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

NCT06752252 | Recruiting

• 1 other identifier: 866
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 2

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.

Conditions

Analgesia, Postoperative

Keywords

postoperative analgesia; ultrasound guided paravertebral block; ultrasound guided erector spinae plane block; inguinal hernia repair in pediatric

Outcome Measures

Primary Outcomes (1)

• The total amount of rescue analgesia (Ibuprofen consumption)

  The total consumption of rescue analgesia (Ibuprofen consumption) postoperative

  for 24 hours postoperative

Secondary Outcomes (5)

• 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

• The time to first request of rescue analgesia (Ibuprofen)

  for 24 hours postoperative

• The total number of patients requiring additional dose of intraoperative fentanyl.

  during operation period

• To record the incidence of complications

  24 hours postoperative

• Over all parent's satisfaction

  24 hours postoperative

Study Arms (3)

Group paravertebral (PVB) block

ACTIVE COMPARATOR

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

Group erector spinae plane (ESP) block

ACTIVE COMPARATOR

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

Control group (group C)

ACTIVE COMPARATOR

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

Interventions

ultrasound guided paravertebral block PROCEDURE

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

Group paravertebral (PVB) block

Ultrasound guided erector spinae plane block PROCEDURE

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

Group erector spinae plane (ESP) block

control group C PROCEDURE

will receive standard general anesthesia with pain management protocol without regional block.

Control group (group C)

Eligibility Criteria

• Age: 24 Months - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parents acceptance
• \. Age: preschool and school age child (24 months-12 years old).
• \. Sex: both sex (males or females).
• \. Physical status: ASA 1\& II.
• \. Type of operation: elective unilateral inguinal hernia repair

You may not qualify if:

• Patient with any contraindications of regional blocks (as coagulopathy or local infection at injection site)
• \. Patients with known history of allergy to the study drugs (bupivacaine and lidocaine).
• \. Advanced hepatic, renal, cardiovascular, neurologic and respiratory diseases.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (2)

faculty of human medicine, Zagazig university hospitals

El Sharkia, Egypt

RECRUITING

Faculty of Human Medicine, Zagazig University

El Sharkia, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dina Sadek Salem, MD

CONTACT

0109933513; dinamaghraby@yahoo.com

Fatima Ahmed, MD

CONTACT

01018951337

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: anesthetist not sharing in the study will assess patients
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: Postoperative analgesia after inguinal hernia repair in pediatric by ultrasound guided paravertebral block or erector spinae block

Study Record Dates

• First Submitted: December 21, 2024
• First Posted: December 30, 2024
• Study Start: December 30, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)