Bupivacaine Versus Lidocaine Local Anesthesia
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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, we 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, our 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.
We 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 |
|---|---|---|
|
Elective Hand Surgery Carpal Tunnel Syndrome Release Trigger Finger Release |
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 |
- 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.
- 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: | August 2014 |
| Estimated Primary Completion Date: | December 2013 (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
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| 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 |
| Canada, British Columbia | |
| Vancouver General Hospital | Recruiting |
| Vancouver, British Columbia, Canada | |
| Contact: Joline Choi, MBBS, MHS 6048754111 ext 68489 joline.choi@vch.ca | |
| 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: | February 6, 2013 |
| 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 Median Neuropathy Mononeuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Nerve Compression Syndromes Cumulative Trauma Disorders Sprains and Strains Wounds and Injuries Tendon Entrapment Tenosynovitis Tendinopathy Muscular Diseases |
Musculoskeletal Diseases Anesthetics Bupivacaine Lidocaine Anesthetics, Local Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 18, 2013