CTRI

â€¢The aim of this study is to compare dexmedetomidine and butorphanol as an adjuvant along with bupivacaine in ultrasound-guided erector spinae plane block for perioperative analgesia in children undergoing thoracoabdominal surgeries.

â€¢PRIMARY OUTCOME -

1.Pain score at predefined time points following surgery for upto 24 hours.

â€¢

â€¢SECONDARY OUTCOME â€“

1.Timing of rescue analgesia.

2.Haemodynamic stability

AIMS AND OBJECTIVES

Following approval by the Departmental Protocol Committee, Department of Paediatric Anaesthesia, and the Institutional Ethics Committee, Postgraduate Institute of Child Health (PGICH), Noida, the present study would be conducted in the institution on paediatric patients undergoing open thoracic and abdominal surgeries. It is a randomized controlled study. Informed written consent will be taken from the parents/guardians.

Inclusion Criteria:

1. Age: 1 year - 18 years

2. ASA I and II patients of either sex

3. Elective thoracic and abdominal surgery (such as â€“ decortication, chest wall abscess drainage, herniotomy, exploratory laparotomy etc.)

Exclusion Criteria

1. Evidence of coagulopathy or thrombocytopenia

2. History of bleeding or clotting disorders

3. Local infection

4. Allergy to drugs used in study

5. Intellectual disability

6. Chronic pain disorder

7. On chemotherapy

METHODOLOGY

All children would be kept nil per oral before surgery as per standard ASA guidelines. The intravenous cannula would be secured in the ward before the patient is shifted to the operating room on the

morning of surgery. Premedicate the child with intravenous midazolam 0.1 mg/kg, glycopyrrolate 4mcg/kg, ketamine 0.5 mg/kg. Transfer to the operating room, electrocardiography, non-invasive

blood pressure, and pulse oximetry would be connected. The baseline preoperative parameters recorded. All patients will be randomized to one of two groups using computer generated random

numbers and a 1:1 allocation ratio. The primary investigator performing the block and the investigator analysing the data will be blinded to the group allocation. After induction, patient will be placed in

lateral position to apply ESPB. An assistant, who will be neither involved in the study nor will be participating in the perioperative period or the postoperative follow-up, will prepare study drugs.

Group A will receive injection 0.25% bupivacaine, single shot, 0.5ml/kg with 1 mcg/kg dexmedetomidine and Group B will receive injection 0.25% bupivacaine, single shot, 0.5ml/kg with 25

mcg/kg butorphanol deep to the erector spinae muscle adjacent to transverse processes. After the block, the patient of either group will be monitored for oxygen saturation, tachycardia, hypertension

and end tidal carbon dioxide every 15 minutes. If pain persists rescue analgesia in the form of Injection paracetamol 15mg/kg will be administered. The time duration and the time of the block given till

the first dose of rescue analgesia will be noted. On arrival in the post anaesthesia care unit (PACU), oxygen saturation (SpO2), Heart rate (HR), Mean blood pressure (MBP), end tidal carbon dioxide

(EtCO2) and age appropriate scoring will be done. FLACC scoring (<=10 years) and VAS score (>10 years) immediately after the postoperative period once the patient is awake, then at 15 minutes, at

30 minutes, 60 minutes, 90 minutes and 120 minutes, 4 hourly up to 24 hours. Duration of analgesia, requirement of rescue analgesia usage and side effects if any will be noted.