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Clinical Trials/NCT06563622
NCT06563622
Completed
Not Applicable

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

Benha University1 site in 1 country80 target enrollmentAugust 10, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Postoperative
Sponsor
Benha University
Enrollment
80
Locations
1
Primary Endpoint
pain score with FLACC
Status
Completed
Last Updated
5 months ago

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 10, 2024
End Date
April 20, 2025
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Samar Rafik Mohamed Amin

Assistant professor of anaesthesia and intensive care

Benha University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • 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 Sites (1)

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