Carpal Tunnel Syndrome Clinical Trial
Official title:
Which Combination of Local Anesthesia is Superior for Postoperative Pain After Carpal Tunnel Surgery?: A Prospective Randomized Study.
NCT number | NCT05697276 |
Other study ID # | 6337 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 13, 2022 |
Est. completion date | August 26, 2023 |
Verified date | August 2023 |
Source | Hospital Italiano de Buenos Aires |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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?
Status | Completed |
Enrollment | 82 |
Est. completion date | August 26, 2023 |
Est. primary completion date | August 7, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital italiano de Buenos Aires | Buenos Aires | Other |
Lead Sponsor | Collaborator |
---|---|
Hospital Italiano de Buenos Aires |
Argentina,
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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Time until pain | Time in hours (numeric) from surgery until the patient feel pain | Until 48 hours from surgery | |
Primary | Amount of analgesic | The number of analgesics consumed by the patient. Numeric | at 24 and 48 hours | |
Secondary | Pain during anesthesia | Visual analog scale, numerical scale from 0 to 10 | 1 minute after the injection of local anesthesia | |
Secondary | interruption of sleep due to pain | Did the patient wake up because of pain the first night?, Categorical, Yes or No | at 24 hours |
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