<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/NCT04413799</url>
  </required_header>
  <id_info>
    <org_study_id>NRC1972020</org_study_id>
    <nct_id>NCT04413799</nct_id>
  </id_info>
  <brief_title>PVB vs Ketamine/Lidocaine in Rib Fracture Patients</brief_title>
  <official_title>Paravertebral Block Versus Simultaneous Ketamine and Lidocaine Infusions for Pain Management in Rib Fracture Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>George Washington University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>George Washington University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rib fractures are a common admission to the trauma service. The mainstay of treatment is pain&#xD;
      control to improve respiratory effort in order to offset the risk of pneumonia and mechanical&#xD;
      ventilation. In addition to standard pain control modalities, the investigator's institution&#xD;
      utilizes paravertebral blocks as well as lidocaine and ketamine infusions for pain control.&#xD;
      The current standard of care for pain control is to begin with acetaminophen, ibuprofen or&#xD;
      celecoxib and opioids with the addition of paravertebral blocks as needed. In certain&#xD;
      situations, a paravertebral block is contraindicated, and pain control is relegated to&#xD;
      lidocaine and ketamine infusion. The use of lidocaine infusion alone and ketamine infusion&#xD;
      alone for pain control has been studied and has been shown to be safe. However, concurrent&#xD;
      use of these two medications to control rib fracture pain is relatively new and the efficacy&#xD;
      compared to paravertebral block is not known. The goal of the study is to show&#xD;
      non-inferiority of simultaneous lidocaine and ketamine infusions versus paravertebral blocks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Traumatic rib fractures are a common pathology in the trauma population. It is estimated that&#xD;
      10% of all trauma patients have rib fractures. The mainstay of treatment of rib fracture is&#xD;
      pain control to allow for good pulmonary hygiene and function. When pain is not controlled,&#xD;
      patients have a higher chance of developing pneumonia, which can lead to respiratory failure&#xD;
      needing mechanical ventilation, eventually increasing patients' morbidity and mortality.&#xD;
      These sequelae are most common in the elderly population. Multiple studies has shown that&#xD;
      elderly patients with rib fractures have worse outcomes compared to younger patients with the&#xD;
      same fracture pattern.&#xD;
&#xD;
      Pain control for acute rib fracture is achieved using multimodal analgesia to reduce the&#xD;
      usage of opioids. Multimodal analgesia means using 2 or more drugs that act by different&#xD;
      mechanism to provide pain control. The benefit of multimodal strategy is twofold; decrease&#xD;
      the use of opioids and the associated side effects (eg. depressed respiratory drive,&#xD;
      delirium, alteration of mental status) and better pain control. However, even with multimodal&#xD;
      analgesia, pain control for acute traumatic rib fractures can be challenging. There are&#xD;
      currently no validated management guidelines for traumatic rib fracture pain control and the&#xD;
      approach varies by organization. At the investigator's institution, the investigators use a&#xD;
      scheduled regimen of acetaminophen and NSAIDs, along with opioid medication as needed for&#xD;
      pain. If this regimen is insufficient, other adjuncts such as paravertebral blocks (PVBs) and&#xD;
      intravenous ketamine and lidocaine infusions are utilized. There are currently limited data&#xD;
      on the combined use of ketamine and lidocaine infusions for traumatic rib fractures and it is&#xD;
      unclear if the combination is non-inferior to PVBs in this patient population.&#xD;
&#xD;
      Continuous PVB infusion is a well-documented approach for pain control in traumatic rib&#xD;
      fractures. But, there are occasionally prohibitive situations that contraindicate PVBs, such&#xD;
      as vertebral fractures. Ketamine and lidocaine infusions are an attractive alternative in&#xD;
      these situations, but the data regarding efficacy are lacking. Low dose ketamine infusion is&#xD;
      a new addition to the pain control algorithm for trauma patients. Given that this is a novel&#xD;
      approach, studies evaluating efficacy are sparse. There have been two randomized controlled&#xD;
      trials utilizing low dose ketamine in trauma patients and elderly patients with rib&#xD;
      fractures. Both were unable to show a decrease in opioid use; however, the authors were able&#xD;
      to show a decrease in pain scores in patients with injury severity score (ISS) &gt;15 in both&#xD;
      studies. Another study of ketamine infusion in traumatic rib fracture patients admitted to&#xD;
      the ICU showed an improvement in numeric pain scores (NPS) and decreased opioids requirements&#xD;
      but, as in the previous studies, the ISS of these patients was very high (40) in both the&#xD;
      ketamine and non-ketamine groups making generalization to the overall trauma population&#xD;
      difficult.&#xD;
&#xD;
      Lidocaine has also been extensively studied as a local anesthetic and more recently has&#xD;
      become popular as an infusion for systemic pain control. A recent review article compared 16&#xD;
      randomized control trials of lidocaine infusion on postoperative patients and showed that&#xD;
      patients undergoing abdominal surgery had significant decreases in postoperative opioid&#xD;
      consumption and improved pain scores. There has been some research into lidocaine infusions&#xD;
      in burn patients showing that it can decrease opioid usage by 25%, but the cohort was small&#xD;
      and there was no difference in reported pain scores. These data are intriguing but the&#xD;
      applicability to trauma patients is questionable. Unfortunately, there has been no study to&#xD;
      assess lidocaine infusions in patients with traumatic rib fractures. The investigators&#xD;
      believe that there is a role for simultaneous lidocaine and ketamine infusions in traumatic&#xD;
      rib fracture patients that may provide better pain control than each one used as a single&#xD;
      infusion. The investigators propose a prospective, randomized open label clinical trial&#xD;
      evaluating continuous infusion of ropivacaine via PVBs against simultaneous ketamine and&#xD;
      lidocaine infusions. The instigators hypothesize that simultaneous lidocaine and ketamine&#xD;
      infusions is non inferior to PVBs in traumatic rib fracture patients. The results of this&#xD;
      study could help guide pain control strategies in this patient population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">May 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <phase>Early Phase 1</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Numeric Pain Score (NPS)</measure>
    <time_frame>throughout patients' hospitalization time, an average of 1 week</time_frame>
    <description>Numeric pain score is a scale of 1- 10 to ascertain patient's subjective pain severity. Patients will be asked their NPS daily.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral Morphine Equivalence (OME)</measure>
    <time_frame>throughout patients' hospitalization time, an average of 1 week</time_frame>
    <description>Oral morphine equivalence is used to standardized the amount of opioid patient is using regardless the type of opioid that the patient is prescribed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital Length of Stay (LOS)</measure>
    <time_frame>captured after patient is discharged, an average of 1 week</time_frame>
    <description>The hospital length of stay will be captured after patient is discharged from the hospital.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU Length of Stay (ICU LOS)</measure>
    <time_frame>captured after patient is discharged, an average of 1 week</time_frame>
    <description>The ICU length of stay will be captured after patient is discharged from the hospital.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of pneumonia</measure>
    <time_frame>throughout patients' hospitalization time, an average of 1 week</time_frame>
    <description>The diagnosis of pneumonia is captured when it is diagnosed by the primary team taking care of the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ventilator days</measure>
    <time_frame>throughout patients' hospitalization time, an average of 1 week</time_frame>
    <description>We will obtain the number of days patient is on the ventilator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>disposition upon discharge</measure>
    <time_frame>captured after patient is discharged, an average of 1 week</time_frame>
    <description>Patient's disposition after discharge will be recorded. Disposition of patient will be recorded as home, long term acute facility, skilled nursing facility or acute rehab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>in-hospital mortality</measure>
    <time_frame>captured after patient is discharged, an average of 1 week</time_frame>
    <description>Patient's death will be recorded if it happen before discharge</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">170</enrollment>
  <condition>Rib Fractures</condition>
  <condition>Rib Trauma</condition>
  <condition>Rib Fracture Multiple</condition>
  <condition>Pain, Acute</condition>
  <arm_group>
    <arm_group_label>lidocaine/ ketamine infusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lidocaine/ ketamine infusion will be monitored and titrated as necessary by Anesthesiologist led Acute Pain Service.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>paravertebral block with ropivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Paravertebral block catheter will be placed by Anesthesiology led Acute Pain Service. Once the catheter is inserted, a ropivacaine bolus and infused with ropivacaine, monitored and titrated as necessary by Anesthesiologist led Acute Pain Service.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>lidocaine, ketamine intravenous infusion</intervention_name>
    <description>Patients will be started with our standard analgesia regiment which is standing oral acetaminophen 1000mg every 8 hours, ibuprofen 600mg every 6 hours or celecoxib 200mg every 12 hours, and narcotics as needed. All patients who failed the standard analgesia regimen will be approached for the study. Failure of standard analgesia regimen will be determined by respirations &gt;20 minute, tidal volume ≤50% of predicted, numeric pain score ≥ 5, and a poor cough as determined by the trauma team.&#xD;
Once the consent is obtained, the patients will be randomized to either PVB (control) or lidocaine/ketamine (study) groups. If the patient is randomized to lidocaine/ketamine group, the anesthesiologist led Acute Pain Service (APS) will prescribe lidocaine/ ketamine infusion, which will be monitored and titrated as necessary by APS. Standard analgesia will be continued on both study groups</description>
    <arm_group_label>lidocaine/ ketamine infusion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>paravertebral block with ropivicaine</intervention_name>
    <description>Patients will be started with our standard analgesia regiment which is standing oral acetaminophen 1000mg every 8 hours, ibuprofen 600mg every 6 hours or celecoxib 200mg every 12 hours, and narcotics as needed. All patients who failed the standard analgesia regimen will be approached for the study. Failure of standard analgesia regimen will be determined by respirations &gt;20 minute, tidal volume ≤50% of predicted, numeric pain score ≥ 5, and a poor cough as determined by the trauma team.&#xD;
Once the consent is obtained, the patients will be randomized to either PVB (control) or lidocaine/ketamine (study) groups. If the patient is randomized to PVB, the anesthesiologist led Acute Pain Service (APS) will place a paravertebral block catheter. Ropivacaine infusion will be started, monitored and titrated as necessary by APS. Standard analgesia will be continued on both study groups</description>
    <arm_group_label>paravertebral block with ropivacaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18-80 with rib fracture requiring hospitalization&#xD;
&#xD;
          -  Failure of standard pain regimen as determined by RR &gt; 20, TV &lt; or equal to 50%&#xD;
             predicted, NPS &gt; or equal to 5, Poor cough&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age less than 18 years&#xD;
&#xD;
          -  greater than 80 years&#xD;
&#xD;
          -  GCS less than or equal to 13&#xD;
&#xD;
          -  intubated at admission&#xD;
&#xD;
          -  prior or anticipated exploratory laparotomy during this admission&#xD;
&#xD;
          -  prior or expected thoracotomy during this admission&#xD;
&#xD;
          -  prior or expected emergent craniotomy during this admission&#xD;
&#xD;
          -  spinal cord injury&#xD;
&#xD;
          -  pelvic injury that has required or will require operative intervention&#xD;
&#xD;
          -  inability to accomplish activities of daily living independently&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  incarceration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Susan Kartiko, MD PhD</last_name>
    <phone>7136776219</phone>
    <email>skartiko@mfa.gwu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tremaine Brock</last_name>
    <email>tbrock@mfa.gwu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The George Washington University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Susan Kartiko, MD PhD</last_name>
      <phone>713-677-6219</phone>
      <email>skartiko@mfa.gwu.edu</email>
    </contact>
    <contact_backup>
      <last_name>Paul Dangerfield, MD</last_name>
      <email>pdangerfield@mfa.gwu.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ziegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma. 1994 Dec;37(6):975-9. doi: 10.1097/00005373-199412000-00018.</citation>
    <PMID>7996614</PMID>
  </reference>
  <reference>
    <citation>Bulger EM, Edwards T, Klotz P, Jurkovich GJ. Epidural analgesia improves outcome after multiple rib fractures. Surgery. 2004 Aug;136(2):426-30. doi: 10.1016/j.surg.2004.05.019.</citation>
    <PMID>15300210</PMID>
  </reference>
  <reference>
    <citation>Bulger EM, Arneson MA, Mock CN, Jurkovich GJ. Rib fractures in the elderly. J Trauma. 2000 Jun;48(6):1040-6; discussion 1046-7. doi: 10.1097/00005373-200006000-00007.</citation>
    <PMID>10866248</PMID>
  </reference>
  <reference>
    <citation>Holcomb JB, McMullin NR, Kozar RA, Lygas MH, Moore FA. Morbidity from rib fractures increases after age 45. J Am Coll Surg. 2003 Apr;196(4):549-55. doi: 10.1016/S1072-7515(02)01894-X.</citation>
    <PMID>12691929</PMID>
  </reference>
  <reference>
    <citation>Karmakar MK, Critchley LA, Ho AM, Gin T, Lee TW, Yim AP. Continuous thoracic paravertebral infusion of bupivacaine for pain management in patients with multiple fractured ribs. Chest. 2003 Feb;123(2):424-31. doi: 10.1378/chest.123.2.424.</citation>
    <PMID>12576361</PMID>
  </reference>
  <reference>
    <citation>Luyet C, Herrmann G, Ross S, Vogt A, Greif R, Moriggl B, Eichenberger U. Ultrasound-guided thoracic paravertebral puncture and placement of catheters in human cadavers: where do catheters go? Br J Anaesth. 2011 Feb;106(2):246-54. doi: 10.1093/bja/aeq309. Epub 2010 Nov 25.</citation>
    <PMID>21112880</PMID>
  </reference>
  <reference>
    <citation>Womack J, Pearson JD, Walker IA, Stephens NM, Goodman BA. Safety, complications and clinical outcome after ultrasound-guided paravertebral catheter insertion for rib fracture analgesia: a single-centre retrospective observational study. Anaesthesia. 2019 May;74(5):594-601. doi: 10.1111/anae.14580. Epub 2019 Jan 27.</citation>
    <PMID>30687939</PMID>
  </reference>
  <reference>
    <citation>Malekpour M, Hashmi A, Dove J, Torres D, Wild J. Analgesic Choice in Management of Rib Fractures: Paravertebral Block or Epidural Analgesia? Anesth Analg. 2017 Jun;124(6):1906-1911. doi: 10.1213/ANE.0000000000002113.</citation>
    <PMID>28525509</PMID>
  </reference>
  <reference>
    <citation>Carver TW, Kugler NW, Juul J, Peppard WJ, Drescher KM, Somberg LB, Szabo A, Yin Z, Paul JS. Ketamine infusion for pain control in adult patients with multiple rib fractures: Results of a randomized control trial. J Trauma Acute Care Surg. 2019 Feb;86(2):181-188. doi: 10.1097/TA.0000000000002103.</citation>
    <PMID>30376537</PMID>
  </reference>
  <reference>
    <citation>Kugler NW, Carver TW, Juul J, Peppard WJ, Boyle K, Drescher KM, Szabo A, Rein L, Somberg LB, Paul JS. Ketamine infusion for pain control in elderly patients with multiple rib fractures: Results of a randomized controlled trial. J Trauma Acute Care Surg. 2019 Nov;87(5):1181-1188. doi: 10.1097/TA.0000000000002479.</citation>
    <PMID>31425468</PMID>
  </reference>
  <reference>
    <citation>Walters MK, Farhat J, Bischoff J, Foss M, Evans C. Ketamine as an Analgesic Adjuvant in Adult Trauma Intensive Care Unit Patients With Rib Fracture. Ann Pharmacother. 2018 Sep;52(9):849-854. doi: 10.1177/1060028018768451. Epub 2018 Apr 2.</citation>
    <PMID>29607659</PMID>
  </reference>
  <reference>
    <citation>de Rocquigny G, Dubecq C, Martinez T, Peffer J, Cauet A, Travers S, Pasquier P. Use of ketamine for prehospital pain control on the battlefield: A systematic review. J Trauma Acute Care Surg. 2020 Jan;88(1):180-185. doi: 10.1097/TA.0000000000002522.</citation>
    <PMID>31688832</PMID>
  </reference>
  <reference>
    <citation>BARTLETT EE, HUTSERANI O. Xylocaine for the relief of postoperative pain. Anesth Analg. 1961 May-Jun;40:296-304. No abstract available.</citation>
    <PMID>14448503</PMID>
  </reference>
  <reference>
    <citation>Kim YC, Castaneda AM, Lee CS, Jin HS, Park KS, Moon JY. Efficacy and Safety of Lidocaine Infusion Treatment for Neuropathic Pain: A Randomized, Double-Blind, and Placebo-Controlled Study. Reg Anesth Pain Med. 2018 May;43(4):415-424. doi: 10.1097/AAP.0000000000000741.</citation>
    <PMID>29381569</PMID>
  </reference>
  <reference>
    <citation>McCarthy GC, Megalla SA, Habib AS. Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials. Drugs. 2010 Jun 18;70(9):1149-63. doi: 10.2165/10898560-000000000-00000.</citation>
    <PMID>20518581</PMID>
  </reference>
  <reference>
    <citation>Abdelrahman I, Steinvall I, Elmasry M, Sjoberg F. Lidocaine infusion has a 25% opioid-sparing effect on background pain after burns: A prospective, randomised, double-blind, controlled trial. Burns. 2020 Mar;46(2):465-471. doi: 10.1016/j.burns.2019.08.010. Epub 2019 Sep 5.</citation>
    <PMID>31493952</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>January 3, 2023</last_update_submitted>
  <last_update_submitted_qc>January 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>George Washington University</investigator_affiliation>
    <investigator_full_name>Susan Kartiko</investigator_full_name>
    <investigator_title>Assistant Professor of Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Pain</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Rib Fractures</mesh_term>
    <mesh_term>Fractures, Multiple</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Ketamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will not be shared with other researchers.</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/NCT04413799
org study id: NRC1972020
nct id: NCT04413799
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Rib fractures are a common admission to the trauma service. The mainstay of treatment is pain
      control to improve respiratory effort in order to offset the risk of pneumonia and mechanical
      ventilation. In addition to standard pain control modalities, the investigator's institution
      utilizes paravertebral blocks as well as lidocaine and ketamine infusions for pain control.
      The current standard of care for pain control is to begin with acetaminophen, ibuprofen or
      celecoxib and opioids with the addition of paravertebral blocks as needed. In certain
      situations, a paravertebral block is contraindicated, and pain control is relegated to
      lidocaine and ketamine infusion. The use of lidocaine infusion alone and ketamine infusion
      alone for pain control has been studied and has been shown to be safe. However, concurrent
      use of these two medications to control rib fracture pain is relatively new and the efficacy
      compared to paravertebral block is not known. The goal of the study is to show
      non-inferiority of simultaneous lidocaine and ketamine infusions versus paravertebral blocks.
Traumatic rib fractures are a common pathology in the trauma population. It is estimated that
      10% of all trauma patients have rib fractures. The mainstay of treatment of rib fracture is
      pain control to allow for good pulmonary hygiene and function. When pain is not controlled,
      patients have a higher chance of developing pneumonia, which can lead to respiratory failure
      needing mechanical ventilation, eventually increasing patients' morbidity and mortality.
      These sequelae are most common in the elderly population. Multiple studies has shown that
      elderly patients with rib fractures have worse outcomes compared to younger patients with the
      same fracture pattern.

      Pain control for acute rib fracture is achieved using multimodal analgesia to reduce the
      usage of opioids. Multimodal analgesia means using 2 or more drugs that act by different
      mechanism to provide pain control. The benefit of multimodal strategy is twofold; decrease
      the use of opioids and the associated side effects (eg. depressed respiratory drive,
      delirium, alteration of mental status) and better pain control. However, even with multimodal
      analgesia, pain control for acute traumatic rib fractures can be challenging. There are
      currently no validated management guidelines for traumatic rib fracture pain control and the
      approach varies by organization. At the investigator's institution, the investigators use a
      scheduled regimen of acetaminophen and NSAIDs, along with opioid medication as needed for
      pain. If this regimen is insufficient, other adjuncts such as paravertebral blocks (PVBs) and
      intravenous ketamine and lidocaine infusions are utilized. There are currently limited data
      on the combined use of ketamine and lidocaine infusions for traumatic rib fractures and it is
      unclear if the combination is non-inferior to PVBs in this patient population.

      Continuous PVB infusion is a well-documented approach for pain control in traumatic rib
      fractures. But, there are occasionally prohibitive situations that contraindicate PVBs, such
      as vertebral fractures. Ketamine and lidocaine infusions are an attractive alternative in
      these situations, but the data regarding efficacy are lacking. Low dose ketamine infusion is
      a new addition to the pain control algorithm for trauma patients. Given that this is a novel
      approach, studies evaluating efficacy are sparse. There have been two randomized controlled
      trials utilizing low dose ketamine in trauma patients and elderly patients with rib
      fractures. Both were unable to show a decrease in opioid use; however, the authors were able
      to show a decrease in pain scores in patients with injury severity score (ISS) >15 in both
      studies. Another study of ketamine infusion in traumatic rib fracture patients admitted to
      the ICU showed an improvement in numeric pain scores (NPS) and decreased opioids requirements
      but, as in the previous studies, the ISS of these patients was very high (40) in both the
      ketamine and non-ketamine groups making generalization to the overall trauma population
      difficult.

      Lidocaine has also been extensively studied as a local anesthetic and more recently has
      become popular as an infusion for systemic pain control. A recent review article compared 16
      randomized control trials of lidocaine infusion on postoperative patients and showed that
      patients undergoing abdominal surgery had significant decreases in postoperative opioid
      consumption and improved pain scores. There has been some research into lidocaine infusions
      in burn patients showing that it can decrease opioid usage by 25%, but the cohort was small
      and there was no difference in reported pain scores. These data are intriguing but the
      applicability to trauma patients is questionable. Unfortunately, there has been no study to
      assess lidocaine infusions in patients with traumatic rib fractures. The investigators
      believe that there is a role for simultaneous lidocaine and ketamine infusions in traumatic
      rib fracture patients that may provide better pain control than each one used as a single
      infusion. The investigators propose a prospective, randomized open label clinical trial
      evaluating continuous infusion of ropivacaine via PVBs against simultaneous ketamine and
      lidocaine infusions. The instigators hypothesize that simultaneous lidocaine and ketamine
      infusions is non inferior to PVBs in traumatic rib fracture patients. The results of this
      study could help guide pain control strategies in this patient population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Numeric Pain Score (NPS)
time frame: throughout patients' hospitalization time, an average of 1 week
description: Numeric pain score is a scale of 1- 10 to ascertain patient's subjective pain severity. Patients will be asked their NPS daily.
measure: Oral Morphine Equivalence (OME)
time frame: throughout patients' hospitalization time, an average of 1 week
description: Oral morphine equivalence is used to standardized the amount of opioid patient is using regardless the type of opioid that the patient is prescribed.
measure: Hospital Length of Stay (LOS)
time frame: captured after patient is discharged, an average of 1 week
description: The hospital length of stay will be captured after patient is discharged from the hospital.
measure: ICU Length of Stay (ICU LOS)
time frame: captured after patient is discharged, an average of 1 week
description: The ICU length of stay will be captured after patient is discharged from the hospital.
measure: incidence of pneumonia
time frame: throughout patients' hospitalization time, an average of 1 week
description: The diagnosis of pneumonia is captured when it is diagnosed by the primary team taking care of the patient.
measure: ventilator days
time frame: throughout patients' hospitalization time, an average of 1 week
description: We will obtain the number of days patient is on the ventilator
measure: disposition upon discharge
time frame: captured after patient is discharged, an average of 1 week
description: Patient's disposition after discharge will be recorded. Disposition of patient will be recorded as home, long term acute facility, skilled nursing facility or acute rehab
measure: in-hospital mortality
time frame: captured after patient is discharged, an average of 1 week
description: Patient's death will be recorded if it happen before discharge
arm group label: lidocaine/ ketamine infusion
arm group type: Active Comparator
description: Lidocaine/ ketamine infusion will be monitored and titrated as necessary by Anesthesiologist led Acute Pain Service.
arm group label: paravertebral block with ropivacaine
arm group type: Active Comparator
description: Paravertebral block catheter will be placed by Anesthesiology led Acute Pain Service. Once the catheter is inserted, a ropivacaine bolus and infused with ropivacaine, monitored and titrated as necessary by Anesthesiologist led Acute Pain Service.
intervention type: Combination Product
intervention name: lidocaine, ketamine intravenous infusion
description: Patients will be started with our standard analgesia regiment which is standing oral acetaminophen 1000mg every 8 hours, ibuprofen 600mg every 6 hours or celecoxib 200mg every 12 hours, and narcotics as needed. All patients who failed the standard analgesia regimen will be approached for the study. Failure of standard analgesia regimen will be determined by respirations >20 minute, tidal volume ≤50% of predicted, numeric pain score ≥ 5, and a poor cough as determined by the trauma team.
Once the consent is obtained, the patients will be randomized to either PVB (control) or lidocaine/ketamine (study) groups. If the patient is randomized to lidocaine/ketamine group, the anesthesiologist led Acute Pain Service (APS) will prescribe lidocaine/ ketamine infusion, which will be monitored and titrated as necessary by APS. Standard analgesia will be continued on both study groups
arm group label: lidocaine/ ketamine infusion
intervention type: Drug
intervention name: paravertebral block with ropivicaine
description: Patients will be started with our standard analgesia regiment which is standing oral acetaminophen 1000mg every 8 hours, ibuprofen 600mg every 6 hours or celecoxib 200mg every 12 hours, and narcotics as needed. All patients who failed the standard analgesia regimen will be approached for the study. Failure of standard analgesia regimen will be determined by respirations >20 minute, tidal volume ≤50% of predicted, numeric pain score ≥ 5, and a poor cough as determined by the trauma team.
Once the consent is obtained, the patients will be randomized to either PVB (control) or lidocaine/ketamine (study) groups. If the patient is randomized to PVB, the anesthesiologist led Acute Pain Service (APS) will place a paravertebral block catheter. Ropivacaine infusion will be started, monitored and titrated as necessary by APS. Standard analgesia will be continued on both study groups
arm group label: paravertebral block with ropivacaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Susan Kartiko, MD PhD
phone: 7136776219
email: skartiko@mfa.gwu.edu
last name: Tremaine Brock
email: tbrock@mfa.gwu.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
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PMID: 7996614
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PMID: 30687939
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PMID: 31493952
responsible party type: Principal Investigator
investigator affiliation: George Washington University
investigator full name: Susan Kartiko
investigator title: Assistant Professor of Surgery
mesh term: Acute Pain
mesh term: Fractures, Bone
mesh term: Rib Fractures
mesh term: Fractures, Multiple
mesh term: Lidocaine
mesh term: Ketamine
sharing ipd: No
ipd description: IPD will not be shared with other researchers.