Clinical trial NCT03510559: Forearm vs Brachial Plexus Blockade for Routine Hand and Wrist Surgery
Official title: A Comparison of Forearm Versus Brachial Plexus Blockade for Routine Hand and Wrist Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-operative Pain Management
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-04-27
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients scheduled for ambulatory hand surgery will be assessed in the pre-operative assessment clinic at the time of surgical booking for recruitment into the study by their surgeon. A research assistant will then speak with the patient regarding the study in order to obtain informed consent for their participation.

If the patient consents to participate in the study, they will be randomized into either the brachial plexus or forearm nerve block groups. The research assistants will be blinded as to the patient's allocation and during block performance to minimize bias.
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is very common to perform nerve blocks for hand and wrist surgery. It allows the surgeon to perform the surgery and helps with pain control after surgery. This also means only light sedation is needed for the procedure instead of a general anesthetic, which speeds up recovery time.

There are 2 types of nerve blocks that can be done for hand and/or wrist surgery. The one that is done commonly now is where the whole arm is frozen with local anesthetic. Another option is to have a nerve block where only the arm from the elbow down is frozen. Either of these types of nerve blocks can be chosen to safely accomplish surgery of the hand or wrist. However, the best nerve block for hand and/or wrist surgery has not been decided yet.

In order to determine which block is best, the investigators will be looking at patient satisfaction with the experience, as well as the surgical conditions provided and overall safety.

It is thought that many patients may prefer the arm block below the elbow as it allows for greater mobility immediately following surgery, and the surgical conditions provided will be very similar to those of the full arm nerve block.

Detailed description: A randomized controlled trial involving adult patients undergoing surgery to the wrist and hand with centralized random allocation of patients to 2 groups: 1)Brachial plexus block and 2)Forearm block. The brachial plexus group will undergo a standard brachial plexus block. The forearm group will undergo a block of the proximal forearm targeting the radial sensory, ulnar, median and lateral antebrachial cutaneous nerves.

Group allocation will not be blinded from the treating physicians or patients due to methodological constraints. However, the research assistants performing follow-up assessments will be blinded.

Brachial plexus anesthesia provides a reliable sensorimotor block for upper extremity surgery. It is the current gold standard of anesthesia for surgery on the hand. A forearm block is an alternative anesthetic technique. As day surgery for hand procedures is less invasive and has fewer analgesic requirements, it may be that a forearm block, which allows for preservation of upper extremity function, is of benefit for these types of procedures. It is anticipated that patients may appreciate the forearm block as opposed to a brachial plexus block as they will have greater functionality post-operatively upon returning home. This contrasts with a brachial plexus block which causes a flaccid and insensate upper extremity lasting for many hours beyond the surgical procedure longer than the anticipated analgesic requirements which may be detrimental. Conversely, a forearm block may not provide sufficient anesthesia to create a dense motor blockade, which may result in unwanted intra-operative hand movements during surgery. This could pose a significant safety concern.

A forearm block has successfully been used as a primary anesthetic in patients undergoing hand surgery, although no information has been published about patient satisfaction and events related to patient safety.

The investigators aim to assess patient satisfaction, as well as overall efficacy and safety of the forearm blocks for hand and wrist surgery, as compared to the gold standard of brachial plexus blocks.

Eligibility criteria: Inclusion Criteria:

* Consented, English-speaking, adult patients (age \> 18)
* American Society of Anesthesiologists (ASA) classification I-III
* BMI ≤ 38 kg/m2 (quality of US imaging deteriorates significantly with obesity)
* Patients undergoing hand and/or wrist surgery (except wrist arthroscopy)

Exclusion Criteria:

* Previous upper extremity nerve block
* Contra-indication to nerve blocks e.g., infection, bleeding diathesis, allergy to local anesthetics
* Existing chronic pain disorders or history of use of ≥ 30mg morphine or equivalent per day
* Pre-existing neurological deficits or peripheral neuropathy involving the operative upper extremity
* Pregnancy
* Any significant psychiatric conditions that may affect patient assessment
* Inability to tolerate a forearm tourniquet
* Wrist arthroscopy surgery (requires upper arm tourniquet)
* Inability to speak or understand English without an interpreter present

Primary outcomes:
measure: Patient satisfaction with overall block
timeFrame: Study coordinators will assess QoR-15 change between baseline and 24 hours after surgery
Secondary outcomes:
measure: Amount of intraoperative sedation required
timeFrame: 6 hours
measure: Supplemental local anesthetic to block
timeFrame: 2 hours
measure: Supplemental local anesthetic to block in operation room
timeFrame: 6 hours
measure: Time in PACU
timeFrame: 6 hours
measure: Surgical procedure time (minutes)
timeFrame: 6 hours
measure: Block procedure time (minutes)
timeFrame: 2 hours
measure: Analgesia provided by the nerve block
timeFrame: 6 hours
measure: Analgesia provided by the nerve block
timeFrame: 24 hours
measure: Number and severity of safety-events as measured by hand movements recorded intraoperatively
timeFrame: 24 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Ahtsham Niazi, MD
role: PRINCIPAL_INVESTIGATOR
References: