Are There Differences in Postoperative Pain Between Bupivacaine and Lidocaine for Carpal Tunnel Release?

August 26, 2023 updated by: IGNACIO RELLAN, Hospital Italiano de Buenos Aires

Which Combination of Local Anesthesia is Superior for Postoperative Pain After Carpal Tunnel Surgery?: A Prospective Randomized Study.

The goal of this clinical trial is to compare the use of bupivacaine and lidocaine as local anesthetics in carpal tunnel release surgery. The main questions it aims to answer are:

  • Are there any differences in pain after surgery?
  • Are there any differences in postoperative analgesic consumption?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Wide-Awake Local Anesthesia No Tourniquet (WALANT) technique has become popular for hand surgery in the past decade. It consists of injecting a local anesthetic and epinephrine into the surgical site. Lidocaine, a short-acting local anesthetic, is used in the classic description. Adding a long-acting local anesthetic, such as bupivacaine, has been suggested for long surgeries.

However, the use of bupivacaine in shorter-duration procedures could combine the advantages of ambulatory surgery without a tourniquet with long-acting analgesia, improving postoperative pain and reducing the consumption of analgesics.

Patients undergoing first-time open carpal tunnel release surgery will be randomized to receive bupivacaine or lidocaine. Randomization will be generated by computer using random block sizes of 2 or 4 with an allocation ratio of 1:1.

Postoperatively, patients will receive standard medical care. It consists of 50 mg of diclofenac to take when they feel pain (with a minimum interval of 8 hours). Patients will be instructed to complete a medication log for pain and analgesic consumption. A blinded investigator will contact them by phone at 24 hours and 48hs. At two weeks, they will be controlled by research staff for complications.

Eighty-two patients will be recruited, 41 per arm, assuming a 20% loss. The sample size was calculated using a 90% power and 5% significance level. The objective was to detect a minimum difference of 2 points on a numeric scale ranging from 0 to 10 with a standard deviation of 2.5 points.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Other
      • Buenos Aires, Other, Argentina, 1199
        • Hospital Italiano de Buenos Aires

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with carpal tunnel syndrome undergoing first-time surgery

Exclusion Criteria:

  • Pregnant
  • End-stage kidney disease
  • End-stage liver disease
  • Allergy to bupivacaine, lidocaine or diclofenac
  • Carpal tunnel revision surgery
  • Associated surgery (e.g., trigger finger release)
  • Unable to understand informed consent or indications
  • Patients with anxiety related to surgery who explicitly prefer to be sedated or asleep during their surgery
  • Preoperative American Society of Anaesthesiology (ASA) scale ≥3

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lidocaine
Patients will receive lidocaine
Drug: Lidocaine
Patients will receive 20 ml of 1% lidocaine with 1:100,000 epinephrine (buffered 10:1 with 8.4% sodium bicarbonate). Thirty minutes before carpal tunnel release surgery, 10 mL will be injected subcutaneously, and 10 mL will be injected into the carpal tunnel.
Experimental: Bupivacaine
Patients will receive bupivacaine
Drug: Bupivacain
Bupivacaine: Patients will receive 10 ml of 0.5% bupivacaine + 10 ml of 1% lidocaine with 1:100,000 epinephrine (buffered 10:1 with 8.4% sodium bicarbonate). Thirty minutes before carpal tunnel release surgery, 10 mL will be injected subcutaneously, and 10 mL will be injected into the carpal tunnel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain
Time Frame: Change in pain at 24 and 48 hours or when the patients take analgesics
Visual analog scale, numerical scale from 0 to 10
Change in pain at 24 and 48 hours or when the patients take analgesics
Time until pain
Time Frame: Until 48 hours from surgery
Time in hours (numeric) from surgery until the patient feel pain
Until 48 hours from surgery
Amount of analgesic
Time Frame: at 24 and 48 hours
The number of analgesics consumed by the patient. Numeric
at 24 and 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain during anesthesia
Time Frame: 1 minute after the injection of local anesthesia
Visual analog scale, numerical scale from 0 to 10
1 minute after the injection of local anesthesia
interruption of sleep due to pain
Time Frame: at 24 hours
Did the patient wake up because of pain the first night?, Categorical, Yes or No
at 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Italiano de Buenos Aires

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2022

Primary Completion (Actual)

August 7, 2023

Study Completion (Actual)

August 26, 2023

Study Registration Dates

First Submitted

December 31, 2022

First Submitted That Met QC Criteria

January 16, 2023

First Posted (Actual)

January 25, 2023

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 26, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6337

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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