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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-13

Study Completion Date

2023-08-26

Brief Summary

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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?

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Detailed Description

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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.

Conditions

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Carpal Tunnel Syndrome Carpal Tunnel

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Lidocaine

Patients will receive lidocaine

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

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.

Bupivacaine

Patients will receive bupivacaine

Group Type EXPERIMENTAL

Bupivacain

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No