Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05512728 |
| Other study ID # |
MS-389-2020 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 20, 2020 |
| Est. completion date |
December 20, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Invistigators hypothesized that using of VR distraction technique during performing
peripheral regional anesthesia (supraclavicular block) would lead to better perioperative
analgesia and less anxiety.
Description:
Methodology I. Study design This is a controlled randomized prospective study. II. Study
setting and location The study will be conducted at Cairo University Hospital - orthopedic
surgery unit.
III. Study population Participants will be adult patients (above 18 years), ASA I-II,
scheduled for elective forearm orthopedic surgeries under ultrasound guided supraclavicular
approach for brachial plexus block.
IV. Study Procedures
1. Randomization Patients will be randomly allocated by a computer-generated table into one
of the study groups; the randomization sequence will be concealed in sealed envelopes.
Patients and data collector will be blind to group assignment.
2. Study Protocol Following approval from Ethics and Research Committee of Anesthesia
Department, Faculty of Medicine, Cairo University, All patients will be subjected to
systematic preoperative assessment including history taking, physical examination, and
review of the results of routine investigations.
Upon arrival to the preparation room: A 20 gauge IV cannula is inserted into a peripheral
vein then patients will be transferred to the operating room where basic monitoring
Electrocardiography (ECG), Non-invasive Blood Pressure (NIBP) and pulse oximetry are
attached. Baseline heart rate, blood pressure, oxygen saturation and respiratory rate will be
recorded.
All patients will receive ultrasound guided supraclavicular block. The skin is disinfected
and the transducer is positioned in the transverse plane immediately proximal to the
clavicle, the transducer is tilted caudally, as if to image the chest contents, to obtain a
cross-sectional view of the subclavian artery the brachial plexus is seen as a collection of
hypo echoic oval structures posterior and superficial to the artery... Using a 25- to
27-gauge needle, 1-2 mL of local anesthetic is injected into the skin 1 cm lateral to the
transducer .The distribution of local anesthetic via small-volume injections is observed as
the needle advances through tissue layers (hydro-localization); small-volume injections are
used to avoid inadvertent needle insertion into the brachial plexus. The block needle is then
inserted in plane toward the brachial plexus, in a lateral-to-medial direction... Insertion
of the needle into the sheath is often associated with a palpable "pop." After careful
aspiration, 1-2 mL of local anesthetic is injected to confirm proper needle placement. When
the injection displaces the brachial plexus away from the needle, an additional advancement
of the needle 1-2 mm closer to the plexus may be required to accomplish adequate local
anesthetic spread. When the injection of local anesthetic does not appear to result in a
spread around the brachial plexus, needle repositioning may be necessary. Typically, 20-25 mL
of local anesthetic is required for adequate block.
After local anesthetic injection through the block needle, measurements of brachial plexus
blockade will be performed every 5 minutes until 30 minutes. Sensory blockade of the
musculocutaneous, median, radial, and ulnar nerves was graded according to a 3-point scale
using a cold test: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 =
anesthesia (patient cannot feel touch). Sensory blockade of the musculocutaneous, median,
radial, and ulnar nerves will be assessed on the lateral aspect of the forearm, the volar
aspect of the thumb, the lateral aspect of the dorsum of the hand, and the volar aspect of
the fifth finger, respectively. Motor blockade will be also graded on a 3-point scale: 0 = no
block, 1 = paresis, 2 = paralysis. Motor blockade of the musculocutaneous, radial, median,
and ulnar nerves was evaluated by elbow flexion, thumb abduction, thumb opposition, and thumb
adduction, respectively. Overall, the maximal composite score was 16 points. We will consider
the patient ready for surgery when a minimal composite score of 14 points is achieved,
provided the sensory block score is equal or superior to 7 of 8 points. (12) If, after 30
minutes, the composite score was <14 points, the patient will be excluded from the study and
further management will be according to discretion of the attending anesthetist.
Patients in control group will not receive any additional management Patient in the VR group,
before wearing the device, they will have the procedure explained to them, and reassured that
they can terminate the VR session any time during the procedure. The VR set will be applied
before performing the supraclavicular block and will be removed at the end of the procedure
before leaving the operating room.
IVR simulation used:
The IVR environment was provided by Shinecon VR (Shinecon, china). Shinecon VR features, have
a large field of view and high-quality display; with aspheric lens , lens diameter 40MM, view
angle 108 , sharpness 99%, visibility 100%, color .38MM and pupillary distance adjustment 65
MM.
The shinecon VR setup was powered by a HUAWEI Y7 prime phone running the freely available IVR
software.
Shinecon VR provides videos for nature, forest, wind, desert and animals. That included
noise-cancelling headphones playing background sound from the IVR simulation.
•
Intraoperative sedation:
- (titration of 0.05 mg/kg per dose) according to Modified Wilson sedation scale Score to
achieve grade 1 (Oriented, eyes may be closed but can respond to 'Can you tell me your
name?' 'Can you tell me where you are right now?'
- titration of analgesia (fentanyl 1 mcg/kg per dose) according to numeric pain score to
reach Zero pain.
- titration will be administered to all patients according to the attending anesthetist
dissertation
Ultrasound-guided supraclavicular brachial plexus block simulating a single injection between
the subclavian artery (SA) and the first rib Measured Parameter Demographic data of the
patient
- Hemodynamics (heart rate, systolic and diastolic arterial blood pressure) will be
recorded at baseline (upon patient admission to OR), 1 min after block then every 5
minutes till skin incision, 1 minute after skin incision and every 5 minutes till skin
closure
- Total dos of midazolam needed for patient to relieve anxiety.
- The total dose of fentanyl
- The VR group, time required to set-up the virtual reality device, session lengths, early
discontinuation, adverse events, such as: headache, nausea, or vomiting; and proportion
of patients wishing to use the technology again
- The sedation level will be monitored using Modified Wilson sedation scale Score
Description
1. Oriented, eyes may be closed but can respond to 'Can you tell me your name?' 'Can
you tell me where you are right now?'
2. Drowsy; eyes may be closed, arousable only to command: '(name), please open your
eyes'.
3. Arousable to mild physical stimulation (earlobe tug)
4. Unarousable to mild physical stimulation
- The pain level will be monitored using numeric pain scale
