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Bupivacaine Versus Lidocaine Local Anesthesia

Primary Purpose

Carpal Tunnel Syndrome, Trigger Finger

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Bupivacaine
Lidocaine
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Local anesthetics, Elective hand surgeries

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 - 90 year old
  • Able to provide informed consent
  • Consent to participate
  • Carpal tunnel release surgery or Trigger finger release surgery
  • Single procedure

Exclusion Criteria:

  • Unable to consent
  • Do not consent to participate
  • Known Lidocaine or Bupivacaine allergy
  • Known Epinephrine allergy or contra indication
  • Known Codeine allergy
  • Pregnant
  • More than one procedure is being performed at the same setting

Sites / Locations

  • Vancouver General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Lidocaine

Bupivacaine

Arm Description

Subjects randomized to this treatment arm will receive lidocaine during their elective hand surgery.

Subjects randomized to this treatment arm will receive bupivacaine during their elective hand surgery.

Outcomes

Primary Outcome Measures

amount of oral analgesic used post procedure
Total amount of oral analgesic a subject uses from the day of surgery to 2 weeks post surgery.

Secondary Outcome Measures

Post operative pain
Pain (subject reported pain scores) experienced at injection, during surgical procedure and post operative pain experienced by subject up to 2 weeks post surgery.

Full Information

First Posted
December 13, 2012
Last Updated
December 10, 2015
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT01751347
Brief Title
Bupivacaine Versus Lidocaine Local Anesthesia
Official Title
Bupivacaine Versus Lidocaine Local Anesthesia in Elective Outpatient Hand Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The use of local anesthetics has become an important aspect of pain management in surgical settings and is currently recommended in pain management guidelines. Elective outpatient hand surgeries, such as carpal tunnel or trigger finger release, cause minimum tissue disruption and are short in duration. As a result, these local anesthetic agents are a major component in post-operative pain control. The most commonly used local anesthetic agents are Lidocaine and Bupivacaine. Lidocaine acts faster (within 2-5 minutes of injection) and for this reason is often favored in outpatient setting for pre-incisional injection. However its effects only last up to 2 hours, without epinephrine, and 3 hours, with epinephrine. On the other hand, Bupivacaine, has a slower onset of action (about 5-10 minutes after injection) but its effects last much longer, for about 4-8 hours. The delay in onset of action makes it a less popular option as a primary source of local anesthesia in outpatient hand surgery. Given the longer duration of anesthesia offered by Bupivacaine, the investigators believe that by giving it pre-operatively in elective outpatient hand surgeries will offer more effective post operative pain control compared to using Lidocaine only. There is limited published data confirming the effectiveness of use of pre-operative Bupivicaine in improved postoperative pain control and decreased consumption of narcotics. Therefore, the aim in this study is to compare the postoperative pain experienced by patients undergoing either elective carpal tunnel release or trigger finger release as well as their use of pain medications when the incision site is infiltrated preemptively with Lidocaine versus Bupivacaine. The investigators believe that adequate post surgical pain control is essential for patients' full functional recovery. Poorly controlled post surgical pain increases incidence of surgery related complications and thus increased health care costs. It can also reduce patients' mobility, delay their return to full function,. If poorly controlled, post surgical pain may progress to chronic pain and rarely complex regional pain syndromes may ensue.
Detailed Description
Subjects will be randomized to receive either 10ml of 0.5% Bupivacaine with 1:200,000 Epinephrine or 10 ml of 1% Lidocaine with 1:100,000 Epinephrine. In the case of a single digit surgery such as the trigger finger release, the dose will be adjusted to 5ml of 0.5% Bupivacaine with 1:200,000 Epinephrine or 5ml of 1% Lidocaine with 1:100,000 Epinephrine. An additional 5ml of study drug will be prepared in a separate syringe and administered when needed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Trigger Finger
Keywords
Local anesthetics, Elective hand surgeries

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
Subjects randomized to this treatment arm will receive lidocaine during their elective hand surgery.
Arm Title
Bupivacaine
Arm Type
Experimental
Arm Description
Subjects randomized to this treatment arm will receive bupivacaine during their elective hand surgery.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Local anesthetics
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Local anesthetics
Primary Outcome Measure Information:
Title
amount of oral analgesic used post procedure
Description
Total amount of oral analgesic a subject uses from the day of surgery to 2 weeks post surgery.
Time Frame
up to 2 weeks post surgery
Secondary Outcome Measure Information:
Title
Post operative pain
Description
Pain (subject reported pain scores) experienced at injection, during surgical procedure and post operative pain experienced by subject up to 2 weeks post surgery.
Time Frame
up to 2 weeks post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 - 90 year old Able to provide informed consent Consent to participate Carpal tunnel release surgery or Trigger finger release surgery Single procedure Exclusion Criteria: Unable to consent Do not consent to participate Known Lidocaine or Bupivacaine allergy Known Epinephrine allergy or contra indication Known Codeine allergy Pregnant More than one procedure is being performed at the same setting
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Brown, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

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Bupivacaine Versus Lidocaine Local Anesthesia

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