PVB vs Ketamine/Lidocaine in Rib Fracture Patients

January 5, 2024 updated by: Susan Kartiko, George Washington University

Paravertebral Block Versus Simultaneous Ketamine and Lidocaine Infusions for Pain Management in Rib Fracture Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20037

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
throughout patients' hospitalization time, an average of 1 week
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.
throughout patients' hospitalization time, an average of 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
captured after patient is discharged, an average of 1 week
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.
captured after patient is discharged, an average of 1 week
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.
throughout patients' hospitalization time, an average of 1 week
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
throughout patients' hospitalization time, an average of 1 week
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
captured after patient is discharged, an average of 1 week
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
captured after patient is discharged, an average of 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Washington University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

May 30, 2025

Study Registration Dates

First Submitted

May 26, 2020

First Submitted That Met QC Criteria

May 29, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRC1972020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared with other researchers.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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