Liposomal Bupivacaine in Ambulatory Hand Surgery

Pain Clinical Trial

Official title:

Liposomal Bupivacaine in Ambulatory Hand Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02933814
• Other study ID #: 5150445
• Status: Withdrawn
• Phase: Phase 3
• Start date: February 9, 2018
• Est. completion date: February 2019

Study information

• Verified date: August 2019
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Liposomal Bupivicaine
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.

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative Opioid Use	Patients will record their opioid use post-operatively	At scheduled intervals up to 168 hours post-operatively