Clinical trial NCT05697276: Are There Differences in Postoperative Pain Between Bupivacaine and Lidocaine for Carpal Tunnel Release?
Official title: Which Combination of Local Anesthesia is Superior for Postoperative Pain After Carpal Tunnel Surgery?: A Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Carpal Tunnel
Keywords: Carpal Tunnel Syndrome
Postoperative Pain
Bupivacaine
WALANT
Lidocaine
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Pain
timeFrame: Change in pain at 24 and 48 hours or when the patients take analgesics
measure: Time until pain
timeFrame: Until 48 hours from surgery
measure: Amount of analgesic
timeFrame: at 24 and 48 hours
Secondary outcomes:
measure: Pain during anesthesia
timeFrame: 1 minute after the injection of local anesthesia
measure: interruption of sleep due to pain
timeFrame: at 24 hours
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital italiano de Buenos Aires
state: Other
Study officials:
References:
citation: Lalonde D, Martin A. Epinephrine in local anesthesia in finger and hand surgery: the case for wide-awake anesthesia. J Am Acad Orthop Surg. 2013 Aug;21(8):443-7. doi: 10.5435/JAAOS-21-08-443.
citation: Lalonde DH. "Hole-in-one" local anesthesia for wide-awake carpal tunnel surgery. Plast Reconstr Surg. 2010 Nov;126(5):1642-1644. doi: 10.1097/PRS.0b013e3181f1c0ef. No abstract available.
citation: Lalonde D. Minimally invasive anesthesia in wide awake hand surgery. Hand Clin. 2014 Feb;30(1):1-6. doi: 10.1016/j.hcl.2013.08.015. Epub 2013 Nov 9.
citation: Chan ZH, Balakrishnan V, McDonald A. Short versus long-acting local anaesthetic in open carpal tunnel release: which provides better preemptive analgesia in the first 24 hours? Hand Surg. 2013;18(1):45-7. doi: 10.1142/S0218810413500081.
citation: Diaz-Abele J, Luc M, Dyachenko A, Aldekhayel S, Ciampi A, McCusker J. Lidocaine With Epinephrine Versus Bupivacaine With Epinephrine as Local Anesthetic Agents in Wide-Awake Hand Surgery: A Pilot Outcome Study of Patient's Pain Perception. J Hand Surg Glob Online. 2019 Oct 31;2(1):1-6. doi: 10.1016/j.jhsg.2019.09.004. eCollection 2020 Jan.