AzTrials
AzTrials

Carpal Tunnel SyndromeNCT05697276

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

A study testing Lidocaine and Bupivacain in people with Carpal Tunnel Syndrome and Carpal Tunnel, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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? Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carpal Tunnel Syndrome, Carpal Tunnel
What is being tested?
Lidocaine and Bupivacain
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteArgentina
Study dates
13 Sep 2022to 26 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with carpal tunnel syndrome undergoing first-time surgery

Who cannot join

  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Argentina1 site

  • Hospital italiano de Buenos Aires

    Buenos Aires, Other, 1199

Other trials in Argentina

About this study

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

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?
Read the 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.

Being tested
Lidocaine, Bupivacain
Keywords
Carpal Tunnel Syndrome, Postoperative Pain, Bupivacaine, WALANT, Lidocaine
Medical subject headings
Carpal Tunnel Syndrome, Median Neuropathy, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LidocaineDrug

    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.

  • BupivacainDrug

    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.

Study groups in NCT05697276
Study groupRoleWhat they receive
LidocaineActive comparatorPatients will receive lidocaine
Receives: Drug: Lidocaine
BupivacaineExperimentalPatients will receive bupivacaine
Receives: Drug: Bupivacain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Pain

    Visual analog scale, numerical scale from 0 to 10

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

  2. Time until pain

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

    Measured: Until 48 hours from surgery

  3. Amount of analgesic

    The number of analgesics consumed by the patient. Numeric

    Measured: at 24 and 48 hours

Secondary outcomes (2)

  1. Pain during anesthesia

    Visual analog scale, numerical scale from 0 to 10

    Measured: 1 minute after the injection of local anesthesia

  2. interruption of sleep due to pain

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

    Measured: at 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2023
  2. Study start13 Sep 2022
  3. Primary completion7 Aug 2023
  4. Study completion26 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05697276
Sponsor's protocol ID
6337
Status last verified
Aug 2023
First submitted
31 Dec 2022
Last updated
29 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 23908250

  • 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.

    PubMed 21042120

  • 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.

    PubMed 24286736

  • 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.

    PubMed 23413849

  • 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.

    PubMed 35415474

  • Rellan I, De Carli P, Bronenberg Victorica P, Holc F, Donndorff AG, Martinez EF, Abrego MO, Gallucci G, Boretto JG. Does addition of a bupivacaine improve postoperative pain after carpal tunnel release in WALANT? A prospective randomized trial. J Hand Microsurg. 2026 Apr 27;18(4):100467. doi: 10.1016/j.jham.2026.100467. eCollection 2026 Jul.

    PubMed 42100467

Questions about this trial

What is this clinical trial studying?

A study testing Lidocaine and Bupivacain in people with Carpal Tunnel Syndrome and Carpal Tunnel, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Pain (time frame: Change in pain at 24 and 48 hours or when the patients take analgesics). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05697276, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in