Lidocaine With Epinephrine vs. Bupivacaine With Epinephrine as Local Anesthetic Agents in Wide-awake Hand Surgery
Information source: St. Mary's Research Center, Canada
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Carpal Tunnel Syndrome
Intervention: Wrist block anesthesia (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: Dr Mario Luc Official(s) and/or principal investigator(s): Mario Luc, MD, FRCSC, Principal Investigator, Affiliation: Surgeon
Overall contact: Salah Aldekhayel, MD, Phone: 514-230-9541, Email: salah.aldekhayel@mail.mcgill.ca
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Primary outcome: Pain scores on a visual analogue scalePattern and amount of analgesics consumed
Secondary outcome: Pain scores on a visual analogue scalePatient satisfaction scores on a visual analogue scale
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Salah Aldekhayel, MD, Phone: 514-230-9541, Email: salah.aldekhayel@mail.mcgill.ca
St. Mary's Hospital Center, Montreal, Quebec H3T 1M5, Canada; Recruiting Salah Aldekhayel, MD, Phone: 514-406-3840, Email: salah.aldekhayel@mail.mcgill.ca
Additional Information
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Starting date: October 2014
Last updated: December 9, 2014
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