Ultrasound Guided Paravertebral Block Versus Erector Spinae Block for Postoperative Analgesia After Inguinal Hernia Repair in Pediatric Patients

Not Applicable

Recruiting

• Conditions: Analgesia, Postoperative

• Registration Number: NCT06752252
• Lead Sponsor: Zagazig University

Brief Summary

The aim of the study is to compare postoperative analgesia in pediatric patients undergoing inguinal hernia repair by comparing the efficacy of ultrasound guided paravertebral block versus ultrasound guided erector spinae plane block.

Detailed Description

* To assess the total amount of rescue analgesic consumption in the first 24 hours post-operatively in each group.

* To measure the time of first request of rescue analgesia and to assess pain intensity at rest (static) and after movement or coughing (dynamic) using 10 points Modified Objective Pain Score (MOPS).

* To record the incidence of complications (hematoma, local anesthetic toxicity, pneumothorax, infection, hypotension, epidural or intrathecal spread).

* Over all parent's satisfaction: The parents will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia).

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-21
• Study First Submitted QC: 2024-12-23
• Study Start: 2024-12-30
• Study First Posted: 2024-12-30
• Last Update Submitted: 2024-12-31
• Last Update Posted: 2025-01-01
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

1 - Parents acceptance

2. Age: preschool and school age child (24 months-12 years old).

3. Sex: both sex (males or females).

4. Physical status: ASA 1& II.

5. Type of operation: elective unilateral inguinal hernia repair

Exclusion Criteria

1- Patient with any contraindications of regional blocks (as coagulopathy or local infection at injection site)

2. Patients with known history of allergy to the study drugs (bupivacaine and lidocaine).

3. Advanced hepatic, renal, cardiovascular, neurologic and respiratory diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The total amount of rescue analgesia (Ibuprofen consumption)	for 24 hours postoperative	The total consumption of rescue analgesia (Ibuprofen consumption) postoperative

Secondary Outcome Measures

Name	Time	Method
Pain intensity at rest (static) and after movement or coughing (dynamic)	0 minutes immediate postoperative ( on arrival to PACU), 30 minutes, 1hs, 2hs, 4hs, 8hs, 12 hrs and 24hs postoperatively	by using 10 points Modified Objective Pain Score (MOPS)(0=no pain, 1-3=mild pain, 4-6=moderate pain, and 7-10= sever pain)
The time to first request of rescue analgesia (Ibuprofen)	for 24 hours postoperative	the time from giving block till time of first request of ibuprofen when MOPS \> 3 at rest or after movement
The total number of patients requiring additional dose of intraoperative fentanyl.	during operation period	Number of patients receive additional dose of intra operative fentanyl ( increase in the mean blood pressure or heart rate 20% above base line readings, fentanyl in a dose 0.5 mcg/kg will be given to the patient)
To record the incidence of complications	24 hours postoperative	To record the incidence of complications (hematoma, local anesthetic toxicity, pneumothorax, infection, hypotension, epidural or intrathecal spread)
Over all parent's satisfaction	24 hours postoperative	The parents will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia)

Trial Locations

Locations (2)

faculty of human medicine, Zagazig university hospitals; 🇪🇬 El sharkia, Egypt

Faculty of Human Medicine, Zagazig University; 🇪🇬 El sharkia, Egypt