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

April 22, 2019 updated by: Dr Mario Luc, St. Mary's Research Center, Canada

Lidocaine With Epinephrine vs. Bupivacaine With Epinephrine as Local Anesthetic Agents in Wide-awake Hand Surgery: an Outcome Study of Patients' Pain Perception.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1M5
        • St. Mary's Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lidocaine with epinephrine

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.
Procedure: Wrist block anesthesia
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.
Other Names:
  • Lidocaine with epinephrine
  • Bupivacain with epinephrine
Experimental: Bupivacaine with epinephrine

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.
Procedure: Wrist block anesthesia
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.
Other Names:
  • Lidocaine with epinephrine
  • Bupivacain with epinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores on a visual analogue scale
Time Frame: 24 hours
Patients' pain scores on a visual analogue scale over the first 24 hours after surgery.
24 hours
Pattern and amount of analgesics consumed
Time Frame: 48 hours
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.
48 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Mary's Research Center, Canada

Investigators

  • Principal Investigator: Mario Luc, MD, FRCSC, McGill University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

December 3, 2014

First Submitted That Met QC Criteria

December 9, 2014

First Posted (Estimate)

December 12, 2014

Study Record Updates

Last Update Posted (Actual)

April 23, 2019

Last Update Submitted That Met QC Criteria

April 22, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMHC #14-30

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Carpal Tunnel Syndrome

Clinical Trials on Wrist block anesthesia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe