Bupivacaine Versus Lidocaine Local Anesthesia

NCT01751347 | Completed Phase 4

• 1 other identifier: H12-03477
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome; Trigger Finger

Keywords

Local anesthetics; Elective hand surgeries

Outcome Measures

Primary Outcomes (1)

• amount of oral analgesic used post procedure

  Total amount of oral analgesic a subject uses from the day of surgery to 2 weeks post surgery.

  up to 2 weeks post surgery

Secondary Outcomes (1)

• Post operative pain

  up to 2 weeks post surgery

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

Subjects randomized to this treatment arm will receive lidocaine during their elective hand surgery.

Drug: Lidocaine

Bupivacaine

EXPERIMENTAL

Subjects randomized to this treatment arm will receive bupivacaine during their elective hand surgery.

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

Local anesthetics

Bupivacaine

Lidocaine DRUG

Local anesthetics

Lidocaine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year old
• Able to provide informed consent
• Consent to participate
• Carpal tunnel release surgery or Trigger finger release surgery
• Single procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Trigger Finger Disorder

Interventions

Bupivacaine; Lidocaine

Condition Hierarchy (Ancestors)

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; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides

Study Officials

• Erin Brown, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: December 18, 2012
• Study Start: February 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 14, 2015

Record last verified: 2015-12

Locations

CA (1)