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OpenTrials
Completed

NCT Number: NCT05697276

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

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?

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital italiano de Buenos Aires

Buenos Aires, Other, 1199, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Postoperative Pain

    Time frame: Change in pain at 24 and 48 hours or when the patients take analgesics

    Visual analog scale, numerical scale from 0 to 10

  2. Time until pain

    Time frame: Until 48 hours from surgery

    Time in hours (numeric) from surgery until the patient feel pain

  3. Amount of analgesic

    Time frame: at 24 and 48 hours

    The number of analgesics consumed by the patient. Numeric

Secondary outcomes

  1. Pain during anesthesia

    Time frame: 1 minute after the injection of local anesthesia

    Visual analog scale, numerical scale from 0 to 10

  2. interruption of sleep due to pain

    Time frame: at 24 hours

    Did the patient wake up because of pain the first night?, Categorical, Yes or No

Sponsors and collaborators

Lead sponsor

Hospital Italiano de Buenos Aires

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 25, 2023
Registry last updated
Aug 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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