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

Zagazig University

Status: Enrolling

Conditions: Analgesia, Postoperative

Treatments: Procedure: Ultrasound guided erector spinae plane block; Procedure: control group C; Procedure: ultrasound guided paravertebral block

Study type: Interventional

Funder types: Other

Identifiers

NCT06752252

866

Details and patient eligibility

About

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.

Full 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).

Enrollment: 158 estimated patients

Sex: All

Ages: 24 months to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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158 participants in 3 patient groups

Group paravertebral (PVB) block

Active Comparator group

Description:

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

Treatment:

Procedure: ultrasound guided paravertebral block

Group erector spinae plane (ESP) block

Active Comparator group

Description:

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

Treatment:

Procedure: Ultrasound guided erector spinae plane block

Control group (group C)

Active Comparator group

Description:

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.

Treatment:

Procedure: control group C