Transversus Abdominis Plane Block Versus External Oblique Intercostal Plane Block for Postoperative Analgesia in Pediatrics Undergoing Open Nephrectomy

Not Applicable

Recruiting

• Conditions: Transversus Abdominis Plane Block; Postoperative Analgesia; External Oblique Intercostal Plane Block; Pediatrics; Open Nephrectomy
• Interventions: Other: Transversus Abdominis Plane Block; Other: External Oblique Intercostal Plane Block

• Registration Number: NCT06452225
• Lead Sponsor: Tanta University

Brief Summary

The aim of this study is to compare the ultrasound guided TAP Block and EOIP block for postoperative analgesia in pediatrics undergoing open nephrectomy.

Detailed Description

Nephrectomy in children may also be for malignant conditions of the kidney and adrenal glands. The major indications for nephrectomy vary in different parts of the world and in different age groups and sexes with some recording more benign conditions and others more of malignancies Ultrasound-guided transversus abdominis plane (TAP) block is a relatively new technique to infiltrate regional anesthesia in which local routine anesthetics are injected between the internal oblique and transverse abdominal muscles. The purpose is to provide analgesia to the parietal peritoneum as well as the skin and muscles of the anterior abdominal wall.

External oblique intercostal plane block (EOIPB) has been reported by Elsharkawy et al. in 2021 as a significant modification of fascial plane blocks in that it may engage the upper lateral abdominal walls consistently. In comparison to quadratus lumborum block (QLB) and erector spinae plane block (ESPB) , The advantage of EOIPB is that it may be performed with the patient supine. Furthermore, in comparison to serratus intercostal plane block (SIPB), it generates more extensive analgesic effects throughout the whole midline of the abdomen .

Study Timeline

• Study First Submitted: 2024-05-30
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-04
• Study First Posted: 2024-06-11
• Study Start: 2024-06-12
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age ≤ 18 years.
• Both sexes.
• American Society of Anesthesiology (ASA) physical status I-III.
• Scheduled for open nephrectomy.

Exclusion Criteria

• Abnormal blood coagulation.
• Scar, infection, and tumor of puncture site.
• History or family history of high malignant fever.
• Severe cardiovascular problems.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transversus Abdominis Plane Block	Transversus Abdominis Plane Block	Patients will receive ultrasound guided transversus abdominis plane block.
External Oblique Intercostal Plane Block	External Oblique Intercostal Plane Block	Patients will receive external oblique intercostal plane block.

Primary Outcome Measures

Name	Time	Method
Time to the 1st rescue analgesia	24 hours postoperatively	A standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 15 mg /kg/8 hrs as routine analgesia. Rescue analgesia of morphine will be given as 0.05 mg/kg if face, legs, activity, and cry consolability scale (FLACC) ≥ 4 and the maximum allowed dose is 0.1mg/kg every 4 hours. FLACC will be assessed at 0, 2, 4, 8, 12 and 24h postoperatively.; it will be measured from the end of surgery to first dose of morphine administrated.

Secondary Outcome Measures

Name	Time	Method
Intraoperative fentanyl consumption	Intraoperatively	Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).
Degree of pain	24 hours postoperatively	The pain will be assessed by using the face, legs, activity, and cry consolability scale (FLACC). The level of response for each observation is given a numerical value rating from "0" to "2," with "0" being the most comfortable with no pain and "2" being the most painful , which results in a total score between "0" and "10".; It will be assessed at 0, 2, 4, 8, 12 and 24h postoperatively.
Total morphine consumption	24 hours postoperatively	Rescue analgesia of morphine will be given as 0.05 mg/kg if the face, legs, activity, and cry consolability scale (FLACC) ≥ 4 and the maximum allowed dose is 0.1mg/kg every 4 hours.
Mean arterial pressure	Every 15 minutes till the end of surgery	Mean arterial pressure will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt