Clinical trial NCT06752252: Ultrasound Guided Paravertebral Block Versus Erector Spinae Block for Postoperative Analgesia After Inguinal Hernia Repair in Pediatric Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Analgesia, Postoperative
Keywords: postoperative analgesia
ultrasound guided paravertebral block
ultrasound guided erector spinae plane block
inguinal hernia repair in pediatric
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-12-30
Enrollment: 158
Sex: ALL
Minimum age (years): 24
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Postoperative analgesia after inguinal hernia repair in pediatric by ultrasound guided paravertebral block or erector spinae block
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: The total amount of rescue analgesia (Ibuprofen consumption)
timeFrame: for 24 hours postoperative
Secondary outcomes:
measure: Pain intensity at rest (static) and after movement or coughing (dynamic)
timeFrame: 0 minutes immediate postoperative ( on arrival to PACU), 30 minutes, 1hs, 2hs, 4hs, 8hs, 12 hrs and 24hs postoperatively
measure: The time to first request of rescue analgesia (Ibuprofen)
timeFrame: for 24 hours postoperative
measure: The total number of patients requiring additional dose of intraoperative fentanyl.
timeFrame: during operation period
measure: To record the incidence of complications
timeFrame: 24 hours postoperative
measure: Over all parent's satisfaction
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: El sharkia
country: Egypt
facility: faculty of human medicine, Zagazig university hospitals
city: El sharkia
country: Egypt
facility: Faculty of Human Medicine, Zagazig University
Study officials:
References: