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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Liposomal Bupivacaine vs Peripheral Nerve Block

Clinicaltrials.gov identifier NCT03922620

Recruitment Status Recruiting

First Posted April 22, 2019

Last update posted September 22, 2020

Study Description

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.

  • Condition or Disease:Pain, Acute
    Surgery
    Anesthesia
    Opioid Use
  • Intervention/Treatment: Drug: Liposomal bupivacaine
    Drug: Peripheral Nerve Block
  • Phase: Phase 4
Detailed Description

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. Liposomal bupivacaine is an analgesic that is suspended in lipids to allow for gradual release of the analgesic over a 72-hour period (NAMDARI). From prior literature, the utilization of local analgesics infiltrated into surgical sites have been shown to reduce pain in the immediate post-operative period in foot and ankle surgery (GADEK). However, the evaluation of liposomal bupivacaine in foot and ankle surgery is limited. One prospective study found that the addition to liposomal bupivacaine to a multi-modal pain management protocol for forefoot surgery resulted in decreased pain scores during the first four post-operative days as well as fewer refills of opioid pain medication prescriptions, although both findings were not statically significant (ROBBINS). As the general medical community and public policy makers continue to focus on decreasing the amount of opioid pain medications prescribed and available in the community due to the opioid epidemic, liposomal bupivacaine has the potential to be a useful adjunct in the management of post-operative pain without reliance on opioid prescriptions. 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. Furthermore, this study aims to determine if there are differences in the amount of opioid medications utilized for post-operative pain control, patient satisfaction scores, functional outcomes, complications, and unscheduled healthcare contact between the two groups. In order to accomplish these aims, a randomized, controlled investigation will be conducted.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 50 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Liposomal Bupivacaine vs Peripheral Nerve Block
  • Actual Study Start Date: January 2020
  • Estimated Primary Completion Date: January 2021
  • Estimated Study Completion Date: January 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Liposomal Bupivacaine Group
No peripheral nerve block will be given. Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area.
Drug: Liposomal bupivacaine
Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area
Active Comparator: Peripheral Nerve Block Group
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
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).
Outcome Measures
  • Primary Outcome Measures: 1. Visual Analog Scale pain score [ Time Frame: 0-6 weeks ]
    Best 0-10 worst - Continuous scale to measure current pain level
  • Secondary Outcome Measures: 1. morphine equivalents [ Time Frame: 0-6 weeks ]
    morphine equivalents consumed for post-operative pain control
  • 2. investigator-developed, pain satisfaction score [ Time Frame: 0-6 weeks ]
    asks patients to rate their level of satisfaction with their pain control on a scale of 0-10, 0 being not satisfied at all and 10 being highly satisfied
  • 3. range of motion [ Time Frame: 0-6 weeks ]
    range of motion measured using goniometer
  • 4. number of participants with complications [ Time Frame: 0-6 weeks ]
    complications after surgery including infection and delayed healing
  • 5. number of participants with unscheduled healthcare contact [ Time Frame: 0-6 weeks ]
    unscheduled healthcare contact includes patient calls/messages, emergency room visits, or scheduled clinic visits
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

1. Patients 18 years of age or older

2. 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)

Exclusion Criteria:

1. Patients who are undergoing revision surgical procedure

2. Patients who have taken opioid pain medications in the past 3 months prior to surgical
procedure

3. Patients who have allergies to any of the medications or components of medications
investigated in the study

4. Patients currently incarcerated

5. Patients who cannot read and speak English

Contacts and Locations
Contacts

Contact: Gerard Cush, MD 570-214-4806 orthoresearch@geisinger.edu

Contact: Jennifer Harding, MPA 570-214-6178 jlharding1@geisinger.edu

Locations

United States, Pennsylvania
Geisinger Woodbine
Danville

Sponsors and Collaborators

Gerard Cush

Investigators

Principal Investigator: Gerard Cush, MD Geisinger Clinic

More Information
  • Responsible Party: Gerard Cush
  • ClinicalTrials.gov Identifier: NCT03922620 History of Changes
  • Other Study ID Numbers: 2018-0486
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: September 22, 2020
  • Last Verified: September 2020
  • 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: Acute Pain