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We aimed to evaluate the analgesic effect of ultrasound guided Superficial cervical plexux block in tympanomastoid ear surgeries by comparing it with conventional general anaesthesia using systemic analgesic through observation of intra- and postoperative requirements of the total dose of systemic analgesics, visual analog scale (VAS) score, total duration of analgesia, vital parameters and the occurrence of any perioperative complications.
Patients meeting the inclusion criteria were randomly assigned into two groups, the control group and the study group, by a computer-generated randomization program. All patients in both group will be informed by the study methods,aim, side effect in clear language, written consent will be taken in clear spoken and written language, All patients of both groups ,once arrived to the OR, monitor will be attached, baseline SBP, DBP,MAP,SPO2,PULSE will be recorded, General anaesthesia (GA) will be induced with intravenous inj. of propofol 2-2.5 mg/kg, , fentanyl 1 microgram/kilogram (μg/kg). and atracuruim 0.5 mg/kg was given for muscle relaxation . In study Group patients, superficial CPB will be administered in a supine position with the head turned opposite to the side of the block using ultrasound guidance . Local anaesthetic will be injected alongside the posterior border of the muscle 2-3 cm in cranial and caudal directions. Using a 'fan' technique, the local anaesthetic will be administered subcutaneously and behind the sternocleidomastoid muscle. Ten millilitres of 0.25% bupivacaine were injected for each side of the block using a 1.5-inch 24-gauge needle. \[2\]. General anaesthesia will maintained with O2 + air (50:50), 3-litre flow, sevoflurane 2% to 2.5% and an intravenous inj. of atracuiruim 0.01 mg/kg every 20 min. An intraoperative rise in heart rate (\>100/min) and systolic blood pressure (≥ 20% from pre-induction value) will be recorded and managed by giving intravenous inj. of fentanyl 0.5 microgram/kg in incremental doses (dose of fentanyl did not exceed 3 μg/kg for less than three hours of surgery). At the end of the surgery, the reversal of residual neuromuscular block will be done and the patient will be extubated. The patient will be then transferred to the recovery room and the severity of pain will be assessed by a VAS scale ( visual analog score scale ), which is a straight line denoting one end with no pain and the other end with the worst pain. VAS score was calculated as follows: 0, no pain; 1-3, mild pain; 4-6, moderate pain; 7-9, severe pain; 10, worst pain. The VAS score will be assessed when the patient could follow verbal commands. Evaluation of block for adequate analgesia intraoperatively will be done in terms of the total requirement of intravenous analgesics through the observation of heart rate and blood pressure and postoperatively, it will be done by observing VAS score, time of first demand for a bolus of rescue analgesic (intravenous paracetamol) and total requirement of rescue analgesic in 24 hours.. Pulse, mean blood pressure (BP), oxygen saturation (SpO2) and any side effects were also noted.
Age
20 - 40 years
Sex
ALL
Healthy Volunteers
No
Ain Shams University
Cairo, Egypt
Start Date
April 1, 2025
Primary Completion Date
November 20, 2025
Completion Date
December 1, 2025
Last Updated
November 21, 2025
46
ESTIMATED participants
nerve block with bupivacaine 0.25%
PROCEDURE
Lead Sponsor
Ain Shams University
NCT07099222
NCT07368413
Data Source & Attribution
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