Liposomal Bupivacaine in Ambulatory Hand Surgery

NCT02933814 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: 5150445
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to evaluate pain management regimens following ambulatory hand surgery. Improved pain control may be associated with decreased complications, decreased pain scores, decreased opioid dependence, improved patient comfort and satisfaction, and reduced healthcare costs. Liposomal bupivacaine is an FDA-approved local anesthetic. There will be two groups. One group will receive liposomal bupivacaine. One group will not. The results will be compared. Patients will be over the age of 18 ambulatory hand surgery. Approximately 40 subjects will participate in this study at LLU.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Post-operative Opioid Use

  Patients will record their opioid use post-operatively

  At scheduled intervals up to 168 hours post-operatively

Study Arms (2)

Control Group

NO INTERVENTION

Patients in Group 1 (Plain Bupivacaine) will be treated intra-operatively with injections of 0.25% bupivacaine, with 10 mL (25 mg) delivered to perform a field block of the soft tissue and subfascial plane at the initiation of the surgical procedure.

Experimental Group

EXPERIMENTAL

Patients in Group 2 (Liposomal Bupivacaine + Plain Bupivacaine) will be treated intra-operatively with the initial injection of 0.25% bupivacaine 5 - 10 mL (12.5 - 25 mg) delivered to perform a field block of the soft tissue and subfascial plane at the initiation of the procedure.

Drug: Liposomal Bupivicaine

Interventions

Liposomal Bupivicaine DRUG

Patients in Group 2 (Liposomal Bupivacaine + Plain Bupivacaine) will be treated intra-operatively with the initial injection of 0.25% bupivacaine 5 - 10 mL (12.5 - 25 mg) delivered to perform a field block of the soft tissue and subfascial plane at the initiation of the procedure.

Also known as: Exparel

Experimental 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 and over undergoing ambulatory hand surgery involving soft tissue and subfascial structures, including: CMC arthritis, flexor and extensor tendon injury, symptomatic ganglia, hand and finger fractures

You may not qualify if:

• Patients who are unable to give informed consent to participate in this study
• Patients with a documented history of hypersensitivity reactions to local anesthetic agents
• Patients with a diagnosis of chronic pain disorders such as fibromyalgia, chronic migraine headaches, or psychiatric disorders other than depression or anxiety
• Patients who are currently pregnant
• Patients with impaired hepatic function
• Patients with underlying nerve damage or impairment
• Patients with renal impairment/failure
• Patients whose career/livelihood require a great deal of hand dexterity, in whom a complication could cause a significant impact on life and career (ex: musician, dentist)

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Subhas Gupta, MD

  Chair of the Department of Plastic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of the Department of Plastic Surgery

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 14, 2016
• Study Start: February 9, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: August 7, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)