Carpal Tunnel SyndromePhase 4NCT01751347
Bupivacaine Versus Lidocaine Local Anesthesia
A Phase 4 study testing Bupivacaine and Lidocaine in people with Carpal Tunnel Syndrome and Trigger Finger, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Trigger Finger
- What is being tested?
- Bupivacaine and Lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2013to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 90 year old
- Able to provide informed consent
- Consent to participate
- Carpal tunnel release surgery or Trigger finger release surgery
- Single procedure
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bupivacaine Versus Lidocaine Local Anesthesia in Elective Outpatient Hand Surgery: A Randomized Controlled Trial
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.
Read more
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.
Read the 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.
- Conditions
- Carpal Tunnel Syndrome, Trigger Finger
- Being tested
- Bupivacaine, Lidocaine
- Keywords
- Local anesthetics, Elective hand surgeries
- Medical subject headings
- Carpal Tunnel Syndrome, Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Local anesthetics
LidocaineDrug
Local anesthetics
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | Subjects randomized to this treatment arm will receive lidocaine during their elective hand surgery. Receives: Drug: Lidocaine |
| Bupivacaine | Experimental | Subjects randomized to this treatment arm will receive bupivacaine during their elective hand surgery. Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 weeks post surgery
Secondary outcomes (1)
Post operative pain
Pain (subject reported pain scores) experienced at injection, during surgical procedure and post operative pain experienced by subject up to 2 weeks post surgery.
Measured: up to 2 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin Brown, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751347
- Sponsor's protocol ID
- H12-03477
- Status last verified
- Dec 2015
- First submitted
- 13 Dec 2012
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupivacaine Versus Lidocaine Local Anesthesia in Elective Outpatient Hand Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01751347
- Acronym / sponsor ID
- H12-03477
- Conditions
- Carpal Tunnel Syndrome, Trigger Finger
- Keywords
- Local anesthetics, Elective hand surgeries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: LidocaineSubjects randomized to this treatment arm will receive lidocaine during their elective hand surgery. |
| Bupivacaine | Experimental | Drug: BupivacaineSubjects randomized to this treatment arm will receive bupivacaine during their elective hand surgery. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 - 90 year old
- Able to provide informed consent
- Consent to participate
- Carpal tunnel release surgery or Trigger finger release surgery
- Single procedure
Key exclusion criteria (7 listed)
- Unable to consent
- Do not consent to participate
- Known Lidocaine or Bupivacaine allergy
- Known Epinephrine allergy or contra indication
- Known Codeine allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacaineLocal anesthetics | Drug | Bupivacaine |
| LidocaineLocal anesthetics | Drug | Lidocaine |
Primary outcome
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.
1 secondary outcome
Post operative pain
Time frame: up to 2 weeks post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Brown, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine and Lidocaine in people with Carpal Tunnel Syndrome and Trigger Finger, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of oral analgesic used post procedure (time frame: up to 2 weeks post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.