Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures

NCT03305666 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 17-0685
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Rib fractures represent a common injury pattern this is highly associated with patient morbidity and mortality, as pain control remains a challenge. Even after surgical stabilization of rib fractures (SSRF), unsuccessful pain control can lead to morbid outcomes such as pneumonia and opioid dependence. Multi-modal anesthesia, with the use of thoracic epidurals and para-vertebral injections/catheters, has shown to lessen these occurrences but are subject to a wide array of limitations. A more directed therapy with liposomal bupivacaine has shown to provide sustained analgesia for up to 72 hours in patients who have undergone other types of thoracic surgery, but not SSRF. The hypothesis of the current clinical trial is that, among patients undergoing SSRF, liposomal bupivacaine delivered via video assisted thoracic surgery (VATS) is an intercostal nerve block that provides comparable analgesia to the pain catheter, as measured by pulmonary function, numeric pain scoring, and postoperative narcotic use.

Conditions

Drug Effect; Rib Fractures; Rib Trauma; Surgical Procedure, Unspecified; Pain; Catheter (Other); Nerve Pain; Local Infiltration; Anesthesia, Local; Intercostal Rib; Opioid Dependence; Chest Injury Trauma; Pneumonia

Outcome Measures

Primary Outcomes (1)

• Daily Sequential Clinical Assessment of Respiratory Function (SCARF) Score

  The SCARF score is a validated, dynamic tool that ranges from 0-4, with 0 being the best score and 4 being the worst. One point is given for each of the following four parameters: (1) respiratory rate ≥ 20 breaths per minute; (2) numeric pain score ≥ 5; (3) incentive spirometry \< 50% of predicted based upon a nomogram including sex, height, and age; (4) cough deemed inadequate to clear respiratory secretions by respiratory therapists. The parameters used to calculate the SCARF score are summed to create the total 0-4 score and these results were recorded by clinical personnel not involved in the trial. SCARF scores were taken at 10 am daily for all postoperative inpatient hospital days, however due to variance in length of stay, only scores from the first 5 postoperative days were recorded for the purpose of this results analysis. Scores were then aggregated across the patients and timeframe to result in one median score per group.

  Median SCARF scores were recorded for the first 5 postoperative days.

Secondary Outcomes (2)

• Daily Narcotic Requirements Using Equi-analgesic Doses

  Mean narcotic requirement scores were recorded for the first 5 postoperative hospital inpatient days.

• Percentage of Participants Experiencing Failure of Primary Loco-Regional Analgesia (LRA)

  72 hours

Study Arms (2)

Bupivacaine indwelling catheter

ACTIVE COMPARATOR

Bupivacaine indwelling OnQ pain pump catheter will be placed in the subscapular space at the time of surgery, at infusion of 12 ml/hr of 0.25% bupivacaine, and left in place for a maximum of 120 hours

Drug: Bupivacaine indwelling catheter

Liposomal bupivacaine injection

ACTIVE COMPARATOR

A single injection of liposomal bupivacaine: mixture of 20 mL liposomal bupivacaine, 20 mL 0.25% bupivacaine, and 10 mL sterile saline (50 mL total), will be delivered in the intercostal space during VATS (with a 178 mm, 22 gauge needle, at ribs 3-8).

Drug: Liposomal bupivacaine injection

Interventions

Liposomal bupivacaine injection DRUG

A single injection of liposomal bupivacaine is administered at the time of SSRF, directly to the fracture site via VATS

Also known as: Exparel

Liposomal bupivacaine injection

Bupivacaine indwelling catheter DRUG

Bupivacaine indwelling OnQ pain pump catheter is placed in the subscapular space at the time of SSRF for continuous bupivacaine infusion post op

Also known as: OnQ pain pump, Continuous infusion of bupivacaine

Bupivacaine indwelling catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing SSRF at Denver Health Medical Center

You may not qualify if:

• Allergy or hypersensitivity to bupivacaine
• Pregnancy
• Incarceration
• Age \< 18 years
• Indwelling continuous thoracic epidural analgesia

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead

Study Sites (1)

Denver Health

Denver, Colorado, 80204, United States

Location

Related Publications (1)

• Leasia KN, Ciarallo C, Prins JTH, Preslaski C, Perkins-Pride E, Hardin K, Cralley A, Burlew CC, Coleman JJ, Cohen MJ, Lawless R, Platnick KB, Moore EE, Pieracci FM. A randomized clinical trial of single dose liposomal bupivacaine versus indwelling analgesic catheter in patients undergoing surgical stabilization of rib fractures. J Trauma Acute Care Surg. 2021 Nov 1;91(5):872-878. doi: 10.1097/TA.0000000000003264.

  PMID: 33951024 DERIVED

MeSH Terms

Conditions

Rib Fractures; Pain; Neuralgia; Opioid-Related Disorders; Pneumonia

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

There were no limitations that created barriers to the completion of this project. While this was expected at the outset of this exploratory trial, there was a relatively small sample size with a wide range of fractures for individual participants. Underpowering likely limited analyses of secondary outcomes such as narcotic requirements and failure of LRA. The study also excluded patients with GCS \< 8, so caution should be exercised when extrapolating to mechanically ventilated patients.

Results Point of Contact

• Title: Dr. Fredric Pieracci
• Organization: Denver Health and Hospital Authority

Fredric.Pieracci@dhha.org

(303) 436-4029

Study Officials

• Fredric Pieracci, MD MPH

  Denver Health and Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-inferiority, randomized, clinical trial

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 10, 2017
• Study Start: October 5, 2017
• Primary Completion: July 20, 2020
• Study Completion: January 31, 2021
• Last Updated: September 29, 2021
• Results First Posted: August 25, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)