Carpal Tunnel, Carpal Tunnel Syndrome
Conditions
Keywords
Carpal Tunnel Syndrome, Postoperative Pain, Bupivacaine, WALANT, Lidocaine
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?
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.
Interventions
DRUGLidocaine
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.
DRUGBupivacain
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.
Sponsors
Hospital Italiano de Buenos Aires
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Argentina
Outcome results
None listed