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PVB vs Ketamine/Lidocaine in Rib Fracture Patients

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ClinicalTrials.gov Identifier: NCT04413799
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Susan Kartiko, George Washington University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rib Fractures Rib Trauma Rib Fracture Multiple Pain, Acute Combination Product: lidocaine, ketamine intravenous infusion Drug: paravertebral block with ropivicaine Early Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Paravertebral Block Versus Simultaneous Ketamine and Lidocaine Infusions for Pain Management in Rib Fracture Patients
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: lidocaine/ ketamine infusion
Lidocaine/ ketamine infusion will be monitored and titrated as necessary by Anesthesiologist led Acute Pain Service.
Combination Product: lidocaine, ketamine intravenous infusion

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


Active Comparator: paravertebral block with ropivacaine
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.
Drug: paravertebral block with ropivicaine

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





Primary Outcome Measures :
  1. Numeric Pain Score (NPS) [ Time Frame: throughout patients' hospitalization time, an average of 1 week ]
    Numeric pain score is a scale of 1- 10 to ascertain patient's subjective pain severity. Patients will be asked their NPS daily.

  2. Oral Morphine Equivalence (OME) [ Time Frame: throughout patients' hospitalization time, an average of 1 week ]
    Oral morphine equivalence is used to standardized the amount of opioid patient is using regardless the type of opioid that the patient is prescribed.


Secondary Outcome Measures :
  1. Hospital Length of Stay (LOS) [ Time Frame: captured after patient is discharged, an average of 1 week ]
    The hospital length of stay will be captured after patient is discharged from the hospital.

  2. ICU Length of Stay (ICU LOS) [ Time Frame: captured after patient is discharged, an average of 1 week ]
    The ICU length of stay will be captured after patient is discharged from the hospital.

  3. incidence of pneumonia [ Time Frame: throughout patients' hospitalization time, an average of 1 week ]
    The diagnosis of pneumonia is captured when it is diagnosed by the primary team taking care of the patient.

  4. ventilator days [ Time Frame: throughout patients' hospitalization time, an average of 1 week ]
    We will obtain the number of days patient is on the ventilator

  5. disposition upon discharge [ Time Frame: captured after patient is discharged, an average of 1 week ]
    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

  6. in-hospital mortality [ Time Frame: captured after patient is discharged, an average of 1 week ]
    Patient's death will be recorded if it happen before discharge



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-80 with rib fracture requiring hospitalization
  • Failure of standard pain regimen as determined by RR > 20, TV < or equal to 50% predicted, NPS > or equal to 5, Poor cough

Exclusion Criteria:

  • age less than 18 years
  • greater than 80 years
  • GCS less than or equal to 13
  • intubated at admission
  • prior or anticipated exploratory laparotomy during this admission
  • prior or expected thoracotomy during this admission
  • prior or expected emergent craniotomy during this admission
  • spinal cord injury
  • pelvic injury that has required or will require operative intervention
  • inability to accomplish activities of daily living independently
  • pregnancy
  • incarceration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04413799


Contacts
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Contact: Susan Kartiko, MD PhD 7136776219 skartiko@mfa.gwu.edu
Contact: Tremaine Brock tbrock@mfa.gwu.edu

Locations
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United States, District of Columbia
The George Washington University Hospital Recruiting
Washington, District of Columbia, United States, 20037
Contact: Susan Kartiko, MD PhD    713-677-6219    skartiko@mfa.gwu.edu   
Contact: Paul Dangerfield, MD       pdangerfield@mfa.gwu.edu   
Sponsors and Collaborators
George Washington University
Publications:

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Responsible Party: Susan Kartiko, Assistant Professor of Surgery, George Washington University
ClinicalTrials.gov Identifier: NCT04413799    
Other Study ID Numbers: NRC1972020
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Acute Pain
Fractures, Bone
Rib Fractures
Fractures, Multiple
Wounds and Injuries
Thoracic Injuries
Pain
Neurologic Manifestations
Multiple Trauma
Lidocaine
Ketamine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents