Combined Ketorolac Bupivacaine Versus Bupivacaine Alone for TAP Block in Children Undergoing Lower Abdominal Surgeries

Phase 2

Completed

• Conditions: Postoperative Pain, Acute
• Interventions: Drug: Bupivacain; Drug: Ketorolac

• Registration Number: NCT06267820
• Lead Sponsor: Sohag University

Brief Summary

Control of of pain in children is fundamental. TAP block is associated with less side effects compared with other neuraxial techniques especially when done under ultrasound guidance.

Ketorolac has analgesic effect comparable to morphine. Children were arranged randomly into two equal groups, forty-five children in each.

Group (K) (n= 45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg).

Group (T) (n =45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg)

Detailed Description

This prospective randomized controlled study were carried out in Sohag university hospitals after getting approval from medical research ethics committee and written informed consents from the patients' parents or legal guardians. This study included 90 ASA status I and II children aged 6-12 years undergoing elective lower abdominal surgeries.Preoperative assessment:

* History taking from the parents.

* Complete physical examination.

* Laboratory investigations: Complete Blood Picture and coagulation profile. Preoperative preparation

Before starting, standard monitoring will be as follow:

1. Non-invasive blood pressure (systolic and diastolic).

2. Peripheral Oxygen saturation (SpO2%). After insertion of intravenous line, all children will receive atropine premedication (0.01-0.02 mg/kg). General anesthesia will be induced using propofol 1% (2 mg/kg), atracurium (0.5 mg/kg) to facilitate endotracheal intubation. Anesthesia will be maintained using isoflurane (1-2%) with controlled ventilation.At the end of operation, muscle relaxant is reversed using neostigmine and atropine.

Intraoperative hemodynamic parameters will be recorded throughout the surgery at fixed intervals (at time of skin incision then after every 5 min till the end of surgery).

Then TAP block were done under ultrasound guidance using either bupivacaine and ketorolac or bupivacaine alone

Study Timeline

• Study Start: 2023-06-01
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-10
• Study First Submitted: 2023-12-13
• Study First Submitted QC: 2024-02-15
• Study First Posted: 2024-02-20
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-22
• Last Update Posted: 2024-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• ASA status I and II children Age 6-12 years Elective lower abdominal surgeries.

Exclusion Criteria

• Parents' or legal guardians' refusal.
• A history of developmental delay or mental retardation.
• ASA III and IV.
• A known allergy to ketorolac or bupivacaine.
• Hemodynamic unstable patient
• Urgent surgeries

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP block with bupivacaine and ketorolac	Bupivacain	Ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg).
TAP block with bupivacaine	Bupivacain	ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg).
TAP block with bupivacaine and ketorolac	Ketorolac	Ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg).

Primary Outcome Measures

Name	Time	Method
1st analgesic requirement	24 hours	the time at which the 1st need for analgesia is given.
Number of patients who requested analgesia	24 hours	Number (percentage)of patients who requested analgesia

Secondary Outcome Measures

Name	Time	Method
heart rate	24 hours	the patient vital sign (beats/min)
Total rescue analgesia	24 hours	Total rescue analgesia in the first 24 h. postoperatively
Satisfaction of the parents regarding their children analgesia	24 hours	using 5- point satisfaction scale (1= Very satisfied, 2=Satisfied,3= Neither satisfied nor dissatisfied,4= Dissatisfied, 5= Very dissatisfied).; This satisfaction will be done by parents according to the VAS, incidence of side effects and analgesic requirements
Number of children in each group who required analgesia in the first 24 h postoperatively	24 hours	Number of children in each group who required analgesia in the first 24h postoperatively
blood pressure	24 hours	The patients blood pressure (mmHg)

Trial Locations

Locations (1)

Fouad Ibrahim Soliman; 🇪🇬 Sohag, Egypt