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Lidocaine With Epinephrine vs. Bupivacaine With Epinephrine as Local Anesthetic Agents in Wide-awake Hand Surgery

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Wrist block anesthesia
Sponsored by
St. Mary's Research Center, Canada
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, Anesthetics, Local, Pain Perception, Pain Measurement, Analgesia, Lidocaine, Bupivacaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Over 18 years old
  • First time carpal tunnel surgery

Exclusion Criteria:

  • Regular analgesic medication consumption
  • More than one surgical procedure at the same time as carpal tunnel surgery
  • Need for a surrogate decision maker
  • Allergic or unable to take morphine, hydromorphone (Dilaudid), acetaminophen (Tylenol), lidoxaine (Xylocaine), bupivacaine (Marcane), or epinephrine
  • End stage kidney disease
  • End stage liver disease
  • Pregnant

Sites / Locations

  • St. Mary's Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lidocaine with epinephrine

Bupivacaine with epinephrine

Arm Description

Wrist block anesthesia with Lidocaine 1% with epinephrine; 10cc. Group 1 will receive the same treatment as group 2, except that the wide-awake carpal tunnel release surgery will be performed under Lidocaine anesthesia instead of Bupivacaine anesthesia.

Wrist block anesthesia with Bupivacaine 0.25% with epinephrine; 10cc. Group 2 will receive the same treatment as group 1, except that the wide-awake carpal tunnel release surgery will be performed under Bupivacaine anesthesia instead of Lidocaine anesthesia.

Outcomes

Primary Outcome Measures

Pain scores on a visual analogue scale
Patients' pain scores on a visual analogue scale over the first 24 hours after surgery.
Pattern and amount of analgesics consumed
The time of consumption and the type of analgesic (acetaminophen 1g PO q6hr PRN or morphine 5mg PO q4hr PRN) consumed over the first 48 hours after surgery. This will be recorded in the medication log given to patients.

Secondary Outcome Measures

Pain scores on a visual analogue scale
Patients' pain scores on a visual analogue scale perceived between the first 24 hours and 48 hours after surgery.
Patient satisfaction scores on a visual analogue scale
Patient self rated satisfaction on a visual analogue scale with wide-awake carpal tunnel release surgery. Will be measured immediately after surgery.

Full Information

First Posted
December 3, 2014
Last Updated
April 22, 2019
Sponsor
St. Mary's Research Center, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02315573
Brief Title
Lidocaine With Epinephrine vs. Bupivacaine With Epinephrine as Local Anesthetic Agents in Wide-awake Hand Surgery
Official Title
Lidocaine With Epinephrine vs. Bupivacaine With Epinephrine as Local Anesthetic Agents in Wide-awake Hand Surgery: an Outcome Study of Patients' Pain Perception.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Mary's Research Center, Canada

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is focused on comparing patients' pain scores on a visual analogue scale (VAS) and the difference in analgesics use post-operatively (with the same prescription defining only the maximum frequency) between lidocaine with epinephrine & bupivacaine with epinephrine as local anesthetics in wide-awake hand surgery. The investigators' hypothesis states that a longer acting local anesthetic agent (bupivacaine) would be able to provide better postoperative pain relief demonstrated by lower pain scores on VAS and less analgesics use (as will be recorded on the patient's log). This will be mainly obvious in the first 24 hours postoperative period when the pain is usually at maximum levels and starts to decline thereafter. If the investigators' hypothesis is true, this may potentially change practices of many hand surgeons towards the routine use of longer acting local anesthetics particularly in wide-awake hand surgery, and perhaps could be extrapolated to other surgical specialties. Further, a reduction in postoperative analgesics use would be of paramount clinical importance, as it would reduce their potential side effects.
Detailed Description
The purpose of this study is to better understand the differences of two commonly used local anesthetics in carpal tunnel surgery. This study will explore the differences in terms of patient satisfaction during surgery (measured on VAS), pain after surgery (measured on VAS), and the need for pain medications after surgery (patients will annotate on a log given to them the time of the medication taken if needed for analgesia). Wide awake hand surgery (freezing your limb while being fully awake) has recently been popularized as being faster and safer for patients compared to hand surgery under general anesthesia or with sedation. Advantages include fast recovery and no risks of general anesthesia. In order to freeze the wrist to undergo carpal tunnel surgery, a local anesthetic is injected into the nerves of the wrist. Among the most commonly used anesthetic agents are Lidocaine (shorter duration of anesthesia) and Bupivacaine (longer duration of anesthesia). Until now, no enough evidence to support using one anesthetic agent over the other. Furthermore, no previous studies looked at the perception of pain from patient's perspectives when using different anesthetic agents. There will be NO change in the standard medical care that patients will receive whether or not patients decide to participate in the study. Patients that join the study will receive the same anesthetic agents used in those procedures as patients who decide not to participate. The only difference will be collecting clinical data from participants and asking participants to complete two questionnaires regarding the surgical experience, and the perceived level of pain during the two days that follow surgery. As well, participants will be asked to keep a simple log of the pain medications that are consumed during the two days after the surgery. Patients' total participation time should take no more than 30 minutes. Patients' decision to participate in this study will help doctors in the future to decide which of these two used anesthetic agents (Lidocaine or Bupivacaine) gives patients the best experience during surgery. As well, it will help reduce the pain that some patients experience after surgery, as well as reduce the need for pain medications after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Carpal Tunnel Syndrome, Anesthetics, Local, Pain Perception, Pain Measurement, Analgesia, Lidocaine, Bupivacaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine with epinephrine
Arm Type
Experimental
Arm Description
Wrist block anesthesia with Lidocaine 1% with epinephrine; 10cc. Group 1 will receive the same treatment as group 2, except that the wide-awake carpal tunnel release surgery will be performed under Lidocaine anesthesia instead of Bupivacaine anesthesia.
Arm Title
Bupivacaine with epinephrine
Arm Type
Experimental
Arm Description
Wrist block anesthesia with Bupivacaine 0.25% with epinephrine; 10cc. Group 2 will receive the same treatment as group 1, except that the wide-awake carpal tunnel release surgery will be performed under Bupivacaine anesthesia instead of Lidocaine anesthesia.
Intervention Type
Procedure
Intervention Name(s)
Wrist block anesthesia
Other Intervention Name(s)
Lidocaine with epinephrine, Bupivacain with epinephrine
Intervention Description
The carpal tunnel release surgery will be performed under wrist block anesthesia. Group 1 will have the wrist block performed with Lidocaine and epinephrine, while Group 2 with Bupivacaine and epinephrine.
Primary Outcome Measure Information:
Title
Pain scores on a visual analogue scale
Description
Patients' pain scores on a visual analogue scale over the first 24 hours after surgery.
Time Frame
24 hours
Title
Pattern and amount of analgesics consumed
Description
The time of consumption and the type of analgesic (acetaminophen 1g PO q6hr PRN or morphine 5mg PO q4hr PRN) consumed over the first 48 hours after surgery. This will be recorded in the medication log given to patients.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Pain scores on a visual analogue scale
Description
Patients' pain scores on a visual analogue scale perceived between the first 24 hours and 48 hours after surgery.
Time Frame
24 hours
Title
Patient satisfaction scores on a visual analogue scale
Description
Patient self rated satisfaction on a visual analogue scale with wide-awake carpal tunnel release surgery. Will be measured immediately after surgery.
Time Frame
Immediate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Over 18 years old First time carpal tunnel surgery Exclusion Criteria: Regular analgesic medication consumption More than one surgical procedure at the same time as carpal tunnel surgery Need for a surrogate decision maker Allergic or unable to take morphine, hydromorphone (Dilaudid), acetaminophen (Tylenol), lidoxaine (Xylocaine), bupivacaine (Marcane), or epinephrine End stage kidney disease End stage liver disease Pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Luc, MD, FRCSC
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Mary's Hospital Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1M5
Country
Canada

12. IPD Sharing Statement

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Lidocaine With Epinephrine vs. Bupivacaine With Epinephrine as Local Anesthetic Agents in Wide-awake Hand Surgery

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