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

NCT05697276 | Completed

• 1 other identifier: 6337
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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?

Conditions

Carpal Tunnel Syndrome; Carpal Tunnel

Keywords

Carpal Tunnel Syndrome; Postoperative Pain; Bupivacaine; WALANT; Lidocaine

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Pain during anesthesia

  1 minute after the injection of local anesthesia

• interruption of sleep due to pain

  at 24 hours

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

Patients will receive lidocaine

Drug: Lidocaine

Bupivacaine

EXPERIMENTAL

Patients will receive bupivacaine

Drug: Bupivacain

Interventions

Lidocaine 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.

Lidocaine

Bupivacain 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.

Bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with carpal tunnel syndrome undergoing first-time surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital italiano de Buenos Aires

Buenos Aires, Other, 1199, Argentina

Location

Related Publications (5)

• 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.

  PMID: 23908250 BACKGROUND

• 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.

  PMID: 21042120 BACKGROUND

• 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.

  PMID: 24286736 BACKGROUND

• 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.

  PMID: 23413849 BACKGROUND

• 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.

  PMID: 35415474 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Median Neuropathy; Pain, Postoperative

Interventions

Lidocaine; Bupivacaine

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 31, 2022
• First Posted: January 25, 2023
• Study Start: September 13, 2022
• Primary Completion: August 7, 2023
• Study Completion: August 26, 2023
• Last Updated: August 29, 2023

Record last verified: 2023-08

Locations

AR (1)