Forearm vs Brachial Plexus Blockade for Routine Hand and Wrist Surgery

Post-operative Pain Management Clinical Trial

Official title:

A Comparison of Forearm Versus Brachial Plexus Blockade for Routine Hand and Wrist Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03510559
• Other study ID #: 17-6152-A
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2018
• Est. completion date: August 1, 2020

Study information

• Verified date: September 2019
• Source: University Health Network, Toronto
• Contact: Rongyu Jin, MD
• Phone: 416-603-5800
• Email: Rongyu.Jin[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: August 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain Management

Intervention

Drug:
• Forearm Nerve Block
Blockade of the arm below the elbow using local anesthetic (0.5% bupivacaine and 2% lidocaine) deposited under ultrasound guidance to facilitate performance of the surgical procedure.
• Brachial Plexus Block
Blockade of the entire arm using local anesthetic (0.5% bupivacaine and 2% lidocaine) deposited under ultrasound guidance to facilitate performance of the surgical procedure.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction with overall block	The impact of surgical and anesthetic interventions on perioperative quality of life will be assessed using the QoR-15 tool (Quality of Recovery -15). The QoR-15 is a patient-based outcome measure in the form of a 15-item validated questionnaire.	Study coordinators will assess QoR-15 change between baseline and 24 hours after surgery
Secondary	Amount of intraoperative sedation required	Intraoperative sedation required by the surgical time in minutes ( from operation room arrival to discharge) for varying surgical durations	6 hours
Secondary	Supplemental local anesthetic to block	Requirement for additional local anesthetic in the block room from the block room arrival to discharge	2 hours
Secondary	Supplemental local anesthetic to block in operation room	Requirement for additional local anesthetic intraoperatively (mL) from operation room arrival to discharge	6 hours
Secondary	Time in PACU	Time spent in the post-operative anesthetic care unit measured in minutes from moment of PACU arrival to discharge	6 hours
Secondary	Surgical procedure time (minutes)	Time spent completing the surgical procedure measured in minutes from time of incision until time of surgical dressing application	6 hours
Secondary	Block procedure time (minutes)	Time spent completing the nerve block measured in minutes from time of initial ultrasound probe contact with skin until removal of needle at block completion	2 hours
Secondary	Analgesia provided by the nerve block	Postoperative pain severity at rest will be assessed using a numerical rating scale (NRS; 0=no pain, 10=worst pain imaginable) score during the post-anesthesia care unit (PACU) stay.	6 hours
Secondary	Analgesia provided by the nerve block	Postoperative pain severity at rest will be assessed using a numerical rating scale (NRS; 0=no pain, 10=worst pain imaginable) score at 24 hours post-op. Cumulative oral analgesic consumption since hospital discharge will also be measured at this time	24 hours
Secondary	Number and severity of safety-events as measured by hand movements recorded intraoperatively	Assessing number and severity of intraoperative hand movements from time of incision until time of surgical dressing application	24 hours