Pericapsular Nerve Group Block Versus Caudal Block for Postoperative Pain Management in Pediatric Hip Surgery

NCT06563622 | Completed

• 1 other identifier: RC.30.9.2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Children can experience substantial pain after hip operations, causing agitation, depression, and sleep disruption, which can have a negative impact on their health. Opioids are associated with several serious side effects that limits its use as solo agents for pain management. Regional blocks such as caudal Block (CB) and pericapsular nerve group (PENG) block in adjuvant with general anaesthesia are alternative perioperative analgesic techniques that lead to lesser side effects, including motor weakness, postoperative nausea and vomiting with decreased opioid consumption.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• pain score with FLACC

  (Face, Legs, Activity, Cry, and Consolability scale to assess pain in young children. Each category is scored on a 0-2 scale which results in a total score between 0 (lowest pain) and 10 (worst pain).

  30 minutes postoperative, 1 hour postoperative, 2 hour postoperative, and 6 hours postoperative

Secondary Outcomes (5)

• The duration of the block

  immediately after the intervention, up to 24 hours postoperative

• the Time to first postoperative rescue analgesia

  24 hours postoperative

• Total rescue analgesia consumption

  24 hours postoperative

• The incidence of postoperative adverse effects

  24 hours postoperative

• Parents satisfaction score

  24 hours postoperative

Study Arms (2)

Group P

EXPERIMENTAL

In ultrasound-guided pericapsular nerve group block Group , the patient will be positioned in a supine position. The anatomical landmarks, including ilio-pubic eminence, the iliopsoas muscle and tendon, the femoral artery and vein, and the pectineus muscle, will be identified using a 9-12 MHz superficial linear transducer. A lateral to medial in-plane technique will be used to insert a 22-gauge, 50-mm needle. the needle's tip will be positioned at the musculofascial plane, located between the ilio-pubic ramus posteriorly and the psoas tendon anteriorly. Following negative aspiration to avoid intravascular injection, 0.5-1 ml of normal saline will be injected to confirm the correct needle site. A 0.5 ml/kg plain bupivacaine 0.25% will be injected.

Procedure: Pericapsular Nerves Group Block

Group C

ACTIVE COMPARATOR

the caudal epidural block will be established in the lateral decubitus position, the high-frequency linear transducer will be first placed transversely at the midline to obtain a "frog eye" sign view of the sacral cornu, the sacro-coccygeal ligament, the sacrum, and the sacral hiatus. At this position, the USG transducer will be rotated by 90° to obtain a longitudinal view. The needle will be inserted in-plane into the sacral canal and the Local anaesthetics will be injected under real-time visualization by a dose of 0.5 ml/kg plain bupivacaine 0.25%.

Procedure: Caudal Epidural Block

Interventions

Pericapsular Nerves Group Block PROCEDURE

USG-guided single-shot PENG in a dose of 0.5 ml/kg of 0.25% bupivacaine per side.

Also known as: PENG Block

Group P

Caudal Epidural Block PROCEDURE

USG-guided single-shot CEB in a dose of 0.5 mL/kg of 0.25% bupivacaine.

Also known as: CEB

Group C

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• child aged 1- 7 years old
• American Society of Anesthesiologists (ASA) physical status I-II
• scheduled for elective hip surgery under general anesthesia

You may not qualify if:

• parents/guardians refusal to participate
• known local anesthetic drug sensitivity,
• bleeding disorders,
• pre-existing infection at the block site, and
• the presence of major cardiac, renal, or hepatic disorders.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Samar Rafik Mohamed Amin

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of anaesthesia and intensive care

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 21, 2024
• Study Start: August 10, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 20, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)