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Bupivacaine Versus Lidocaine Local Anesthesia

Descriptive Information
Brief Title † Bupivacaine Versus Lidocaine Local Anesthesia
Official Title † Bupivacaine Versus Lidocaine Local Anesthesia in Elective Outpatient Hand Surgery: A Randomized Controlled Trial
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.
Study Phase Phase 4
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Primary Outcome Measure † amount of oral analgesic used post procedure
Secondary Outcome Measure † Post operative pain
Condition † Carpal Tunnel Syndrome Trigger Finger
Intervention † DrugBupivacaine
Study Arms / Comparison Groups Lidocaine Subjects randomized to this treatment arm will receive lidocaine during their elective hand surgery. Bupivacaine Subjects randomized to this treatment arm will receive bupivacaine during their elective hand surgery.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 84
Start Date † February 2013
Completion Date December 2015
Primary Completion Date August 2015
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
Gender Both
Ages 18 Years - 90 Years
Accepts Healthy Volunteers No
Contacts †† Erin Brown, MD, 604-875-5866, erin.brown@ubc.ca
Location Countries † Canada
Administrative Information
NCT ID † NCT01751347
Organization ID H12-03477
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † University of British Columbia
Collaborators ††
Investigators † Principal Investigator: Erin Brown, MD, University of British Columbia
Information Provided By
Verification Date April 2015
First Received Date † December 13, 2012
Last Updated Date April 10, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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