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

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ClinicalTrials.gov Identifier: NCT02315573
Recruitment Status : Completed
First Posted : December 12, 2014
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Mario Luc, St. Mary's Research Center, Canada

Tracking Information
First Submitted Date  ICMJE December 3, 2014
First Posted Date  ICMJE December 12, 2014
Last Update Posted Date April 23, 2019
Study Start Date  ICMJE October 2014
Actual Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2014)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02315573 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2014)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lidocaine With Epinephrine vs. Bupivacaine With Epinephrine as Local Anesthetic Agents in Wide-awake Hand Surgery
Official Title  ICMJE Lidocaine With Epinephrine vs. Bupivacaine With Epinephrine as Local Anesthetic Agents in Wide-awake Hand Surgery: an Outcome Study of Patients' Pain Perception.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Carpal Tunnel Syndrome
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.

    Intervention: Procedure: Wrist block anesthesia
  • 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.

    Intervention: Procedure: Wrist block anesthesia
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2019)
61
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2014)
70
Actual Study Completion Date  ICMJE April 2019
Actual Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02315573
Other Study ID Numbers  ICMJE SMHC #14-30
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Mario Luc, St. Mary's Research Center, Canada
Study Sponsor  ICMJE St. Mary's Research Center, Canada
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mario Luc, MD, FRCSC McGill University
PRS Account St. Mary's Research Center, Canada
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP