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Completed

NCT Number: NCT06563622

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

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.

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Key information

Conditions

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

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samar Rafik Mohamed Amin

Banhā, Qalyubia Governorate, 13511, Egypt

About this study

Regional anesthesia is often used to prevent postoperative pain in pediatric surgery. Combined with general anesthesia (GA), ultrasound (US)-guided regional anesthetic approaches provide simple intraoperative pathway that reduced GA requirements, lower pain score with less impact on the respiratory or cardiovascular system

In pediatric surgery, caudal block (CB) is a low-cost, simple, and effective procedure for postoperative analgesia. CB is suggested for most surgeries in the lower body, primarily below the umbilicus. Although the well-established anesthetic properties of CB, its action terminates early in the postoperative period and it has a number of restrictions, such as anatomical abnormalities or infection at the injection site, that can prevent its use

PENG block is the plane lying between the psoas muscle and tendon and the ilio-pubic eminence. The single-shot PENG block has lately been reported in the cadaveric study and in the literature for perioperative pain management in hip surgery by aiming the articular arms of the accessory obturator nerve (AON), femoral nerve (FN), and obturator nerve (ON). The technical simplicity of imaging in traction-fixed patients and no need for multiple punctures made this blockage ideal for young pediatric patients. Unfortunately, there are no adequate studies regarding PENG block in patients younger than five years old.

This study was carried out to assess ultrasound-guided PENG block versus CB for their efficacy, safety and pain management in pediatric hip surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Pericapsular Nerves Group Block

Procedure

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

Other names: PENG Block

Caudal Epidural Block

Procedure

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

Other names: CEB

Primary outcomes

  1. pain score with FLACC

    Time frame: 30 minutes postoperative, 1 hour postoperative, 2 hour postoperative, and 6 hours postoperative

    (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).

Secondary outcomes

  1. The duration of the block

    Time frame: immediately after the intervention, up to 24 hours postoperative

    from immediately after the block administration until the first postoperative rescue analgesia.

  2. the Time to first postoperative rescue analgesia

    Time frame: 24 hours postoperative

    it will be administered if the FLACC score is ≥ 4/10.

  3. Total rescue analgesia consumption

    Time frame: 24 hours postoperative

    total dose of Morphine administrated as rescue opioid

  4. The incidence of postoperative adverse effects

    Time frame: 24 hours postoperative

    including nausea , vomiting , localized hematoma, bradycardia, hypo-tension, and Pruritis.

  5. Parents satisfaction score

    Time frame: 24 hours postoperative

    using a 5- point Likert score (0 = very dissatisfied, 1=dissatisfied, 2 = neither satisfied nor dissatisfied, 3 = satisfied and 4 = very satisfied)

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Ultrasound-Guided Pericapsular Nerve Group Block Versus Ultrasound-Guided Caudal Block for Postoperative Pain Management in Pediatric Hip Surgery; a Randomized Controlled Trail

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2024
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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