Liposomal Bupivacaine vs Peripheral Nerve Block

Phase 4

Terminated

Conditions: Pain, Acute
Surgery
Anesthesia
Opioid Use

Interventions: Drug: Liposomal bupivacaine
Drug: Peripheral Nerve Block

Registration Number: NCT03922620

Lead Sponsor: Geisinger Clinic

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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 1

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposomal Bupivacaine Group	Liposomal bupivacaine	No peripheral nerve block will be given. Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area.
Peripheral Nerve Block Group	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). No local analgesic agent infiltration

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale Pain Score	Baseline and 6 weeks	Best 0-10 worst - Continuous scale to measure current pain level

Secondary Outcome Measures

Name	Time	Method
Range of Motion	0-6 weeks	range of motion measured using goniometer
Morphine Equivalents	0-6 weeks	morphine equivalents consumed for post-operative pain control
Investigator-developed, Pain Satisfaction Score	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
Number of Participants With Complications	6 weeks	complications after surgery including infection and delayed healing
Number of Participants With Unscheduled Healthcare Contact	6 weeks	unscheduled healthcare contact includes patient calls/messages, emergency room visits, or scheduled clinic visits