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Forearm vs Brachial Plexus Blockade for Routine Hand and Wrist Surgery

Primary Purpose

Post-operative Pain Management

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Forearm Nerve Block
Brachial Plexus Block
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post-operative Pain Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toronto Western HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Brachial Plexus Block

Forearm Nerve Block

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Amount of intraoperative sedation required
Intraoperative sedation required by the surgical time in minutes ( from operation room arrival to discharge) for varying surgical durations
Supplemental local anesthetic to block
Requirement for additional local anesthetic in the block room from the block room arrival to discharge
Supplemental local anesthetic to block in operation room
Requirement for additional local anesthetic intraoperatively (mL) from operation room arrival to discharge
Time in PACU
Time spent in the post-operative anesthetic care unit measured in minutes from moment of PACU arrival to discharge
Surgical procedure time (minutes)
Time spent completing the surgical procedure measured in minutes from time of incision until time of surgical dressing application
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
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.
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
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

Full Information

First Posted
March 6, 2018
Last Updated
September 25, 2019
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03510559
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2018 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
August 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain Management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brachial Plexus Block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Forearm Nerve Block
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Forearm Nerve Block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Brachial Plexus Block
Other Intervention Name(s)
Bracial Plexus Nerve Block
Intervention Description
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 Information:
Title
Patient satisfaction with overall block
Description
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.
Time Frame
Study coordinators will assess QoR-15 change between baseline and 24 hours after surgery
Secondary Outcome Measure Information:
Title
Amount of intraoperative sedation required
Description
Intraoperative sedation required by the surgical time in minutes ( from operation room arrival to discharge) for varying surgical durations
Time Frame
6 hours
Title
Supplemental local anesthetic to block
Description
Requirement for additional local anesthetic in the block room from the block room arrival to discharge
Time Frame
2 hours
Title
Supplemental local anesthetic to block in operation room
Description
Requirement for additional local anesthetic intraoperatively (mL) from operation room arrival to discharge
Time Frame
6 hours
Title
Time in PACU
Description
Time spent in the post-operative anesthetic care unit measured in minutes from moment of PACU arrival to discharge
Time Frame
6 hours
Title
Surgical procedure time (minutes)
Description
Time spent completing the surgical procedure measured in minutes from time of incision until time of surgical dressing application
Time Frame
6 hours
Title
Block procedure time (minutes)
Description
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
Time Frame
2 hours
Title
Analgesia provided by the nerve block
Description
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.
Time Frame
6 hours
Title
Analgesia provided by the nerve block
Description
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
Time Frame
24 hours
Title
Number and severity of safety-events as measured by hand movements recorded intraoperatively
Description
Assessing number and severity of intraoperative hand movements from time of incision until time of surgical dressing application
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rongyu Jin, MD
Phone
416-603-5800
Ext
3943
Email
Rongyu.Jin@uhn.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Tierney, MD
Email
sarah.tierney@one-mail.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahtsham Niazi, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongyu Jin
Phone
416-603-5800
Ext
2016
Email
rongyu.jin@uhn.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Forearm vs Brachial Plexus Blockade for Routine Hand and Wrist Surgery

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