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

NCT04833777 | Completed Results

• 1 other identifier: Bio2640
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carpal Tunnel Syndrome

Keywords

lidocaine; bupivacaine; carpal tunnel release

Outcome Measures

Primary Outcomes (8)

• Post-operative Pain

  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.

  2 hours post-op

• Post-operative Pain

  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.

  4 hours post-op

• Post-operative Pain

  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.

  6 hours post-op

• Post-operative Pain

  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.

  8 hours post-op

• Post-operative Pain

  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.

  10 hours post-op

• Post-operative Pain

  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.

  24 hours post-op

• Post-operative Analgesia Requirements

  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.

  24 hours

• Post-operative Analgesia Requirements

  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.

  72 hours

Secondary Outcomes (9)

• Post-operative Numbness

  2 hours post-op

• Post-operative Numbness

  4 hours post-op

• Post-operative Numbness

  6 hours post-op

• Post-operative Numbness

  8 hours post-op

• Post-operative Numbness

  10 hours post-op

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

Administration of subcutaneous lidocaine as local anesthetic prior to carpal tunnel release (lidocaine intervention)

Drug: Local Anesthetics Lidocaine

Bupivacaine

EXPERIMENTAL

Administration of subcutaneous bupivacaine + lidocaine as local anesthetic prior to carpal tunnel release (bupivacaine intervention)

Drug: Local Anesthetics Bupivacaine

Interventions

Local Anesthetics Lidocaine DRUG

10 mL 1% lidocaine with 1:100,000 epinephrine and 1 mL 8.4% sodium bicarbonate

Lidocaine

Local Anesthetics Bupivacaine DRUG

5 mL 1% lidocaine with 1:100,000 epinephrine + 5 mL 0.5% bupivacaine with 1:100,000 epinephrine and 1 mL 8.4% sodium bicarbonate

Bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged \>18 years undergoing carpal tunnel release

You may not qualify if:

• Patients aged \<18 years
• Patients undergoing repeat carpal tunnel release
• Patients undergoing simultaneous procedures for other hand/wrist pathology at the time of carpal tunnel release (i.e. trigger finger release, Dupuytren's, etc.)
• Patients with a history of Rheumatoid Arthritis or a history or previous trauma or surgery to the local area (i.e. distal radius fracture)
• Patients who lack the capacity to provide informed consent or understand the nature of the project

Sponsors & Collaborators

• University of Saskatchewan: lead
• Saskatoon City Hospital: collaborator

Study Sites (1)

Saskatoon City Hospital

Saskatoon, Saskatchewan, S7K 0M7, Canada

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Lidocaine, Prilocaine Drug Combination; Bupivacaine

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

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. David Sauder
• Organization: University of Saskatchewan

sauderdave@gmail.com

306-955-9800

Study Officials

• David Sauder, MD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The surgeon administering the local anesthetic will not be blinded, however the participant and the research nurse (measuring outcomes) will be.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, orthopedic surgeon

Model Details: The study model for the primary outcome will be single group (patients randomized to one of two anesthetic types). However, select patients who wish to have bilateral carpal tunnel release will be entered into a crossover model, such that they will be randomized for their first surgery and receive the other type of anesthetic for their second surgery.

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 6, 2021
• Study Start: July 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)