Carpal Tunnel SyndromeNCT02315573
Lidocaine With Epinephrine vs. Bupivacaine With Epinephrine as Local Anesthetic Agents in Wide-awake Hand Surgery
A study testing Wrist block anesthesia in people with Carpal Tunnel Syndrome, run by St. Mary's Research Center, Canada at 1 site in Canada.
Trial summary
This study is focused on comparing patients' pain scores on a visual analogue scale (VAS) and the difference in analgesics use post-operatively (with the same prescription defining only the maximum frequency) between lidocaine with epinephrine \& bupivacaine with epinephrine as local anesthetics in wide-awake hand… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Wrist block anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Apr 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years old
- First time carpal tunnel surgery
Who cannot join
- Regular analgesic medication consumption
- More than one surgical procedure at the same time as carpal tunnel surgery
- Need for a surrogate decision maker
- Allergic or unable to take morphine, hydromorphone (Dilaudid), acetaminophen (Tylenol), lidoxaine (Xylocaine), bupivacaine (Marcane), or epinephrine
- End stage kidney disease
- End stage liver disease
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lidocaine With Epinephrine vs. Bupivacaine With Epinephrine as Local Anesthetic Agents in Wide-awake Hand Surgery: an Outcome Study of Patients' Pain Perception.
This study is focused on comparing patients' pain scores on a visual analogue scale (VAS) and the difference in analgesics use post-operatively (with the same prescription defining only the maximum frequency) between lidocaine with epinephrine \& bupivacaine with epinephrine as local anesthetics in wide-awake hand surgery. The investigators' hypothesis states that a longer acting local anesthetic agent (bupivacaine) would be able to provide better postoperative pain relief demonstrated by lower pain scores on VAS and less analgesics use (as will be recorded on the patient's log). This will be mainly obvious in the first 24 hours postoperative period when the pain is usually at maximum levels and starts to decline thereafter. If the investigators' hypothesis is true, this may potentially change practices of many hand surgeons towards the routine use of longer acting local anesthetics particularly in wide-awake hand surgery, and perhaps could be extrapolated to other surgical specialties. Further, a reduction in postoperative analgesics use would be of paramount clinical importance, as it would reduce their potential side effects.
Read the detailed description
The purpose of this study is to better understand the differences of two commonly used local anesthetics in carpal tunnel surgery. This study will explore the differences in terms of patient satisfaction during surgery (measured on VAS), pain after surgery (measured on VAS), and the need for pain medications after surgery (patients will annotate on a log given to them the time of the medication taken if needed for analgesia).
Wide awake hand surgery (freezing your limb while being fully awake) has recently been popularized as being faster and safer for patients compared to hand surgery under general anesthesia or with sedation. Advantages include fast recovery and no risks of general anesthesia.
In order to freeze the wrist to undergo carpal tunnel surgery, a local anesthetic is injected into the nerves of the wrist. Among the most commonly used anesthetic agents are Lidocaine (shorter duration of anesthesia) and Bupivacaine (longer duration of anesthesia). Until now, no enough evidence to support using one anesthetic agent over the other. Furthermore, no previous studies looked at the perception of pain from patient's perspectives when using different anesthetic agents.
There will be NO change in the standard medical care that patients will receive whether or not patients decide to participate in the study. Patients that join the study will receive the same anesthetic agents used in those procedures as patients who decide not to participate. The only difference will be collecting clinical data from participants and asking participants to complete two questionnaires regarding the surgical experience, and the perceived level of pain during the two days that follow surgery. As well, participants will be asked to keep a simple log of the pain medications that are consumed during the two days after the surgery. Patients' total participation time should take no more than 30 minutes.
Patients' decision to participate in this study will help doctors in the future to decide which of these two used anesthetic agents (Lidocaine or Bupivacaine) gives patients the best experience during surgery. As well, it will help reduce the pain that some patients experience after surgery, as well as reduce the need for pain medications after surgery.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Wrist block anesthesia
- Keywords
- Carpal Tunnel Syndrome, Anesthetics, Local, Pain Perception, Pain Measurement, Analgesia, Lidocaine, Bupivacaine
- Medical subject headings
- Carpal Tunnel Syndrome, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist block anesthesiaProcedure or surgery
Also called Lidocaine with epinephrine, Bupivacain with epinephrine
The carpal tunnel release surgery will be performed under wrist block anesthesia. Group 1 will have the wrist block performed with Lidocaine and epinephrine, while Group 2 with Bupivacaine and epinephrine.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine with epinephrine | Experimental | Wrist block anesthesia with Lidocaine 1% with epinephrine; 10cc.
Group 1 will receive the same treatment as group 2, except that the wide-awake carpal tunnel release surgery will be performed under Lidocaine anesthesia instead of Bupivacaine anesthesia. Receives: Procedure: Wrist block anesthesia |
| Bupivacaine with epinephrine | Experimental | Wrist block anesthesia with Bupivacaine 0.25% with epinephrine; 10cc.
Group 2 will receive the same treatment as group 1, except that the wide-awake carpal tunnel release surgery will be performed under Bupivacaine anesthesia instead of Lidocaine anesthesia. Receives: Procedure: Wrist block anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores on a visual analogue scale
Patients' pain scores on a visual analogue scale over the first 24 hours after surgery.
Measured: 24 hours
Pattern and amount of analgesics consumed
The time of consumption and the type of analgesic (acetaminophen 1g PO q6hr PRN or morphine 5mg PO q4hr PRN) consumed over the first 48 hours after surgery. This will be recorded in the medication log given to patients.
Measured: 48 hours
Secondary outcomes (2)
Pain scores on a visual analogue scale
Patients' pain scores on a visual analogue scale perceived between the first 24 hours and 48 hours after surgery.
Measured: 24 hours
Patient satisfaction scores on a visual analogue scale
Patient self rated satisfaction on a visual analogue scale with wide-awake carpal tunnel release surgery. Will be measured immediately after surgery.
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Mary's Research Center, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mario Luc, St. Mary's Research Center, Canada
- Investigators
- Mario Luc, MD, FRCSC, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315573
- Sponsor's protocol ID
- SMHC #14-30
- Status last verified
- Apr 2019
- First submitted
- 3 Dec 2014
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wildin C, Dias JJ, Heras-Palou C, Bradley MJ, Burke FD. Trends in elective hand surgery referrals from primary care. Ann R Coll Surg Engl. 2006 Oct;88(6):543-6. doi: 10.1308/003588406X117070.
PubMed 17059713Angermann P, Lohmann M. Injuries to the hand and wrist. A study of 50,272 injuries. J Hand Surg Br. 1993 Oct;18(5):642-4. doi: 10.1016/0266-7681(93)90024-a.
PubMed 8294834Larsen CF, Mulder S, Johansen AM, Stam C. The epidemiology of hand injuries in The Netherlands and Denmark. Eur J Epidemiol. 2004;19(4):323-7. doi: 10.1023/b:ejep.0000024662.32024.e3.
PubMed 15180102Neill RS. Postoperative analgesia following brachial plexus block. Br J Anaesth. 1978 Apr;50(4):379-82. doi: 10.1093/bja/50.4.379.
PubMed 656255Ganzberg S, Kramer KJ. The use of local anesthetic agents in medicine. Dent Clin North Am. 2010 Oct;54(4):601-10. doi: 10.1016/j.cden.2010.06.001.
PubMed 20831924Alhelail M, Al-Salamah M, Al-Mulhim M, Al-Hamid S. Comparison of bupivacaine and lidocaine with epinephrine for digital nerve blocks. Emerg Med J. 2009 May;26(5):347-50. doi: 10.1136/emj.2008.062497.
PubMed 19386869Conolly WB, Berry FR. The place of peripheral nerve blocks in reconstructive hand surgery. Hand. 1977 Jun;9(2):157-9. doi: 10.1016/s0072-968x(77)80011-9.
PubMed 914091Lalonde DH. Reconstruction of the hand with wide awake surgery. Clin Plast Surg. 2011 Oct;38(4):761-9. doi: 10.1016/j.cps.2011.07.005.
PubMed 22032599Pratap JN, Shankar RK, Goroszeniuk T. Co-injection of clonidine prolongs the anesthetic effect of lidocaine skin infiltration by a peripheral action. Anesth Analg. 2007 Apr;104(4):982-3. doi: 10.1213/01.ane.0000257949.46444.a8.
PubMed 17377118Reinhart DJ, Stagg KS, Walker KG, Wang WP, Parker CM, Jackson HH, Walker EB. Postoperative analgesia after peripheral nerve block for podiatric surgery: clinical efficacy and chemical stability of lidocaine alone versus lidocaine plus ketorolac. Reg Anesth Pain Med. 2000 Sep-Oct;25(5):506-13. doi: 10.1053/rapm.2000.7624.
PubMed 11009237Thomson CJ, Lalonde DH. Randomized double-blind comparison of duration of anesthesia among three commonly used agents in digital nerve block. Plast Reconstr Surg. 2006 Aug;118(2):429-32. doi: 10.1097/01.prs.0000227632.43606.12.
PubMed 16874214Reichl M, Quinton D. Comparison of 1% lignocaine with 0.5% bupivacaine in digital ring blocks. J Hand Surg Br. 1987 Oct;12(3):375-6. doi: 10.1016/0266-7681_87_90192-6.
PubMed 3325593Gorzack A. Towards evidence based emergency medicine: best BETs from the Manchester Royal Infirmary. Lignocaine or bupivacaine for digital ring block. J Accid Emerg Med. 1998 Sep;15(5):353. doi: 10.1136/emj.15.5.353. No abstract available.
PubMed 10454811Valvano MN, Leffler S. Comparison of bupivacaine and lidocaine/bupivacaine for local anesthesia/digital nerve block. Ann Emerg Med. 1996 Apr;27(4):490-2. doi: 10.1016/s0196-0644(96)70239-1.
PubMed 8604868Nystrom A, Lindstrom G, Reiz S, Hanel DP. Bupivacaine: a safe local anesthetic for wrist blocks. J Hand Surg Am. 1989 May;14(3):495-8. doi: 10.1016/s0363-5023(89)80010-3.
PubMed 2544640
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine With Epinephrine vs. Bupivacaine With Epinephrine as Local Anesthetic Agents in Wide-awake Hand Surgery: an Outcome Study of Patients' Pain Perception.
- ClinicalTrials.gov ID
- NCT02315573
- Acronym / sponsor ID
- SMHC #14-30
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Syndrome, Anesthetics, Local, Pain Perception, Pain Measurement, Analgesia, Lidocaine, Bupivacaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- St. Mary's Research Center, CanadaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 12 Dec 2014 (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.
This study is focused on comparing patients' pain scores on a visual analogue scale (VAS) and the difference in analgesics use post-operatively (with the same prescription defining only the maximum frequency) between lidocaine with epinephrine \& bupivacaine with epinephrine as local anesthetics in wide-awake hand surgery. The investigators' hypothesis states that a longer acting local anesthetic agent (bupivacaine) would be able to provide better postoperative pain relief demonstrated by lower pain scores on VAS and less analgesics use (as will be recorded on the patient's log). This will be mainly obvious in the first 24 hours postoperative period when the pain is usually at maximum levels and starts to decline thereafter. If the investigators' hypothesis is true, this may potentially change practices of many hand surgeons towards the routine use of longer acting local anesthetics particularly in wide-awake hand surgery, and perhaps could be extrapolated to other surgical specialties. Further, a reduction in postoperative analgesics use would be of paramount clinical importance, as it would reduce their potential side effects.
Detailed description
The purpose of this study is to better understand the differences of two commonly used local anesthetics in carpal tunnel surgery. This study will explore the differences in terms of patient satisfaction during surgery (measured on VAS), pain after surgery (measured on VAS), and the need for pain medications after surgery (patients will annotate on a log given to them the time of the medication taken if needed for analgesia).
Wide awake hand surgery (freezing your limb while being fully awake) has recently been popularized as being faster and safer for patients compared to hand surgery under general anesthesia or with sedation. Advantages include fast recovery and no risks of general anesthesia.
In order to freeze the wrist to undergo carpal tunnel surgery, a local anesthetic is injected into the nerves of the wrist. Among the most commonly used anesthetic agents are Lidocaine (shorter duration of anesthesia) and Bupivacaine (longer duration of anesthesia). Until now, no enough evidence to support using one anesthetic agent over the other. Furthermore, no previous studies looked at the perception of pain from patient's perspectives when using different anesthetic agents.
There will be NO change in the standard medical care that patients will receive whether or not patients decide to participate in the study. Patients that join the study will receive the same anesthetic agents used in those procedures as patients who decide not to participate. The only difference will be collecting clinical data from participants and asking participants to complete two questionnaires regarding the surgical experience, and the perceived level of pain during the two days that follow surgery. As well, participants will be asked to keep a simple log of the pain medications that are consumed during the two days after the surgery. Patients' total participation time should take no more than 30 minutes.
Patients' decision to participate in this study will help doctors in the future to decide which of these two used anesthetic agents (Lidocaine or Bupivacaine) gives patients the best experience during surgery. As well, it will help reduce the pain that some patients experience after surgery, as well as reduce the need for pain medications after surgery.
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 with epinephrine | Experimental | Procedure: Wrist block anesthesiaWrist block anesthesia with Lidocaine 1% with epinephrine; 10cc. Group 1 will receive the same treatment as group 2, except that the wide-awake carpal tunnel release surgery will be performed under Lidocaine anesthesia instead of Bupivacaine anesthesia. |
| Bupivacaine with epinephrine | Experimental | Procedure: Wrist block anesthesiaWrist block anesthesia with Bupivacaine 0.25% with epinephrine; 10cc. Group 2 will receive the same treatment as group 1, except that the wide-awake carpal tunnel release surgery will be performed under Bupivacaine anesthesia instead of Lidocaine anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 18 years old
- First time carpal tunnel surgery
Key exclusion criteria (7 listed)
- Regular analgesic medication consumption
- More than one surgical procedure at the same time as carpal tunnel surgery
- Need for a surrogate decision maker
- Allergic or unable to take morphine, hydromorphone (Dilaudid), acetaminophen (Tylenol), lidoxaine (Xylocaine), bupivacaine (Marcane), or epinephrine
- End stage kidney disease
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 |
|---|---|---|
| Wrist block anesthesiaAlso: Lidocaine with epinephrine, Bupivacain with epinephrineThe carpal tunnel release surgery will be performed under wrist block anesthesia. Group 1 will have the wrist block performed with Lidocaine and epinephrine, while Group 2 with Bupivacaine and epinephrine. | Procedure or surgery | Bupivacaine with epinephrine, Lidocaine with epinephrine |
Primary outcome
Pain scores on a visual analogue scale
Time frame: 24 hours
Patients' pain scores on a visual analogue scale over the first 24 hours after surgery.
Pattern and amount of analgesics consumed
Time frame: 48 hours
The time of consumption and the type of analgesic (acetaminophen 1g PO q6hr PRN or morphine 5mg PO q4hr PRN) consumed over the first 48 hours after surgery. This will be recorded in the medication log given to patients.
2 secondary outcomes
Pain scores on a visual analogue scale
Time frame: 24 hours
Patient satisfaction scores on a visual analogue scale
Time frame: Immediate
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 23 Apr 2019.
- Background: PubMed 17059713Wildin C, Dias JJ, Heras-Palou C, Bradley MJ, Burke FD. Trends in elective hand surgery referrals from primary care. Ann R Coll Surg Engl. 2006 Oct;88(6):543-6. doi: 10.1308/003588406X117070.
- Background: PubMed 8294834Angermann P, Lohmann M. Injuries to the hand and wrist. A study of 50,272 injuries. J Hand Surg Br. 1993 Oct;18(5):642-4. doi: 10.1016/0266-7681(93)90024-a.
- Background: PubMed 15180102Larsen CF, Mulder S, Johansen AM, Stam C. The epidemiology of hand injuries in The Netherlands and Denmark. Eur J Epidemiol. 2004;19(4):323-7. doi: 10.1023/b:ejep.0000024662.32024.e3.
- Background: PubMed 656255Neill RS. Postoperative analgesia following brachial plexus block. Br J Anaesth. 1978 Apr;50(4):379-82. doi: 10.1093/bja/50.4.379.
- Background: PubMed 20831924Ganzberg S, Kramer KJ. The use of local anesthetic agents in medicine. Dent Clin North Am. 2010 Oct;54(4):601-10. doi: 10.1016/j.cden.2010.06.001.
- Background: PubMed 19386869Alhelail M, Al-Salamah M, Al-Mulhim M, Al-Hamid S. Comparison of bupivacaine and lidocaine with epinephrine for digital nerve blocks. Emerg Med J. 2009 May;26(5):347-50. doi: 10.1136/emj.2008.062497.
- Background: PubMed 914091Conolly WB, Berry FR. The place of peripheral nerve blocks in reconstructive hand surgery. Hand. 1977 Jun;9(2):157-9. doi: 10.1016/s0072-968x(77)80011-9.
- Background: PubMed 22032599Lalonde DH. Reconstruction of the hand with wide awake surgery. Clin Plast Surg. 2011 Oct;38(4):761-9. doi: 10.1016/j.cps.2011.07.005.
- Background: PubMed 17377118Pratap JN, Shankar RK, Goroszeniuk T. Co-injection of clonidine prolongs the anesthetic effect of lidocaine skin infiltration by a peripheral action. Anesth Analg. 2007 Apr;104(4):982-3. doi: 10.1213/01.ane.0000257949.46444.a8.
- Background: PubMed 11009237Reinhart DJ, Stagg KS, Walker KG, Wang WP, Parker CM, Jackson HH, Walker EB. Postoperative analgesia after peripheral nerve block for podiatric surgery: clinical efficacy and chemical stability of lidocaine alone versus lidocaine plus ketorolac. Reg Anesth Pain Med. 2000 Sep-Oct;25(5):506-13. doi: 10.1053/rapm.2000.7624.
- Background: PubMed 16874214Thomson CJ, Lalonde DH. Randomized double-blind comparison of duration of anesthesia among three commonly used agents in digital nerve block. Plast Reconstr Surg. 2006 Aug;118(2):429-32. doi: 10.1097/01.prs.0000227632.43606.12.
- Background: PubMed 3325593Reichl M, Quinton D. Comparison of 1% lignocaine with 0.5% bupivacaine in digital ring blocks. J Hand Surg Br. 1987 Oct;12(3):375-6. doi: 10.1016/0266-7681_87_90192-6.
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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.
Mario Luc, MD, FRCSC principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wrist block anesthesia in people with Carpal Tunnel Syndrome, run by St. Mary's Research Center, Canada 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 2 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 23 Apr 2019. 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.
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?
Pain scores on a visual analogue scale (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02315573, which also lists 17 linked publications.
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 23 Apr 2019.