Liposomal Bupivacaine in Ambulatory Hand Surgery

Loma Linda University (LLU)

Status and phase: Withdrawn; Phase 3

Conditions: Pain

Treatments: Drug: Liposomal Bupivicaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02933814

5150445

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Control Group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Drug: Liposomal Bupivicaine