Bupivacaine Versus Lidocaine Local Anesthesia

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01751347
First received: December 13, 2012
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Carpal Tunnel Syndrome
Trigger Finger
Drug: Bupivacaine
Drug: Lidocaine
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
Official Title: Bupivacaine Versus Lidocaine Local Anesthesia in Elective Outpatient Hand Surgery: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • amount of oral analgesic used post procedure [ Time Frame: up to 2 weeks post surgery ] [ Designated as safety issue: No ]
    Total amount of oral analgesic a subject uses from the day of surgery to 2 weeks post surgery.


Secondary Outcome Measures:
  • Post operative pain [ Time Frame: up to 2 weeks post surgery ] [ Designated as safety issue: No ]
    Pain (subject reported pain scores) experienced at injection, during surgical procedure and post operative pain experienced by subject up to 2 weeks post surgery.


Estimated Enrollment: 84
Study Start Date: February 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751347

Contacts
Contact: Erin Brown, MD 604-875-5866 erin.brown@ubc.ca
Contact: Joline Choi, MBBS, MHS 604-875-4111 ext 68489 joline.choi@vch.ca

Locations
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: Joline Choi, MBBS, MHS    6048754111 ext 68489    joline.choi@vch.ca   
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Erin Brown, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01751347     History of Changes
Other Study ID Numbers: H12-03477
Study First Received: December 13, 2012
Last Updated: October 9, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Local anesthetics
Elective hand surgeries

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Trigger Finger Disorder
Cumulative Trauma Disorders
Median Neuropathy
Mononeuropathies
Muscular Diseases
Musculoskeletal Diseases
Nerve Compression Syndromes
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases
Sprains and Strains
Tendinopathy
Tendon Entrapment
Tenosynovitis
Wounds and Injuries
Anesthetics
Anesthetics, Local
Bupivacaine
Lidocaine
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on October 21, 2014