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

Primary Purpose

Carpal Tunnel Syndrome, Carpal Tunnel

Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Lidocaine
Bupivacain
Sponsored by
Hospital Italiano de Buenos Aires
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal Tunnel Syndrome, Postoperative Pain, Bupivacaine, WALANT, Lidocaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital italiano de Buenos Aires

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Lidocaine

Bupivacaine

Arm Description

Patients will receive lidocaine

Patients will receive bupivacaine

Outcomes

Primary Outcome Measures

Postoperative Pain
Visual analog scale, numerical scale from 0 to 10
Time until pain
Time in hours (numeric) from surgery until the patient feel pain
Amount of analgesic
The number of analgesics consumed by the patient. Numeric

Secondary Outcome Measures

Pain during anesthesia
Visual analog scale, numerical scale from 0 to 10
interruption of sleep due to pain
Did the patient wake up because of pain the first night?, Categorical, Yes or No

Full Information

First Posted
December 31, 2022
Last Updated
August 26, 2023
Sponsor
Hospital Italiano de Buenos Aires
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1. Study Identification

Unique Protocol Identification Number
NCT05697276
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 13, 2022 (Actual)
Primary Completion Date
August 7, 2023 (Actual)
Study Completion Date
August 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Italiano de Buenos Aires

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Carpal Tunnel
Keywords
Carpal Tunnel Syndrome, Postoperative Pain, Bupivacaine, WALANT, Lidocaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
Patients will receive lidocaine
Arm Title
Bupivacaine
Arm Type
Experimental
Arm Description
Patients will receive bupivacaine
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacain
Intervention Description
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 Outcome Measure Information:
Title
Postoperative Pain
Description
Visual analog scale, numerical scale from 0 to 10
Time Frame
Change in pain at 24 and 48 hours or when the patients take analgesics
Title
Time until pain
Description
Time in hours (numeric) from surgery until the patient feel pain
Time Frame
Until 48 hours from surgery
Title
Amount of analgesic
Description
The number of analgesics consumed by the patient. Numeric
Time Frame
at 24 and 48 hours
Secondary Outcome Measure Information:
Title
Pain during anesthesia
Description
Visual analog scale, numerical scale from 0 to 10
Time Frame
1 minute after the injection of local anesthesia
Title
interruption of sleep due to pain
Description
Did the patient wake up because of pain the first night?, Categorical, Yes or No
Time Frame
at 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hospital italiano de Buenos Aires
City
Buenos Aires
State/Province
Other
ZIP/Postal Code
1199
Country
Argentina

12. IPD Sharing Statement

Citations:
PubMed Identifier
23908250
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.
Results Reference
background
PubMed Identifier
21042120
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.
Results Reference
background
PubMed Identifier
24286736
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.
Results Reference
background
PubMed Identifier
23413849
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.
Results Reference
background
PubMed Identifier
35415474
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.
Results Reference
background

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

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