Recruiting

Forearm vs. Brachial Plexus

Sponsor:

University Health Network, Toronto

Code:

NCT03510559

Conditions

Post-operative Pain Management

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Forearm Nerve Block

Brachial Plexus Block

Study Details

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

Study ID

NCT03510559

Start date

Apr 30, 2018

Status verified date

Sep, 2019

Completion date

Aug 1, 2020

Anticipated

Primary completion date

Jun 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Brachial Plexus Block

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.

experimental: Forearm Nerve Block

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.

Interventions

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.

Primary outcome measure

  • Patient satisfaction with overall block [ Time Frame: Study coordinators will assess QoR-15 change between baseline and 24 hours after surgery ]

Central Contacts and Locations

Central contacts

Rongyu Jin, MD

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

Sarah Tierney, MD

sarah.tierney@one-mail.on.ca

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Rongyu Jin

416-603-5800rongyu.jin@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Sep 27, 2019

Last verified

Sep, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2019-09-27.