Liposomal Bupivacaine vs Peripheral Nerve Block

NCT03922620 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2018-0486
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Liposomal bupivacaine has gained interest in recent literature for its potential to be an effective adjunct to other pain control modalities in a multi-modal approach to post-operative pain control. The goal of this investigation is to compare the efficacy of local administration of liposomal bupivacaine versus the efficacy of a peripheral nerve block in terms of post-operative pain scores after elective ankle and hindfoot surgery. The investigators hypothesize that there will not be a significant difference in the pain scores of these two groups in opioid naïve patients.

Conditions

Pain, Acute; Surgery; Anesthesia; Opioid Use

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale Pain Score

  Best 0-10 worst - Continuous scale to measure current pain level

  Baseline and 6 weeks

Secondary Outcomes (5)

• Morphine Equivalents

  0-6 weeks

• Investigator-developed, Pain Satisfaction Score

  0-6 weeks

• Range of Motion

  0-6 weeks

• Number of Participants With Complications

  6 weeks

• Number of Participants With Unscheduled Healthcare Contact

  6 weeks

Study Arms (2)

Liposomal Bupivacaine Group

EXPERIMENTAL

No peripheral nerve block will be given. Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area.

Drug: Liposomal bupivacaine

Peripheral Nerve Block Group

ACTIVE COMPARATOR

Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block). No local analgesic agent infiltration

Drug: Peripheral Nerve Block

Interventions

Liposomal bupivacaine DRUG

Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area

Liposomal Bupivacaine Group

Peripheral Nerve Block DRUG

Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block).

Peripheral Nerve Block Group

Eligibility Criteria

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

You may qualify if:

• Patients 18 years of age or older
• Patients undergoing elective primary ankle or hindfoot surgery (ankle arthrodesis, subtalar arthrodesis, triple arthrodesis, total ankle arthroplasty, peroneal tendon debridement/transfer, Cavus Reconstruction, Medial Displacement Calcaneal Osteotomy, Dwyer Osteotomy)

You may not qualify if:

• Patients who are undergoing revision surgical procedure
• Patients who have taken opioid pain medications in the past 3 months prior to surgical procedure
• Patients who have allergies to any of the medications or components of medications investigated in the study
• Patients currently incarcerated
• Patients who cannot read and speak English

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger Woodbine

Danville, Pennsylvania, 17821, United States

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Gerard Cush
• Organization: Geisinger Medical Center

MSKIresearch@geisinger.edu

5702716700

Study Officials

• Gerard Cush, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 22, 2019
• Study Start: January 23, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: February 23, 2023
• Results First Posted: February 23, 2023

Record last verified: 2023-01

Locations

US (1)