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

NCT ID: NCT06267820

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2023-12-10

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

Conditions

Postoperative Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: QUADRUPLE

Study Groups

TAP block with bupivacaine and ketorolac

Ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg).

Group Type: ACTIVE_COMPARATOR

Bupivacain

Intervention Type: DRUG

analgesia

Ketorolac

Intervention Type: DRUG

analgesia

TAP block with bupivacaine

ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg).

Group Type: ACTIVE_COMPARATOR

Bupivacain

Intervention Type: DRUG

analgesia

Interventions

Bupivacain

analgesia

Intervention Type: DRUG

Ketorolac

analgesia

Intervention Type: DRUG

Other Intervention Names

bupivacaine

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Fouad Soliman

Lecturer of Anesthesia and ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fouad I Soliman, MD

Role: PRINCIPAL_INVESTIGATOR

Sohag University

Locations

Fouad Ibrahim Soliman

Sohag, , Egypt

Countries

Egypt

Other Identifiers

2010

Identifier Type: -

Identifier Source: org_study_id