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NCT04833777

Does a Different Local Anesthetic Improve Pain After Carpal Tunnel Release?

Completed NA Results posted Last updated 10 February 2025
What this trial tests

NA trial testing Local Anesthetics Lidocaine in Carpal Tunnel Syndrome in 140 participants. Completed in 1 December 2022.

Timeline
1 July 2021
Primary endpoint
1 December 2022
1 December 2022

Quick facts

Lead sponsorUniversity of Saskatchewan
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingdouble
Primary purposetreatment
Enrollment140
Start date1 July 2021
Primary completion1 December 2022
Estimated completion1 December 2022
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University of Saskatchewan

Who can join

18 and older, any sex, with Carpal Tunnel Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Post-operative Pain Primary · 2 hours post-op

Severity of pain as measured by the Visual Analogue Scale. This tool asks patients to rate their post-operative pain level from 0 to 10. 0 represents no pain, while 10 represents the worst possible pain.

GroupValue95% CI
Lidocaine1.16± 1.83
Bupivacaine0.92± 1.61
Post-operative Pain Primary · 4 hours post-op

Severity of pain as measured by the Visual Analogue Scale. This tool asks patients to rate their post-operative pain level from 0 to 10. 0 represents no pain, while 10 represents the worst possible pain.

GroupValue95% CI
Lidocaine2.16± 2.23
Bupivacaine1.54± 1.98
Post-operative Pain Primary · 6 hours post-op

Severity of pain as measured by the Visual Analogue Scale. This tool asks patients to rate their post-operative pain level from 0 to 10. 0 represents no pain, while 10 represents the worst possible pain.

GroupValue95% CI
Lidocaine3.19± 2.29
Bupivacaine2.29± 2.35
Post-operative Pain Primary · 8 hours post-op

Severity of pain as measured by the Visual Analogue Scale. This tool asks patients to rate their post-operative pain level from 0 to 10. 0 represents no pain, while 10 represents the worst possible pain.

GroupValue95% CI
Lidocaine3.87± 2.24
Bupivacaine2.92± 2.30
Post-operative Pain Primary · 10 hours post-op

Severity of pain as measured by the Visual Analogue Scale. This tool asks patients to rate their post-operative pain level from 0 to 10. 0 represents no pain, while 10 represents the worst possible pain.

GroupValue95% CI
Lidocaine3.81± 2.32
Bupivacaine3.38± 2.42
Post-operative Pain Primary · 24 hours post-op

Severity of pain as measured by the Visual Analogue Scale. This tool asks patients to rate their post-operative pain level from 0 to 10. 0 represents no pain, while 10 represents the worst possible pain.

GroupValue95% CI
Lidocaine3.22± 2.22
Bupivacaine3.38± 2.35
Post-operative Analgesia Requirements Primary · 24 hours

Number of Tylenol and Ibuprofen tablets taken post-operatively within the first 24 hours. This was not measured on a scale. Patients were asked to count the total number of Tylenol (500mg) and Ibuprofen (200mg) tablets they consumed within the first 24 hours after surgery.

GroupValue95% CI
Lidocaine7.45± 4.70
Bupivacaine7.31± 4.57
Post-operative Analgesia Requirements Primary · 72 hours

Number of Tylenol and Ibuprofen tablets taken post-operatively within the first 24 hours. This was not measured on a scale. Patients were asked to count the total number of Tylenol (500mg) and Ibuprofen (200mg) tablets they consumed within the first 72 hours after surgery.

GroupValue95% CI
Lidocaine14.5± 11.8
Bupivacaine13± 8.9
Post-operative Numbness Secondary · 2 hours post-op

Presence of post-operative numbness in any finger (thumb, index, middle, ring, or little finger). Patients answer "yes" or "no" to numbness.

GroupValue95% CI
Lidocaine55
Bupivacaine58
Post-operative Numbness Secondary · 4 hours post-op

Presence of post-operative numbness in any finger (thumb, index, middle, ring, or little finger). Patients answer "yes" or "no" to numbness.

GroupValue95% CI
Lidocaine55
Bupivacaine64
Post-operative Numbness Secondary · 6 hours post-op

Presence of post-operative numbness in any finger (thumb, index, middle, ring, or little finger). Patients answer "yes" or "no" to numbness.

GroupValue95% CI
Lidocaine43
Bupivacaine63
Post-operative Numbness Secondary · 8 hours post-op

Presence of post-operative numbness in any finger (thumb, index, middle, ring, or little finger). Patients answer "yes" or "no" to numbness.

GroupValue95% CI
Lidocaine31
Bupivacaine59

Sponsor's own description

This study is being conducted to determine whether addition of a longer-acting local anesthetic to our current anesthetic protocol improves the post-operative pain after carpal tunnel release. Participants undergoing carpal tunnel release (CTR) will be randomly assigned to one of two groups: the standard anesthetic or the longer-acting anesthetic. Participants will not be aware of their assignment. Carpal tunnel release will be performed in the standard fashion at our hospital. Participants will record their post-operative pain on a visual scale at 2, 4, 6, 8, and 10 hours after surgery. They will also record the location of their post-operative numbness at the same time intervals. The day after surgery, a research nurse will call each participant to inquire about their post-operative pain scores and numbness. Participants will also be asked about their consumption of oral painkillers (e.g. Tylenol, ibuprofen) during the first 24 hours. Participants will be re-assessed 3 months after surgery to evaluate improvement in carpal tunnel symptoms. Participants who wish to have carpal tunnel release on both wrists will be randomized to receive one type of anesthetic for the first side and will receive the other anesthetic for the second side. They will not be made aware of which medication is used for each side. This will allow us to directly compare the difference in pain experience between the two anesthetics. We hypothesize that use of a longer-acting local anesthetic will lead to decreased post-operative pain, especially in the first 4-8 hours after surgery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Carpal Tunnel Syndrome

Currently open trials in the same condition.

Other University of Saskatchewan trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04833777.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing