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

Sponsor

Hospital Italiano de Buenos Aires (Other)

Overall Status

Recruiting

CT.gov ID

NCT05697276

Collaborator

(none)

Enrollment

Location

Arms

5.6

Anticipated Duration (Months)

14.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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?

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel Syndrome Carpal Tunnel	Drug: Lidocaine Drug: Bupivacain	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

82 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 13, 2022

Actual Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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