Forearm vs Brachial Plexus Blockade for Routine Hand and Wrist Surgery

NCT03510559 | Unknown

• 1 other identifier: 17-6152-A
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Pain Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Amount of intraoperative sedation required

  6 hours

• Supplemental local anesthetic to block

  2 hours

• Supplemental local anesthetic to block in operation room

  6 hours

• Time in PACU

  6 hours

• Surgical procedure time (minutes)

  6 hours

Study Arms (2)

Brachial Plexus Block

ACTIVE COMPARATOR

It will be at the discretion of the anesthesiologist performing the block to choose a supraclavicular, infraclavicular or axillary block to achieve adequate surgical anesthesia of the operative arm. After sterile skin preparation with chlorhexidine, a linear array transducer probe is placed on the skin and the appropriate nerve structures are identified. Local anesthetics (30 mL of 50:50 mix of 0.5% bupivacaine and 2% lidocaine) will then be injected in 5 mL aliquots after negative aspiration for blood to achieve circumferential spread around the brachial plexus. Patients who have a failed brachial plexus block may undergo a rescue forearm block, and will be recorded as requiring supplemental local anesthetic.

Drug: Brachial Plexus Block

Forearm Nerve Block

EXPERIMENTAL

Patients allocated to the forearm block will have it performed in the semi-setting position. After sterile skin preparation with chlorhexidine and infiltration with 1 mL of 1% lidocaine, a linear array transducer probe is placed at the distal forearm to visualize each peripheral nerve (radial, ulnar, median, and lateral antebrachial cutaneous). A 5 cm 22 G insulated needle is then used to target each nerve individually and infiltrate 7.5mL of the 50:50 mixture (similar to the brachial plexus block group) at each nerve to a total of 30mL.

Drug: Forearm Nerve Block

Interventions

Forearm Nerve Block DRUG

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.

Forearm Nerve Block

Brachial Plexus Block DRUG

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.

Also known as: Bracial Plexus Nerve Block

Brachial Plexus Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Interventions

Brachial Plexus Block

Intervention Hierarchy (Ancestors)

Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Ahtsham Niazi, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rongyu Jin, MD

CONTACT

416-603-5800; Rongyu.Jin@uhn.ca

Sarah Tierney, MD

CONTACT

sarah.tierney@one-mail.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research assistants who will be performing the follow-up assessments of the patient will be blinded as to block group allocation. No other members of the team will be blinded for this study due to methodological constraints as the end result of these blocks is very different due to upper arm weakness expected with brachial plexus blocks, but not with forearm blocks.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: April 27, 2018
• Study Start: April 30, 2018
• Primary Completion: June 1, 2020
• Study Completion: August 1, 2020
• Last Updated: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)