation under such condition&#xD;
      create a real challenge for the medical team. This is translated into shortage in manpower&#xD;
      and equipment availability and time needed to care for each patient. Such an atmosphere&#xD;
      create huge burden on the medical team which can end up in treatment insufficiency and&#xD;
      patient safety failure.&#xD;
&#xD;
      Recently, several new publications were published regarding the implementation of peripheral&#xD;
      nerve block (PNB) under US guidance for analgesia and painful orthopedic procedure in the ER.&#xD;
      Implementation of PNB for pain management in orthopedic procedures in the ER might constitute&#xD;
      theoretical advantages over sedation.&#xD;
&#xD;
      Interscalene block (ISCB) is a very effective tool being used during shoulder surgery.&#xD;
      However, there is limited data on performance of US guided ISCB for shoulder dislocation&#xD;
      reduction and it's comparison with other analgesic modalities.Only one study to date compared&#xD;
      sedation vs. US guided ISCB for shoulder dislocation reduction procedure in the ER. This&#xD;
      study showed that patients who received ISCB had a shorter length of stay in the ER and&#xD;
      required less supervision and medical intervention from the medical team.&#xD;
&#xD;
      Both US guided ISCB and sedation for shoulder dislocation procedure are being performed for a&#xD;
      while at TLVMC. However no study was done to evaluate them and determine if one of the&#xD;
      analgesic modality have any advantages over the other.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      Comparison of two common analgesic methods, US guided ISCB vs.sedation, for shoulder&#xD;
      dislocation reduction in the ER at the TLVMC.&#xD;
&#xD;
      Methods and Materials&#xD;
&#xD;
      Study Design:&#xD;
&#xD;
      This is a prospective, randomized, interventional non-blinded study with two arms- US guided&#xD;
      ISCB group and Sedation group.&#xD;
&#xD;
      The sedation will be conducted by an orthopedic physician certified to perform sedation and&#xD;
      the US guided ISCB will be conducted by an anesthesiologist who has at least one year of&#xD;
      experience preforming regional anesthesia using US guidance.&#xD;
&#xD;
      Sample Size:&#xD;
&#xD;
      The study will include 70 subjects - 35 in each group. In order to compensate for dropouts we&#xD;
      will aim for recruitment of 90 subjects.&#xD;
&#xD;
      Statistical Analysis:&#xD;
&#xD;
      Quantitative data with normal distribution will be evaluated using t-test for independent&#xD;
      samples. In case the assumptions for parametric test will not hold true, quantitative data&#xD;
      will be evaluated using an a- parametric Mann-Whitney test. Quantitative variables will be&#xD;
      presented as mean and standard deviation.&#xD;
&#xD;
      Dichotomous data will be evaluated using chi-square test. Fischer exact test will be used&#xD;
      when more than 20% of the expected observations were less than 5 or any expected observation&#xD;
      was less than 2.&#xD;
&#xD;
      Categorical data will be presented as a number of cases and percent. Multivariate logistic&#xD;
      regression analysis will be used for the primary outcome in order to determine independent&#xD;
      risk factors. The data included in the multivariate logistic regression model will have a&#xD;
      clinical significance according to the investigator clinical judgment and data found to have&#xD;
      a Pv&lt;0.1 in the univariate analysis. A Pv of 0.05 will be considered significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 15, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Length of stay measured in minutes from the beginning of shoulder dislocation reduction procedure until the subject is ready for discharge from the ER according to the physician decision</measure>
    <time_frame>Up to 3 hours from shoulder dislocation reduction procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Score (VAS) before the shoulder dislocation reduction procedure</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Score (VAS) when subject is ready for discharge from the ER according to the physician decision</measure>
    <time_frame>When subject is ready for discharge from the ER according to the physician decision, up to 3 hours from shoulder dislocation reduction procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction from shoulder dislocation reduction procedure when subject is ready for discharge from the ER according to the physician decision</measure>
    <time_frame>When subject is ready for discharge from the ER according to the physician decision, up to 3 hours from shoulder dislocation reduction procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effect and complications related to US guided ISCB during shoulder dislocation reduction procedure</measure>
    <time_frame>During shoulder dislocation reduction procedure</time_frame>
    <description>Pneumothorax - clinical symptoms of dyspnea, hypoxemia, tachypnea + radiologic confirmation of pneumothorax&#xD;
Local anesthetic systemic toxicity - clinical symptoms range from tinnitus, metallic taste, seizures, loss of consciousness, cardiac arrhythmias, and cardiac arrest&#xD;
Intrathecal injection - local anesthetics penetrate into the subarachnoid space resulting in high spinal anesthesia&#xD;
Intravascular puncture - blood appear in the syringe&#xD;
Horner syndrome - ptosis, miosis and anhydrosis ipsilateral to the side of the ISCB&#xD;
Hoarseness - voice change&#xD;
Respiratory failure - phrenic nerve blockade with resultant diaphragmatic paresis in the ipsilateral side of the ISCB&#xD;
Neurologic injury - sensory or motor deficit after ISCB</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications related to sedation during shoulder dislocation reduction procedure</measure>
    <time_frame>During shoulder dislocation reduction procedure</time_frame>
    <description>Respiratory complications - aspiration with signs of fluid or food regurgitation respiratory depression and upper airway obstruction&#xD;
Hemodynamic instability - cardiac arrhythmias and hypotension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Failed US guided ISCB rate (preceded by sedation) during shoulder dislocation reduction procedure</measure>
    <time_frame>During shoulder dislocation reduction procedure</time_frame>
    <description>Failed ISCB - no loss of cold sensation over the blocked shoulder and no pain relief after ISCB</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall success rate for shoulder dislocation reduction procedure</measure>
    <time_frame>During shoulder dislocation reduction procedure</time_frame>
    <description>Success full shoulder reduction - confirmed by an X ray study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Easiness of shoulder dislocation reduction procedure assessed by orthopedic physician</measure>
    <time_frame>During shoulder dislocation reduction procedure</time_frame>
    <description>The orthopedic physician will be asked to describe his/her personal difficulty to perform the shoulder dislocation reduction procedure Severity score: 1-Easy; 2-Relatively easy; 3-Moderate; 4-Moderate to severe; 5-Severe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Failed sedation rate (preceded by general anesthesia) during shoulder dislocation reduction procedure</measure>
    <time_frame>During shoulder dislocation reduction procedure</time_frame>
    <description>Failed sedation - patient is uncooperative or in pain not allowing the orthopedic physician to perform reduction procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Score (VAS) 24 hours after readiness for dismissal from ER</measure>
    <time_frame>24 hours after readiness for dismissal</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission to the ER during 24 hours from readiness for dismissal from the ER</measure>
    <time_frame>During 24 hours from readiness for dismissal</time_frame>
    <description>Any reason for patient readmission to the ER</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Limb daily activity level measured by &quot;Quick DASH&quot; score 72 hours from readiness for dismissal from the ER</measure>
    <time_frame>72 hours from readiness for dismissal from the ER</time_frame>
    <description>Quick DASH is a questionnaire that measure upper limb daily activity level</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Shoulder Dislocation</condition>
  <condition>Brachial Plexus Block</condition>
  <arm_group>
    <arm_group_label>Sedation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Analgesia and sedation through IV medication for pain relief will be administered to the patient.&#xD;
Midazolam: up to a maximum dosage of 0.1 mg/kg (bolus of 1 mg by titration every 30-60 second).&#xD;
Ketamine: up to maximum dosage of 100 mg IV (bolus of 25 mg by titration every 30-60 seconds).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>US guided ISCB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infiltration of local anesthetic agents around target nerves (C5, C6 nerve roots), US guidance, for shoulder pain relief and muscle relaxation.&#xD;
Lidocaine 2%: 15-20 ml.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>Infiltration of local anesthetic agents around target nerves (C5, C6 nerve roots), US guidance, for shoulder pain relief and muscle relaxation.&#xD;
Lidocaine 2%: 15 -20 ml.</description>
    <arm_group_label>US guided ISCB</arm_group_label>
    <other_name>Xylocaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>US guided ISCB</intervention_name>
    <description>Infiltration of local anesthetic agents around target nerves (C5, C6 nerve roots), US guidance, for shoulder pain relief and muscle relaxation.&#xD;
Lidocaine 2%: 15 -20 ml.</description>
    <arm_group_label>US guided ISCB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam</intervention_name>
    <description>IV administration up to a maximum dosage of 0.1 mg/kg (bolus of 1 mg by titration every 30-60 seconds) for sedation and pain relief.</description>
    <arm_group_label>Sedation</arm_group_label>
    <other_name>Midolam</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>IV administration up to maximum dosage of 100 mg IV (bolus of 25 mg by titration every 30-60 seconds) for sedation and pain relief.</description>
    <arm_group_label>Sedation</arm_group_label>
    <other_name>Ketalar</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Patients (ASA SCORE I-III) without acute cardio-pulmonary decompensation, who arrive to&#xD;
        the ER with shoulder dislocation for reduction maneuver.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unconscious patient&#xD;
&#xD;
          2. Patient refusal/unable to give informed consent&#xD;
&#xD;
          3. Patients with acute cardio-pulmonary decompensation&#xD;
&#xD;
          4. Patients with known allergy to medications which will be included in the study&#xD;
&#xD;
          5. Patients who suffer additional injuries and need to be hospitalized for further&#xD;
             treatment&#xD;
&#xD;
          6. Patients who received narcotic/sedative premedication before the procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Idit Matot, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chair, Division of Anesthesiology &amp; Critical Care &amp; Pain Tel-Aviv Sourasky Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Idit Matot, MD</last_name>
    <phone>97236974758</phone>
    <email>iditm@tlvmc.gov.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Miri Davidovich</last_name>
    <phone>97236974758</phone>
    <email>mirid@tlvmc.gov.il</email>
  </overall_contact_backup>
  <reference>
    <citation>Perron AD, Ingerski MS, Brady WJ, Erling BF, Ullman EA. Acute complications associated with shoulder dislocation at an academic Emergency Department. J Emerg Med. 2003 Feb;24(2):141-5. doi: 10.1016/s0736-4679(02)00717-5.</citation>
    <PMID>12609642</PMID>
  </reference>
  <reference>
    <citation>Orlinsky M, Shon S, Chiang C, Chan L, Carter P. Comparative study of intra-articular lidocaine and intravenous meperidine/diazepam for shoulder dislocations. J Emerg Med. 2002 Apr;22(3):241-5. doi: 10.1016/s0736-4679(01)00475-9.</citation>
    <PMID>11932085</PMID>
  </reference>
  <reference>
    <citation>Matthews DE, Roberts T. Intraarticular lidocaine versus intravenous analgesic for reduction of acute anterior shoulder dislocations. A prospective randomized study. Am J Sports Med. 1995 Jan-Feb;23(1):54-8. doi: 10.1177/036354659502300109.</citation>
    <PMID>7726351</PMID>
  </reference>
  <reference>
    <citation>Burton JH, Bock AJ, Strout TD, Marcolini EG. Etomidate and midazolam for reduction of anterior shoulder dislocation: a randomized, controlled trial. Ann Emerg Med. 2002 Nov;40(5):496-504. doi: 10.1067/mem.2002.126607.</citation>
    <PMID>12399793</PMID>
  </reference>
  <reference>
    <citation>Taylor DM, O'Brien D, Ritchie P, Pasco J, Cameron PA. Propofol versus midazolam/fentanyl for reduction of anterior shoulder dislocation. Acad Emerg Med. 2005 Jan;12(1):13-9. doi: 10.1197/j.aem.2004.08.039.</citation>
    <PMID>15635132</PMID>
  </reference>
  <reference>
    <citation>Roback MG, Wathen JE, Bajaj L, Bothner JP. Adverse events associated with procedural sedation and analgesia in a pediatric emergency department: a comparison of common parenteral drugs. Acad Emerg Med. 2005 Jun;12(6):508-13. doi: 10.1197/j.aem.2004.12.009.</citation>
    <PMID>15930401</PMID>
  </reference>
  <reference>
    <citation>Blaivas M, Lyon M. Ultrasound-guided interscalene block for shoulder dislocation reduction in the ED. Am J Emerg Med. 2006 May;24(3):293-6. doi: 10.1016/j.ajem.2005.10.004.</citation>
    <PMID>16635700</PMID>
  </reference>
  <reference>
    <citation>Beaudoin FL, Nagdev A, Merchant RC, Becker BM. Ultrasound-guided femoral nerve blocks in elderly patients with hip fractures. Am J Emerg Med. 2010 Jan;28(1):76-81. doi: 10.1016/j.ajem.2008.09.015.</citation>
    <PMID>20006206</PMID>
  </reference>
  <reference>
    <citation>Reid N, Stella J, Ryan M, Ragg M. Use of ultrasound to facilitate accurate femoral nerve block in the emergency department. Emerg Med Australas. 2009 Apr;21(2):124-30. doi: 10.1111/j.1742-6723.2009.01163.x.</citation>
    <PMID>19422409</PMID>
  </reference>
  <reference>
    <citation>Abrahams MS, Aziz MF, Fu RF, Horn JL. Ultrasound guidance compared with electrical neurostimulation for peripheral nerve block: a systematic review and meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Mar;102(3):408-17. doi: 10.1093/bja/aen384. Epub 2009 Jan 26.</citation>
    <PMID>19174373</PMID>
  </reference>
  <reference>
    <citation>Neal JM, Barrington MJ, Brull R, Hadzic A, Hebl JR, Horlocker TT, Huntoon MA, Kopp SL, Rathmell JP, Watson JC. The Second ASRA Practice Advisory on Neurologic Complications Associated With Regional Anesthesia and Pain Medicine: Executive Summary 2015. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):401-30. doi: 10.1097/AAP.0000000000000286.</citation>
    <PMID>26288034</PMID>
  </reference>
  <reference>
    <citation>Borgeat A, Ekatodramis G. Anaesthesia for shoulder surgery. Best Pract Res Clin Anaesthesiol. 2002 Jun;16(2):211-25. doi: 10.1053/bean.2002.0234.</citation>
    <PMID>12491553</PMID>
  </reference>
  <reference>
    <citation>Singelyn FJ, Lhotel L, Fabre B. Pain relief after arthroscopic shoulder surgery: a comparison of intraarticular analgesia, suprascapular nerve block, and interscalene brachial plexus block. Anesth Analg. 2004 Aug;99(2):589-92, table of contents. doi: 10.1213/01.ANE.0000125112.83117.49.</citation>
    <PMID>15271745</PMID>
  </reference>
  <reference>
    <citation>Davis JJ, Swenson JD, Greis PE, Burks RT, Tashjian RZ. Interscalene block for postoperative analgesia using only ultrasound guidance: the outcome in 200 patients. J Clin Anesth. 2009 Jun;21(4):272-7. doi: 10.1016/j.jclinane.2008.08.022. Epub 2009 Jun 6.</citation>
    <PMID>19502031</PMID>
  </reference>
  <reference>
    <citation>Liu SS, Zayas VM, Gordon MA, Beathe JC, Maalouf DB, Paroli L, Liguori GA, Ortiz J, Buschiazzo V, Ngeow J, Shetty T, Ya Deau JT. A prospective, randomized, controlled trial comparing ultrasound versus nerve stimulator guidance for interscalene block for ambulatory shoulder surgery for postoperative neurological symptoms. Anesth Analg. 2009 Jul;109(1):265-71. doi: 10.1213/ane.0b013e3181a3272c.</citation>
    <PMID>19535720</PMID>
  </reference>
  <reference>
    <citation>Blaivas M, Adhikari S, Lander L. A prospective comparison of procedural sedation and ultrasound-guided interscalene nerve block for shoulder reduction in the emergency department. Acad Emerg Med. 2011 Sep;18(9):922-7. doi: 10.1111/j.1553-2712.2011.01140.x. Epub 2011 Aug 30.</citation>
    <PMID>21883635</PMID>
  </reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 22, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>February 5, 2017</last_update_submitted>
  <last_update_submitted_qc>February 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Shoulder dislocation reduction</keyword>
  <keyword>Ultrasound guided interscalene block (ISCB)</keyword>
  <keyword>Sedation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Dislocations</mesh_term>
    <mesh_term>Shoulder Dislocation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Midazolam</mesh_term>
    <mesh_term>Ketamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We do not plan to share individual participant data (IPD).</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03041506
org study id: TASMC-16-IM-0221-CTIL
nct id: NCT03041506
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Shoulder dislocation is the most common joint dislocation presented to the emergency room
      (ER) and reduction by medical team is always needed. Shoulder dislocation and reduction are
      often very painful and require some form of sedation, pain relief and muscle relaxation for
      reduction maneuvers. Several sedation protocols for reduction maneuver are described in the
      literature, and each institution is guided by its own protocol to optimize patient comfort
      and safety. At the Tel Aviv Medical Centre (TLVMC) ER sedation with ketamine and midazolam
      are the mainstay form of sedation for shoulder dislocation reduction.

      Sedation is not without risk, it is time consuming for the medical staff, and need personal
      supervision. Sedation under busy ER conditions can cause a burden to the medical team which
      can end up in treatment insufficiency and patient safety failure.

      Ultrasound (US) guided interscalene block (ISCB) for shoulder surgery was found to be an
      effective method for perioperative analgesia. However, there is limited data on performance
      of US guided ISCB for shoulder dislocation reduction and its comparison to other analgesic
      modalities Both techniques (block and sedation) for shoulder dislocation procedure are being
      performed for two years at the TLVMC, however no study was done to evaluate these two
      analgesic modalities.

      The current study compares sedation vs. US guided ISCB for the treatment of shoulder
      dislocation in the ER at the TLVMC.

      Study objective:

      Comparison of two common analgesic methods, Sedation vs. US guided ISCB, for shoulder
      dislocation reduction in our institution.

      Study design:

      This is a prospective, randomized, interventional, open-label study with two arms- Sedation
      group and US guided ISCB group. The sedation will be conducted by the orthopedic surgeon who
      is certified to perform sedation and the US guided ISCB will be conducted by a certified
      anesthesiologist.

      Primary outcome:

      Time frame measured from the beginning of reduction procedure until readiness for dismissal
      from the ER according to the physician decision.

      Secondary outcomes [short list]:

      Visual Analogue Score (VAS), patient satisfaction, complications, US guided ISCB and sedation
      failure rate, overall reduction success rate, readmission rate to the ER, daily activity
      level measured by Quick DASH (Disabilities of Arm, Shoulder and Hand) outcome measure.
Shoulder dislocation is the most prevalent dislocation with a frequency of 0.5%-1.7% among
      the population, which requires reduction by medical staff in the emergency room (ER).
      Reduction procedure is often painful and require some level of sedation, analgesia, and
      muscle relaxation for its completeness. Several sedation protocols for reduction maneuver are
      described in the literature, and each institution is guided by its own protocol to optimize
      patient comfort and safety.

      The literature describes multiple sedative agents such as Propofol, Etomidate, Midazolam,
      Fentanyl, etc. In the emergency department (ED) at Tel Aviv Medical Center (TLVMC), the
      sedation protocol contains Midazolam and Ketamine as the main sedative and analgesic agents.

      Sedation is not without a risk. Known complications are respiratory depression, aspiration,
      and hemodynamic instability. These complications seem to be more prevalent in patients with
      decreased cardio-respiratory reserves, such as elderly, morbid obese, obstructive sleep apnea
      (OSA), chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF)
      patients.

      In addition, sedation requires resources such a facility occupied with equipment for
      monitoring vitals, oxygen supply source, capnography and human resources including medical
      staff certified to provide sedation and handle any possible complication and nursing staff
      supervising the patient throughout the procedure from admission until release home from the
      ER.

      The ED at the TLVMC is very active and busy throughout the day. Sedation under such condition
      create a real challenge for the medical team. This is translated into shortage in manpower
      and equipment availability and time needed to care for each patient. Such an atmosphere
      create huge burden on the medical team which can end up in treatment insufficiency and
      patient safety failure.

      Recently, several new publications were published regarding the implementation of peripheral
      nerve block (PNB) under US guidance for analgesia and painful orthopedic procedure in the ER.
      Implementation of PNB for pain management in orthopedic procedures in the ER might constitute
      theoretical advantages over sedation.

      Interscalene block (ISCB) is a very effective tool being used during shoulder surgery.
      However, there is limited data on performance of US guided ISCB for shoulder dislocation
      reduction and it's comparison with other analgesic modalities.Only one study to date compared
      sedation vs. US guided ISCB for shoulder dislocation reduction procedure in the ER. This
      study showed that patients who received ISCB had a shorter length of stay in the ER and
      required less supervision and medical intervention from the medical team.

      Both US guided ISCB and sedation for shoulder dislocation procedure are being performed for a
      while at TLVMC. However no study was done to evaluate them and determine if one of the
      analgesic modality have any advantages over the other.

      Objectives:

      Comparison of two common analgesic methods, US guided ISCB vs.sedation, for shoulder
      dislocation reduction in the ER at the TLVMC.

      Methods and Materials

      Study Design:

      This is a prospective, randomized, interventional non-blinded study with two arms- US guided
      ISCB group and Sedation group.

      The sedation will be conducted by an orthopedic physician certified to perform sedation and
      the US guided ISCB will be conducted by an anesthesiologist who has at least one year of
      experience preforming regional anesthesia using US guidance.

      Sample Size:

      The study will include 70 subjects - 35 in each group. In order to compensate for dropouts we
      will aim for recruitment of 90 subjects.

      Statistical Analysis:

      Quantitative data with normal distribution will be evaluated using t-test for independent
      samples. In case the assumptions for parametric test will not hold true, quantitative data
      will be evaluated using an a- parametric Mann-Whitney test. Quantitative variables will be
      presented as mean and standard deviation.

      Dichotomous data will be evaluated using chi-square test. Fischer exact test will be used
      when more than 20% of the expected observations were less than 5 or any expected observation
      was less than 2.

      Categorical data will be presented as a number of cases and percent. Multivariate logistic
      regression analysis will be used for the primary outcome in order to determine independent
      risk factors. The data included in the multivariate logistic regression model will have a
      clinical significance according to the investigator clinical judgment and data found to have
      a Pv<0.1 in the univariate analysis. A Pv of 0.05 will be considered significant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Length of stay measured in minutes from the beginning of shoulder dislocation reduction procedure until the subject is ready for discharge from the ER according to the physician decision
time frame: Up to 3 hours from shoulder dislocation reduction procedure
measure: Visual Analogue Score (VAS) before the shoulder dislocation reduction procedure
time frame: Baseline
measure: Visual Analogue Score (VAS) when subject is ready for discharge from the ER according to the physician decision
time frame: When subject is ready for discharge from the ER according to the physician decision, up to 3 hours from shoulder dislocation reduction procedure
measure: Patient satisfaction from shoulder dislocation reduction procedure when subject is ready for discharge from the ER according to the physician decision
time frame: When subject is ready for discharge from the ER according to the physician decision, up to 3 hours from shoulder dislocation reduction procedure
measure: Side effect and complications related to US guided ISCB during shoulder dislocation reduction procedure
time frame: During shoulder dislocation reduction procedure
description: Pneumothorax - clinical symptoms of dyspnea, hypoxemia, tachypnea + radiologic confirmation of pneumothorax
Local anesthetic systemic toxicity - clinical symptoms range from tinnitus, metallic taste, seizures, loss of consciousness, cardiac arrhythmias, and cardiac arrest
Intrathecal injection - local anesthetics penetrate into the subarachnoid space resulting in high spinal anesthesia
Intravascular puncture - blood appear in the syringe
Horner syndrome - ptosis, miosis and anhydrosis ipsilateral to the side of the ISCB
Hoarseness - voice change
Respiratory failure - phrenic nerve blockade with resultant diaphragmatic paresis in the ipsilateral side of the ISCB
Neurologic injury - sensory or motor deficit after ISCB
measure: Complications related to sedation during shoulder dislocation reduction procedure
time frame: During shoulder dislocation reduction procedure
description: Respiratory complications - aspiration with signs of fluid or food regurgitation respiratory depression and upper airway obstruction
Hemodynamic instability - cardiac arrhythmias and hypotension
measure: Failed US guided ISCB rate (preceded by sedation) during shoulder dislocation reduction procedure
time frame: During shoulder dislocation reduction procedure
description: Failed ISCB - no loss of cold sensation over the blocked shoulder and no pain relief after ISCB
measure: Overall success rate for shoulder dislocation reduction procedure
time frame: During shoulder dislocation reduction procedure
description: Success full shoulder reduction - confirmed by an X ray study
measure: Easiness of shoulder dislocation reduction procedure assessed by orthopedic physician
time frame: During shoulder dislocation reduction procedure
description: The orthopedic physician will be asked to describe his/her personal difficulty to perform the shoulder dislocation reduction procedure Severity score: 1-Easy; 2-Relatively easy; 3-Moderate; 4-Moderate to severe; 5-Severe
measure: Failed sedation rate (preceded by general anesthesia) during shoulder dislocation reduction procedure
time frame: During shoulder dislocation reduction procedure
description: Failed sedation - patient is uncooperative or in pain not allowing the orthopedic physician to perform reduction procedure
measure: Visual Analogue Score (VAS) 24 hours after readiness for dismissal from ER
time frame: 24 hours after readiness for dismissal
measure: Readmission to the ER during 24 hours from readiness for dismissal from the ER
time frame: During 24 hours from readiness for dismissal
description: Any reason for patient readmission to the ER
measure: Limb daily activity level measured by "Quick DASH" score 72 hours from readiness for dismissal from the ER
time frame: 72 hours from readiness for dismissal from the ER
description: Quick DASH is a questionnaire that measure upper limb daily activity level
arm group label: Sedation
arm group type: Active Comparator
description: Analgesia and sedation through IV medication for pain relief will be administered to the patient.
Midazolam: up to a maximum dosage of 0.1 mg/kg (bolus of 1 mg by titration every 30-60 second).
Ketamine: up to maximum dosage of 100 mg IV (bolus of 25 mg by titration every 30-60 seconds).
arm group label: US guided ISCB
arm group type: Experimental
description: Infiltration of local anesthetic agents around target nerves (C5, C6 nerve roots), US guidance, for shoulder pain relief and muscle relaxation.
Lidocaine 2%: 15-20 ml.
intervention type: Drug
intervention name: Lidocaine
description: Infiltration of local anesthetic agents around target nerves (C5, C6 nerve roots), US guidance, for shoulder pain relief and muscle relaxation.
Lidocaine 2%: 15 -20 ml.
arm group label: US guided ISCB
other name: Xylocaine
intervention type: Procedure
intervention name: US guided ISCB
description: Infiltration of local anesthetic agents around target nerves (C5, C6 nerve roots), US guidance, for shoulder pain relief and muscle relaxation.
Lidocaine 2%: 15 -20 ml.
arm group label: US guided ISCB
intervention type: Drug
intervention name: Midazolam
description: IV administration up to a maximum dosage of 0.1 mg/kg (bolus of 1 mg by titration every 30-60 seconds) for sedation and pain relief.
arm group label: Sedation
other name: Midolam
intervention type: Drug
intervention name: Ketamine
description: IV administration up to maximum dosage of 100 mg IV (bolus of 25 mg by titration every 30-60 seconds) for sedation and pain relief.
arm group label: Sedation
other name: Ketalar
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Idit Matot, MD
role: Principal Investigator
affiliation: Chair, Division of Anesthesiology & Critical Care & Pain Tel-Aviv Sourasky Medical Center
last name: Idit Matot, MD
phone: 97236974758
email: iditm@tlvmc.gov.il
last name: Miri Davidovich
phone: 97236974758
email: mirid@tlvmc.gov.il
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responsible party type: Sponsor
mesh term: Joint Dislocations
mesh term: Shoulder Dislocation
mesh term: Lidocaine
mesh term: Midazolam
mesh term: Ketamine
sharing ipd: No
ipd description: We do not plan to share individual participant data (IPD).