Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05791058 |
| Other study ID # |
Ain Shams university 17 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 20, 2023 |
| Est. completion date |
May 20, 2024 |
Study information
| Verified date |
March 2023 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Recently, the Combined suprascapular nerve block and axillary nerve block (SSNB+ANB) was
proposed to provide anesthesia and postoperative analgesia for shoulder surgery as a safe
alternative to interscalene block. These two peripheral nerves are responsible for the
majority of the sensory innervation of the shoulder.
PENG block has been studied extensively in hip surgeries, but its place in shoulder surgeries
is not yet clear. It is a new technology reported for block of articular branches of the
shoulder and well pericapsular spread around the glenohumeral joint Therefore, achieving pain
relief while avoiding motor block allows us not only to provide an early rehabilitation
program in the postoperative period, but also to control the chronic nociceptive activation
secondary to pain-induced movement
Description:
Preoperative:
Routine preoperative assessment will be done before operation to all patients including
history, clinical examination and laboratory investigations (complete blood picture, kidney
function tests, liver function tests, pro-thrombin time, and partial thromboplastin time).
Chest X-ray, electrocardiogram [ECG] will be done for patients above 40 years old.
All patients will be informed about the study design and objectives as well as tools and
techniques. Informed consent will be signed by every patient prior to inclusion in the study.
All patients will be informed about the analgesic regimen and will be instructed on how to
express pain intensity with use of the visual analogue scale (VAS) (10cm unmarked line in
which 0=no pain, 10cm=the worst imaginable pain)
Anesthetic techniques:
1. General Anesthesia Technique:
Pre-medications will be given to every patient of the two including groups in the form
of midazolam (0.05 mg/kg, IV) together with omeprazole (40 mg, IV) and ondansetron (4
mg, IV) on arrival to the operative room after establishing a peripheral intravenous
access. Vital signs will be continuously monitored. After pre-oxygenation for 3 minutes,
general anesthesia is induced to all patients with fentanyl (1-2 μg/kg, IV), propofol
(1-2mg/Kg, IV), and atracurium (0.5mg/Kg, IV) to facilitate endotracheal intubation.
Intermittent positive pressure ventilation of both lungs will be applied (to maintain O2
saturation >98% and end tidal carbon dioxide measurement around 35-38 mmHg). Maintenance
of anesthesia will be achieved using intermittent positive pressure ventilation with
inhalation of 1-1.5% isoflurane in 50% O2 and atracurium (0.1mg/Kg, IV) every 30 minutes
to maintain muscle relaxation.
2. Ultrasound guided PENG shoulder block Technique (Group A):
The patient's arm is placed in external rotation and abducted at 45 degrees. A linear
ultrasound probe will be placed longitudinally between the coracoid and the humeral
head. After defining the humeral head, the tendon of the subscapular muscle and the
deltoid muscle over it, a 50-mm needle will be inserted using the ''in plane''
technique. When the needle pass through the deltoid muscle and touched the subscapularis
tendon, a bone-like hard tissue will be felt and the needle could not be advanced
further. The needle tip will be placed between the deltoid muscle and subscapularis
tendon, and 20 cc of 0.25% bupivacaine hydrochloride with 4mg dexamesathone will be
injected.
3. Ultrasound guided combined suprascapular nerve block and axillary nerve block (SSNB+ANB)
Technique (Group B):
The ultrasound guided suprascapular nerve block:
The patient will be positioned in a semi-recumbent position with the operating arm on the
contralateral shoulder. The probe will be kept over the scapular spine to identify the
trapezius and the supraspinatus muscle. Then, it will be moved laterally to identify the
concavity of the supraspinatus fossa and the hyper-echoic fascia of the supraspinatus muscle.
In the concavity of the fossa, the suprascapular artery and the suprascapular nerve run in
close proximity. 10 ml of 0.25% bupivacaine with 2mg dexamethasone will be injected below the
supraspinatus fascia.
The ultrasound guided axillary nerve block:
The patients is positioned in a semi-recumbent position with the arm slightly flexed and
adducted at the elbow. The posterior surface of the humerus will be visualised in the short
axis view. So, the AN and posterior circumflex artery will be visualised longitudinally. 10
ml of 0.25% bupivacaine with 2mg dexamethasone will be injected into space.
The blocks will be considered a failed block if the block is not successful 30 min after the
injection of the local anaesthetic.
Group A 20 Patients of this group will receive ultrasound guided pericapsular nerve group
shoulder block (PENG Block) at the end of surgery using 20 ml of 0.25% bupivacaine with 4mg
dexamethasone with a maximum dose of (3mg/kg).
Group B 20 Patients of this group will receive single shot suprascapular and axillary nerve
using a single dose of 10ml of 0.25% bupivacaine with 2mg dexamethasone each at the end of
surgery for postoperative pain relief.
Group C 20 patients of this group will receive general anesthesia without nerve block. In the
post anesthesia care unit (PACU) for first hour and in ward afterwards , all patients will be
assessed for presence and severity of pain at at 1, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours
postoperatively or at any time patient suffers from pain with visual analog score and
recording its value at any patient visit.
Nalbuphine 0.1 mg/kg is the rescue analgesic that will be given to any patient who will
suffer pain with VAS more than 3.
