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

Ultrasound Guided Paravertebral Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Inguinal Hernia Repair in Pediatric Patients: a Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Analgesia, Postoperative
• Intervention / Treatment: Procedure: ultrasound guided paravertebral block; Procedure: Ultrasound guided erector spinae plane block; Procedure: control group C

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 Type: Interventional
• Enrollment (Estimated): 158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dina Sadek Salem, MD; Phone Number: 002 0109933513; Email: dinamaghraby@yahoo.com
• Study Contact Backup: Name: Fatima Ahmed, MD; Phone Number: 002 01018951337

Study Locations

• Egypt
  • El sharkia, Egypt
    • Recruiting
    • faculty of human medicine, Zagazig university hospitals
    • Contact: Ahmed Hegab, MD; Phone Number: 002 01000089347
  • El sharkia, Egypt
    • Recruiting
    • Faculty of Human Medicine, Zagazig University
    • Contact: Ahmed Hegab, MD; Phone Number: 002 01000089347; Email: dinamaghraby@yahoo.com
    • Contact: FATIMAH MAHMOUD, MD; Phone Number: 002 01018951337
    • Contact: DINA SALEM, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group paravertebral (PVB) block; In the lateral decubitus and after sterilization and identifying the level of T10 ,linear ultrasound probe will be placed in the midline over the spinous process at the chosen level, then the probe will be moved laterally to view the lamina and hyperechoic transverse process ,the pleural should be visible as a bright white line .The needle should be inserted in -plane from lateral to medial and the needle tip should end in a hypoechoic triangular space .Correct needle placement should be confirmed by anterior displacement of pleura with injection of small volume of saline then 0.5 ml/kg of a mixture of 0.25 ℅ bupivacaine and 1℅ lidocaine (1:1) will be injected	Procedure: ultrasound guided paravertebral block; after sterilization and identifying the level of T10 ,linear ultrasound probe will be placed in the midline over the spinous process at the chosen level, then the probe will be moved laterally to view the lamina and hyperechoic transverse process ,the pleural should be visible as a bright white line .The needle should be inserted in -plane from lateral to medial and the needle tip should end in a hypoechoic triangular space. Correct needle placement should be confirmed by anterior displacement of pleura with injection of small volume of saline then 0.5 ml/kg of a mixture of 0.25 ℅ bupivacaine and 1℅ lidocaine (1:1) will be injected
Active Comparator: Group erector spinae plane (ESP) block; In the lateral decubitus position ,after sterilization, the linear ultrasound probe will be placed over transverse process of T10 ,after optimizing the image in sagittal or transverse scanning ,A 50 mm 22-G needle will be placed under the erector spinae muscle in -in plane orientation until it contacted T8 transverse process in the cranial caudal direction ,after hydro dissection and confirmation that the tip of the needle is between the transverse process and the fascia of the erector spinae muscle group, 0.5 ml/kg of a mixture of 0.25 ℅bupivacaine and 1℅ lidocaine (1:1) will be injected and the surgery will be started after 15 min	Procedure: Ultrasound guided erector spinae plane block; After sterilization, the linear ultrasound probe will be placed over transverse process of T10 ,after optimizing the image in sagittal or transverse scanning ,A 50 mm 22-G needle will be placed under the erector spinae muscle in -in plane orientation until it contacted T8 transverse process in the cranial caudal direction ,after hydro dissection and confirmation that the tip of the needle is between the transverse process and the fascia of the erector spinae muscle group, 0.5 ml/kg of a mixture of 0.25 ℅bupivacaine and 1℅ lidocaine (1:1) will be injected
Active Comparator: Control group (group C); will receive standard general anesthesia with pain management protocol without regional block. Pain management protocol for all patients will include IV paracetamol 15 mg/kg every 6 hrs. (max dose for children <50 kg is 60 mg/kg daily and if body weight ≥ 50 kg max dose is 4 gm daily) . Ibuprofen will be given as rescue analgesia 10 mg/kg IV if MOPS was > 3 at rest or after movement and can be repeated every 6 hrs not exceeding 400 mg/dose and max daily dose 40 mg/kg.	Procedure: control group C; will receive standard general anesthesia with pain management protocol without regional block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total amount of rescue analgesia (Ibuprofen consumption)	The total consumption of rescue analgesia (Ibuprofen consumption) postoperative	for 24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity at rest (static) and after movement or coughing (dynamic)	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)	0 minutes immediate postoperative ( on arrival to PACU), 30 minutes, 1hs, 2hs, 4hs, 8hs, 12 hrs and 24hs postoperatively
The time to first request of rescue analgesia (Ibuprofen)	the time from giving block till time of first request of ibuprofen when MOPS > 3 at rest or after movement	for 24 hours postoperative
The total number of patients requiring additional dose of intraoperative fentanyl.	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)	during operation period
To record the incidence of complications	To record the incidence of complications (hematoma, local anesthetic toxicity, pneumothorax, infection, hypotension, epidural or intrathecal spread)	24 hours postoperative
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)	24 hours postoperative

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: December 21, 2024
• First Submitted That Met QC Criteria: December 23, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 31, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: postoperative analgesia; ultrasound guided paravertebral block; ultrasound guided erector spinae plane block; inguinal hernia repair in pediatric
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: 866

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No