Clinical trial NCT02315573: 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
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal Tunnel Syndrome
Anesthetics, Local
Pain Perception
Pain Measurement
Analgesia
Lidocaine
Bupivacaine
Lead sponsor: St. Mary's Research Center, Canada
Sponsor class: OTHER
First posted: 2014-12-12
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain scores on a visual analogue scale
timeFrame: 24 hours
measure: Pattern and amount of analgesics consumed
timeFrame: 48 hours
Secondary outcomes:
measure: Pain scores on a visual analogue scale
timeFrame: 24 hours
measure: Patient satisfaction scores on a visual analogue scale
timeFrame: Immediate
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: St. Mary's Hospital Center
state: Quebec
Study officials:
affiliation: McGill University
name: Mario Luc, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
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