Liposomal Bupivacaine vs Peripheral Nerve Block

Surgery Clinical Trial

Official title:

Liposomal Bupivacaine vs Peripheral Nerve Block

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03922620
• Other study ID #: 2018-0486
• Status: Terminated
• Phase: Phase 4
• Start date: January 23, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: January 2023
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Anesthesia
• Opioid Use
• Pain, Acute
• Surgery

Intervention

Drug:
• Liposomal bupivacaine
Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area
• 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).

Locations

Country	Name	City	State
United States	Geisinger Woodbine	Danville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Geisinger Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale Pain Score	Best 0-10 worst - Continuous scale to measure current pain level	Baseline and 6 weeks
Secondary	Morphine Equivalents	morphine equivalents consumed for post-operative pain control	0-6 weeks
Secondary	Investigator-developed, Pain Satisfaction Score	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	0-6 weeks
Secondary	Range of Motion	range of motion measured using goniometer	0-6 weeks
Secondary	Number of Participants With Complications	complications after surgery including infection and delayed healing	6 weeks
Secondary	Number of Participants With Unscheduled Healthcare Contact	unscheduled healthcare contact includes patient calls/messages, emergency room visits, or scheduled clinic visits	6 weeks