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Recruiting NCT06752252

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

No phase Interventional Analgesia, Postoperative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ultrasound guided paravertebral block, Ultrasound guided erector spinae plane block, control group C.
Who it may be relevant to
Registry conditions: Analgesia, Postoperative. Basic parameters: 24 months — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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).

Interventions

  • 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 o
  • 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
  • Procedure control group C
    will receive standard general anesthesia with pain management protocol without regional block.

Primary outcome measures

  • The total amount of rescue analgesia (Ibuprofen consumption) [Time frame: for 24 hours postoperative]
Secondary outcome measures (5)
  • Pain intensity at rest (static) and after movement or coughing (dynamic) [Time frame: 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) [Time frame: for 24 hours postoperative]
  • The total number of patients requiring additional dose of intraoperative fentanyl. [Time frame: during operation period]
  • To record the incidence of complications [Time frame: 24 hours postoperative]
  • Over all parent's satisfaction [Time frame: 24 hours postoperative]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 2 centers
  • faculty of human medicine, Zagazig university hospitals — El Sharkia
  • Faculty of Human Medicine, Zagazig University — El Sharkia

Identifiers

NCT: NCT06752252 · 866

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗