<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/NCT03034382</url>
  </required_header>
  <id_info>
    <org_study_id>SH1</org_study_id>
    <nct_id>NCT03034382</nct_id>
  </id_info>
  <brief_title>Morphine and/or Nalbuphine as Adjuvants in Ultrasound Guided Interscalene Block: for Shoulder Surgeries</brief_title>
  <official_title>Adjuvants to Ultrasonic Guided Interscalene Block In Arthroscopic Rotator Cuff Repair; Morphine and/or Nalbuphine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <brief_summary>
    <textblock>
      the aim of this study is to evaluate the duration of analgesia when either morphine or&#xD;
      nalbuphine or both are used as adjuvants in sonar guided interscalene brachial plexus block&#xD;
      for arthroscopic rotator cuff repair.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2016</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>Phase 2</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>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the total number of analgesic requests</measure>
    <time_frame>72 hours postoperative followup</time_frame>
    <description>the combination of opioid agonist and mixed agonist-antagonist peripherally prevents the development of early tolerance of the opioid agonist; thus the agonist would maintain the same efficacy and this will be obvious clinically by a reduction in the requests for supplementary analgesia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>duration of analgesia</measure>
    <time_frame>72 hours followup</time_frame>
    <description>duration of analgesia when morphine or nalbuphine or both used in interscalene block using VAS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient satisfaction</measure>
    <time_frame>72 hours followup</time_frame>
    <description>- The patient satisfaction score. Patients were also asked to rate their satisfaction with the analgesia on a scale of 0-10 (0 for total dissatisfaction to 10 for total satisfaction).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The first time to ask for analgesics</measure>
    <time_frame>72 hours followup</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sedation score</measure>
    <time_frame>72 hours followup</time_frame>
    <description>recorded every 4 hours; ranging from alert, drowsy, sleeping but responsive to verbal commands up to unarousable (we consider sedation score 3 or more as clinically significant sedation that mandate close patient observation every hour).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of vomiting attacks</measure>
    <time_frame>72 hours followup</time_frame>
    <description>recorded every 4 hours. A vomiting attack was defined by events of vomiting that occurred in a rapid sequence (&lt;1 minute between events). If vomiting was separated by more than 1 minute; they will be considered to be separate attacks. Retching (the same as vomiting but without expulsion of gastric contents) was considered as vomiting. If the patient experienced vomiting; ondansetron 4 mg IV was given.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>itching</measure>
    <time_frame>72 hours followup</time_frame>
    <description>Itching is assessed using an ordinal scale (0 = no itch, 1 = mild, 2 = moderate, 3 = severe).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Rotator Cuff Tear</condition>
  <arm_group>
    <arm_group_label>Morphine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 mg morphine in 5ml volume injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nalbuphine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 mg nalbuphine in 5ml volume injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Morphine and Nalbuphine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 mg morphine and 5 mg nalbuphine in 5 ml volume are injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000.&#xD;
combination of 5 mg morphine and 5 mg nalbuphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bupivacaine 0.5%</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>10 ml of lidocaine 1% and epinephrine 1:400,000 and 5 ml of Bupivacaine 0.5% in interscalene block.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Morphine</intervention_name>
    <description>5 mg morphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block</description>
    <arm_group_label>Morphine</arm_group_label>
    <arm_group_label>Morphine and Nalbuphine</arm_group_label>
    <other_name>morphine sulphate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nalbuphine</intervention_name>
    <description>5 mg nalbuphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block</description>
    <arm_group_label>Morphine and Nalbuphine</arm_group_label>
    <arm_group_label>Nalbuphine</arm_group_label>
    <other_name>nubain</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine 0.5%</intervention_name>
    <description>10 ml of 1% lidocaine +1:400,000 epinephrine and 5 ml of bupivacaine 0.5% injected perineurally in interscalene block</description>
    <arm_group_label>Bupivacaine 0.5%</arm_group_label>
    <other_name>Marcaine HCL</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine Hydrochloride 1% and epinephrine 1:400,000</intervention_name>
    <description>10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block</description>
    <arm_group_label>Bupivacaine 0.5%</arm_group_label>
    <arm_group_label>Morphine</arm_group_label>
    <arm_group_label>Morphine and Nalbuphine</arm_group_label>
    <arm_group_label>Nalbuphine</arm_group_label>
    <other_name>lidocaine HCL and Adrenaline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for arthroscopic repair of rotator cuff muscle tear of the&#xD;
             shoulder.&#xD;
&#xD;
          -  ASA physical status I - Ш.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infection at the site of injection.&#xD;
&#xD;
          -  Coagulopathy or other bleeding diathesis.&#xD;
&#xD;
          -  Known allergy to drugs in the study&#xD;
&#xD;
          -  Preexisting neurologic deficits in the area to be blocked.&#xD;
&#xD;
          -  Inability to communicate with the investigator and the hospital staff.&#xD;
&#xD;
          -  History of chronic opioid use.&#xD;
&#xD;
          -  Morbid obesity BMI&gt;40.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahmoud A Aly, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut University Hospitals</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kawser H Mohammed, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut University Hospitals</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ayman A Mamdouh, Ass Prof</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University Hospitals</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shimaa A Husien, Msc</last_name>
    <phone>01002953253</phone>
    <phone_ext>002</phone_ext>
    <email>shimo.9feb@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assiut University Hospitals</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ayman A Mamdouh, AssProf</last_name>
      <phone>01066066001</phone>
      <phone_ext>002</phone_ext>
      <email>aymanosman2000@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>May 19, 2017</last_update_submitted>
  <last_update_submitted_qc>May 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Shimaa Abbas Hassan</investigator_full_name>
    <investigator_title>Primary investigator</investigator_title>
  </responsible_party>
  <keyword>morphine</keyword>
  <keyword>nalbuphine</keyword>
  <keyword>arthroscopic rotator cuff repair</keyword>
  <keyword>ultrasound guided interscalene block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Morphine</mesh_term>
    <mesh_term>Nalbuphine</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03034382
org study id: SH1
nct id: NCT03034382
lead sponsor: 
the aim of this study is to evaluate the duration of analgesia when either morphine or
      nalbuphine or both are used as adjuvants in sonar guided interscalene brachial plexus block
      for arthroscopic rotator cuff repair.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: the total number of analgesic requests
time frame: 72 hours postoperative followup
description: the combination of opioid agonist and mixed agonist-antagonist peripherally prevents the development of early tolerance of the opioid agonist; thus the agonist would maintain the same efficacy and this will be obvious clinically by a reduction in the requests for supplementary analgesia.
measure: duration of analgesia
time frame: 72 hours followup
description: duration of analgesia when morphine or nalbuphine or both used in interscalene block using VAS.
measure: patient satisfaction
time frame: 72 hours followup
description: - The patient satisfaction score. Patients were also asked to rate their satisfaction with the analgesia on a scale of 0-10 (0 for total dissatisfaction to 10 for total satisfaction).
measure: The first time to ask for analgesics
time frame: 72 hours followup
measure: sedation score
time frame: 72 hours followup
description: recorded every 4 hours; ranging from alert, drowsy, sleeping but responsive to verbal commands up to unarousable (we consider sedation score 3 or more as clinically significant sedation that mandate close patient observation every hour).
measure: number of vomiting attacks
time frame: 72 hours followup
description: recorded every 4 hours. A vomiting attack was defined by events of vomiting that occurred in a rapid sequence (<1 minute between events). If vomiting was separated by more than 1 minute; they will be considered to be separate attacks. Retching (the same as vomiting but without expulsion of gastric contents) was considered as vomiting. If the patient experienced vomiting; ondansetron 4 mg IV was given.
measure: itching
time frame: 72 hours followup
description: Itching is assessed using an ordinal scale (0 = no itch, 1 = mild, 2 = moderate, 3 = severe).
arm group label: Morphine
arm group type: Experimental
description: 5 mg morphine in 5ml volume injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000.
arm group label: Nalbuphine
arm group type: Experimental
description: 5 mg nalbuphine in 5ml volume injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000.
arm group label: Morphine and Nalbuphine
arm group type: Experimental
description: 5 mg morphine and 5 mg nalbuphine in 5 ml volume are injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000.
combination of 5 mg morphine and 5 mg nalbuphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block
arm group label: Bupivacaine 0.5%
arm group type: Placebo Comparator
description: 10 ml of lidocaine 1% and epinephrine 1:400,000 and 5 ml of Bupivacaine 0.5% in interscalene block.
intervention type: Drug
intervention name: Morphine
description: 5 mg morphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block
arm group label: Morphine
arm group label: Morphine and Nalbuphine
other name: morphine sulphate
intervention type: Drug
intervention name: Nalbuphine
description: 5 mg nalbuphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block
arm group label: Morphine and Nalbuphine
arm group label: Nalbuphine
other name: nubain
intervention type: Drug
intervention name: Bupivacaine 0.5%
description: 10 ml of 1% lidocaine +1:400,000 epinephrine and 5 ml of bupivacaine 0.5% injected perineurally in interscalene block
arm group label: Bupivacaine 0.5%
other name: Marcaine HCL
intervention type: Drug
intervention name: Lidocaine Hydrochloride 1% and epinephrine 1:400,000
description: 10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block
arm group label: Bupivacaine 0.5%
arm group label: Morphine
arm group label: Morphine and Nalbuphine
arm group label: Nalbuphine
other name: lidocaine HCL and Adrenaline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Mahmoud A Aly, Prof
role: Study Chair
affiliation: Assiut University Hospitals
last name: Kawser H Mohammed, Prof
role: Study Chair
affiliation: Assiut University Hospitals
last name: Ayman A Mamdouh, Ass Prof
role: Study Director
affiliation: Assiut University Hospitals
last name: Shimaa A Husien, Msc
phone: 01002953253
phone ext: 002
email: shimo.9feb@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Shimaa Abbas Hassan
investigator title: Primary investigator
mesh term: Rotator Cuff Injuries
mesh term: Lidocaine
mesh term: Epinephrine
mesh term: Morphine
mesh term: Nalbuphine
mesh term: Bupivacaine
sharing ipd: Undecided