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Bupivacaine Versus Lidocaine Local Anesthesia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01751347
First Posted: December 18, 2012
Last Update Posted: December 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of British Columbia
December 13, 2012
December 18, 2012
December 14, 2015
February 2013
December 2015   (Final data collection date for primary outcome measure)
amount of oral analgesic used post procedure [ Time Frame: up to 2 weeks post surgery ]
Total amount of oral analgesic a subject uses from the day of surgery to 2 weeks post surgery.
Same as current
Complete list of historical versions of study NCT01751347 on ClinicalTrials.gov Archive Site
Post operative pain [ Time Frame: up to 2 weeks post surgery ]
Pain (subject reported pain scores) experienced at injection, during surgical procedure and post operative pain experienced by subject up to 2 weeks post surgery.
Same as current
Not Provided
Not Provided
 
Bupivacaine Versus Lidocaine Local Anesthesia
Bupivacaine Versus Lidocaine Local Anesthesia in Elective Outpatient Hand Surgery: A Randomized Controlled Trial

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
  • Carpal Tunnel Syndrome
  • Trigger Finger
  • Drug: Bupivacaine
    Local anesthetics
  • Drug: Lidocaine
    Local anesthetics
  • Active Comparator: Lidocaine
    Subjects randomized to this treatment arm will receive lidocaine during their elective hand surgery.
    Intervention: Drug: Lidocaine
  • Experimental: Bupivacaine
    Subjects randomized to this treatment arm will receive bupivacaine during their elective hand surgery.
    Intervention: Drug: Bupivacaine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
135
December 2015
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01751347
H12-03477
No
Not Provided
Not Provided
University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Erin Brown, MD University of British Columbia
University of British Columbia
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP