Clinical trial NCT03922620: Liposomal Bupivacaine vs Peripheral Nerve Block
Official title: Liposomal Bupivacaine vs Peripheral Nerve Block
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain, Acute
Surgery
Anesthesia
Opioid Use
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Visual Analog Scale Pain Score
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Morphine Equivalents
timeFrame: 0-6 weeks
measure: Investigator-developed, Pain Satisfaction Score
timeFrame: 0-6 weeks
measure: Range of Motion
timeFrame: 0-6 weeks
measure: Number of Participants With Complications
timeFrame: 6 weeks
measure: Number of Participants With Unscheduled Healthcare Contact
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Woodbine
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Gerard Cush, MD
role: PRINCIPAL_INVESTIGATOR
References: