Ultrasound-Guided Transversalis Fascia Plane Block Versus Caudal Block for Postoperative Analgesia in Children Undergoing Inguinal Herniorrhaphy

Not Applicable

Recruiting

• Conditions: Ultrasound; Transversalis Fascia Plane Block; Caudal Block; Postoperative Analgesia; Children; Inguinal Herniorrhaphy

• Registration Number: NCT06725667
• Lead Sponsor: Tanta University

Brief Summary

The aim of this study is to compare ultrasound-guided transversalis fascia plane block and caudal block for postoperative analgesia in children undergoing inguinal herniorrhaphy.

Detailed Description

Surgical repair of inguinal hernia is one of the most common day-case surgeries in the pediatric population. It is associated with significant postoperative pain and discomfort.

Caudal block analgesia is a popular and reliable technique for lower abdominal surgeries and found to be safe and effective for providing intra and postoperative analgesia in pediatric patients.

transversal fascia plane block (TFPB) aims to provide analgesia for invasive procedures of the inguinal and sublingual areas by blocking the subcostal (T12), ilioinguinal (L1) and iliohypogastric (T12-L1) nerves. Several studies have reported TFPB as the analgesic method of choice for procedures involving the T12-L1 dermatome region, including iliac bone graft harvesting, cesarean section, and inguinal hernia repair

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-05
• Study First Posted: 2024-12-10
• Study Start: 2024-12-11
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-12
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age from 1 to 7 years.
• Both sexes.
• American Society of Anesthesiology (ASA) physical status I-II.
• Scheduled for inguinal herniorrhaphy under general anesthesia (GA).

Exclusion Criteria

• Repeated surgeries.
• Known allergic reactions to any of the study's drugs.
• Infection at the site of block needle entry.
• Bleeding diathesis.
• Neurological disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to the 1st rescue analgesia	24 hours postoperatively	Time to the first request for the rescue analgesia (time from the end of surgery to first dose of paracetamol administrated).

Secondary Outcome Measures

Name	Time	Method
Total paracetamol consumption	24 hours postoperatively	Each of the five items of the Face, legs, activity, cry, and consolability (FLACC) scale will be scared, ranging from 0 to 2, which will be then aggregated to obtain a total score ranging from 0 to 10. Higher scores on the scale indicated a higher level of pain intensity. If the FLACC scale exceeds three, IV paracetamol (15 mg/kg) will be given.
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	Degree of pain will be assessed using the Face, legs, activity, cry, and consolability (FLACC) scale. Each of the five items of the FLACC scale will be scared, ranging from 0 to 2, which will be then aggregated to obtain a total score ranging from 0 to 10. Higher scores on the scale indicated a higher level of pain intensity.
Hear rate	Every 15 min till the end of surgery (Up to 2 hours)	Hear rate will be recorded preoperatively, before performing of block, and every 15 min till the end of surgery.
Mean arterial pressure	Every 15 min till the end of surgery (Up to 2 hours)	Mean arterial pressure will be recorded preoperatively, before performing of block, and every 15 min till the end of surgery.
Degree of patient's parents satisfaction	24 hours postoperatively	Degree of patient's parents satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
Incidence of adverse events	24 hours postoperatively	Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication related to block such as hematoma, neurological injury, deep visceral injury, or local anesthetic toxicity will be recorded.

Trial Locations

Locations (1)

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