Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05325372 |
Other study ID # |
MS-529-2021 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 15, 2022 |
Est. completion date |
April 26, 2023 |
Study information
Verified date |
April 2023 |
Source |
Kasr El Aini Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Hand Surgery is surgery of the hand, the wrist, and the peripheral nerves of the upper limb.
Many different types of surgeries can be performed on the hand, depending on the underlying
cause of the problem such as Closed reduction and fixation, Tendon repair, Skin grafts, Skin
flaps, Carpal Tunnel Release, and ganglion removal. Hand surgery is usually associated with
marked postoperative pain. Ultrasound-guided regional anesthesia is usually performed in
patients undergoing hand surgery.
This study aims to compare Ultrasound-guided infraclavicular block and axillary block and
assess the degree of motor power and duration by testing hand grip strength using a hydraulic
hand dynamometer in patients undergoing hand surgery.
Objectives:
To determine the degree of a motor block using a hydraulic hand dynamometer. To Estimate time
needed to regain full motor activity. To identify whether ultrasound-guided axillary block
may preserve motor function to a greater extent than infraclavicular blocks.
Description:
This randomized control trial is designed to include (52) patients ASA physical status I, II
patients ranging from(18) to(60)years old scheduled for hand surgery
Patients meeting the inclusion criteria will be randomly assigned to receive either:
Group I: axillary block technique (n=26) (group A) GroupII: infraclavicular block technique(
n=26)(group B) Anesthesia management After arrival to the anesthetic room, An 18-gauge
intravenous cannula will be placed at the forearm contralateral to the operated arm, standard
monitoring will be used (non-invasive arterial blood pressure, ECG, pulse oximetry) while
performing the block and throughout the surgical procedure. Premedication will be given
intravenously in the form of 0.03 mg/kg midazolam. 1 g paracetamol iv will be given for all
patients Under aseptic conditions, a preliminary scan will be performed using siemens acuson
x 300 ultrasound with 8-14 MHz linear transducer. A 50-mm block needle 22 gauge will be used.
(SonoPlex Stim Cannula, Germany) All blocks will be given by one researcher using 20 ml of
drug 0.25% bupivacaine (10 ml 0.5% bupivacaine + 10 ml normal saline).
Axillary block
Patients in group A will be placed in the supine position with the arm to be blocked abducted
and externally rotated. After sterilization of the axilla, the Ultrasound probe with a linear
high frequency (8-14 MHZ) transducer will be placed parallel to the anterior axillary fold at
the axilla to identify the axillary artery and to identify the hyperechoic median, ulnar, and
radial nerves in relation to the axillary artery. The musculocutaneous nerve which supplies
the skin of the lateral side of the forearm had to be blocked also. It is found between the
biceps brachii and coracobrachialis muscles. Lidocaine 1% was infiltrated subcutaneously 1 cm
lateral to the probe. The needle is inserted in-plane from the anterior aspect and directed
toward the posterior aspect of the axillary artery. All four nerves in the axillary region
will be blocked. A local anesthetic will be administered adjacent to each of the four nerves
(at least 5 ml for each).
Infraclavicular block
Patients in group B will be placed in the supine position with the head turned away from the
side to be blocked. The arm is abducted to 90 degrees and the elbow flexed. the skin is
disinfected and the transducer is positioned in the parasagittal plane to identify the
axillary artery. Surrounding the artery are the three cords of the brachial plexus: the
lateral, posterior, and medial cords. The needle is inserted in-plane short-axis technique
from the cephalad end of the probe, with the insertion point just inferior to the clavicle. A
local anesthetic will be injected posterior to the axillary artery to achieve a U-shaped
distribution around the artery (cephalad, caudad, and posterior).
Injection of 5 ml lidocaine 2% will be also used in all patients to eliminate tourniquet pain
and pain in the area of distribution of intercostobrachial nerve in case of use of a
tourniquet
Block assessment
After completion of all block procedures. A formal assessment of block efficacy will be
performed by an independent observer who will be masked to each subject's group allocation
every 10 min after needle removal for 30 min. surgery will be started once surgical
anesthesia will be achieved at any time point or until 30 min had elapsed. if surgical
anesthesia will not be achieved at 30 min the block will be considered failed and general
anesthesia will proceed.
Sensory blockade of the musculocutaneous, median, radial and ulnar nerves will be graded
according to the previously validated 3 point scale using a cold test: respectively: 0 = no
perception, 1 = decreased sensation, or 2 = normal sensation. A successful blockade is
defined as a complete sensory blockade (i.e., sensory block score = 0) within 30 minutes of
completing the block. If complete sensory blockade will not be achieved within 30 minutes,
the affected subject will be excluded from the study and categorized as a block failure. The
subject was offered a supplementary nerve block if there is sufficient time before surgery,
or general anesthesia will be proceeded to achieve surgical anesthesia.
The procedural time (seconds) for each block will be recorded. This duration is defined as
the interval from the ultrasound transducer's first contact with the subject to the time the
block needle exit the skin. Block onset time will be recorded (from a completed injection of
local anesthetic until loss of cold sensation) Duration of the block will be recorded,
defined as the time from completing injection of the local anesthetic till complete recovery
of sensory function, i.e., the cold test will be assessed every 30 min in the postoperative
period till patient feel the cold sensation
The motor blockade will be assessed by testing patients' handgrip strength using a hydraulic
handgrip dynamometer, baseline measurements will be recorded on both the ipsilateral and
contralateral sides. hand grip strength will be measured preoperative, 30 min from a block,
and after surgery. postoperative change in handgrip strength in the operative limb as a
percent reduction of preoperative baseline strength will be measured. The time needed to
regain full motor power will be measured.
All patients will be postoperatively monitored in the post-anesthesia care unit (PACU) for 1
h and thereafter discharged to their wards. Post-operative pain at the incision site will be
assessed by visual analog scale (VAS) and a score of more than 3 when recorded will be taken
as an endpoint for the duration of block and the patient was given supplementary analgesics
i.e. Inj. Diclofenac Sodium 1-1.5 mg/kg intramuscular. Subject satisfaction will be assessed
with a standardized question scored on a seven-point Likert scale: "Thinking about your nerve
blocks, how satisfied were you with them: where 1 is not at all, 4 is neutral, and 7 is
completely satisfied?"
Block related complications will be recorded such as failed block, motor weakness 24 h after
the block local anesthetic toxicity, vascular puncture, paraesthesia, and pneumothorax.