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Bupivacaine Versus Lidocaine Local Anesthesia

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. Identifier: NCT01751347
Recruitment Status : Completed
First Posted : December 18, 2012
Last Update Posted : December 14, 2015
Information provided by (Responsible Party):
University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Trigger Finger Drug: Bupivacaine Drug: Lidocaine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Bupivacaine Versus Lidocaine Local Anesthesia in Elective Outpatient Hand Surgery: A Randomized Controlled Trial
Study Start Date : February 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Active Comparator: Lidocaine
Subjects randomized to this treatment arm will receive lidocaine during their elective hand surgery.
Drug: Lidocaine
Local anesthetics

Experimental: Bupivacaine
Subjects randomized to this treatment arm will receive bupivacaine during their elective hand surgery.
Drug: Bupivacaine
Local anesthetics

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01751347

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Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
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Principal Investigator: Erin Brown, MD University of British Columbia
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Responsible Party: University of British Columbia Identifier: NCT01751347    
Other Study ID Numbers: H12-03477
First Posted: December 18, 2012    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015
Keywords provided by University of British Columbia:
Local anesthetics
Elective hand surgeries
Additional relevant MeSH terms:
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Trigger Finger Disorder
Carpal Tunnel Syndrome
Median Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Tendon Entrapment
Muscular Diseases
Musculoskeletal Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action