Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
135 participants
INTERVENTIONAL
2013-02-28
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lidocaine
Subjects randomized to this treatment arm will receive lidocaine during their elective hand surgery.
Lidocaine
Local anesthetics
Bupivacaine
Subjects randomized to this treatment arm will receive bupivacaine during their elective hand surgery.
Bupivacaine
Local anesthetics
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bupivacaine
Local anesthetics
Lidocaine
Local anesthetics
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Able to provide informed consent
* Consent to participate
* Carpal tunnel release surgery or Trigger finger release surgery
* Single procedure
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of British Columbia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Erin Brown, MD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vancouver General Hospital
Vancouver, British Columbia, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H12-03477
Identifier Type: -
Identifier Source: org_study_id