Liposomal Bupivacaine in Ambulatory Hand Surgery

ID: NCT02933814
Status: Enrolling by invitation
Phase: Phase 4
Start Date: March 01, 2018
First Submitted: October 04, 2016
Last Updated: February 06, 2018
Results: N/A
Organization: Loma Linda University
Sponsors & Collaborators: Loma Linda University
Location: United States
Conditions: Pain
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Study Description

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Pain

Drug: Liposomal Bupivicaine
Other Names
Exparel
Phase 4

Tracking Information

First Submitted DateOctober 04, 2016
Last Update Posted DateFebruary 06, 2018
Anticipated Start DateMarch 01, 2018
Anticipated Completion DateJanuary 01, 2019
Anticipated Primary Completion DateJanuary 01, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Pain [Time Frame: At scheduled intervals up to 168 hours post-operatively]

    Standardized pain scale will be used to record patient's pain levels

  • Opioid Use [Time Frame: At scheduled intervals up to 168 hours post-operatively]

    Patients will record their opioid use post-operatively

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Complications [Time Frame: Any complications that occur will be documented for a minimum of 6 months post-operatively]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleLiposomal Bupivacaine in Ambulatory Hand Surgery
Official TitleLiposomal Bupivacaine in Ambulatory Hand Surgery
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.

Detailed Description

Study TypeInterventional
Study PhasePhase 4
Estimated Enrollment
40
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Single
Primary Purpose
Treatment
Conditions
Pain
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
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.

Other Names
Exparel
Study Groups/Cohorts
Control Group
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
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.

Study Arms
Experimental Experimental Group
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
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.

Arm Intervention/Treatment
Experimental Experimental Group
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

Recruitment Information

Recruitment Status:Enrolling by invitation
Enrollment40
Completion DateJanuary 01, 2019
Eligibility Criteria: 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)
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT02933814
Other Study ID Numbers
5150445
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Loma Linda University
Collaborators
Not Available
Investigators
Principal Investigator
Subhas Gupta, MD
Chair of the Department of Plastic Surgery