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

Study Overview
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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?

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.

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

Conditions
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Carpal Tunnel Syndrome, Carpal Tunnel

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Bupivacain


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine<br>Patients will receive lidocaine | Drug: Lidocaine<br>* 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.<br>|
| Experimental: Bupivacaine<br>Patients will receive bupivacaine | Drug: Bupivacain<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain | 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 in hours (numeric) from surgery until the patient feel pain | Until 48 hours from surgery | 
| Amount of analgesic | 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 | Visual analog scale, numerical scale from 0 to 10 | 1 minute after the injection of local anesthesia | 
| interruption of sleep due to pain | Did the patient wake up because of pain the first night?, Categorical, Yes or No | at 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carpal Tunnel Syndrome, Postoperative Pain, Bupivacaine, WALANT, Lidocaine