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Clinical Trials/NCT06417268
NCT06417268
Recruiting
Phase 2

Ultrasound-Guided Combined Pericapsular Nerve Group Block and Lateral Femoral Cutaneous Nerve Block Versus Caudal Block for Postoperative Analgesia in Pediatric Hip Surgeries. A Randomized Controlled Study.

Kasr El Aini Hospital1 site in 1 country68 target enrollmentMarch 1, 2024

Overview

Phase
Phase 2
Intervention
Caudal epidural analgesia
Conditions
Pericapsular Nerve Group Block
Sponsor
Kasr El Aini Hospital
Enrollment
68
Locations
1
Primary Endpoint
Time to first rescue analgesia
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

combined pericapsular nerve group PENG block and lateral femoral cutaneous nerve block may be effective in reducing post-operative pain after open hip surgery in children.

Detailed Description

All children will be assessed clinically, and investigations will be done to exclude the exclusion criteria mentioned above. Laboratory works needed: complete blood count (CBC), prothrombin time, concentration, partial thromboplastin time. Midazolam (0.5mg/kg) will be given orally to each child in both groups as a premedication half an hour before the procedure. General anesthesia will be induced in a supine position under standard basic monitoring of vital signs with inhalational anesthetic using (100%) O2 + Sevoflurane. Group C will receive caudal analgesia Bupivacaine 0.25% at a dose of 1 ml/kg. Group B will receive PENG block Bupivacaine 0.25% at a dose of 1 ml/kg and lateral femoral cutaneous nerve block Bubivacaine 0.25% at 0.1 ml/kg. After receiving the block, a surgical incision will be done after 15 minutes. Continuous recording of heart rate and blood pressure will be carried out from the moment of injection at timely intervals intra-operative. Intra-operatively, an increase in hemodynamics in response to the skin incision by more than 30% from baseline values 5 min after intubation or thereafter is managed by intravenous administration of fentanyl 1 µg/kg to a maximum dose of 2 µg/kg. Postoperative pain assessment using the FLACC score will then follow for 24 hours.

Registry
clinicaltrials.gov
Start Date
March 1, 2024
End Date
August 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kasr El Aini Hospital
Responsible Party
Principal Investigator
Principal Investigator

maged gamal

Anesthesia lecturer

Kasr El Aini Hospital

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologists (ASA) physical status I, II.
  • Unilateral hip surgery.

Exclusion Criteria

  • Parents' refusal to participate in the study.
  • Coagulopathy (i.e. Platelets ≤ 50,000 and/or INR\> 1.5).
  • Localized infection at the site of needle insertion.
  • Known hypersensitivity or allergies to any of the used drugs.
  • Bilateral hip surgery in the same session.

Arms & Interventions

Group C

Patients will receive caudal analgesia

Intervention: Caudal epidural analgesia

Group C

Patients will receive caudal analgesia

Intervention: Fentanyl

Group C

Patients will receive caudal analgesia

Intervention: Morphine

Group C

Patients will receive caudal analgesia

Intervention: Acetaminophen

Group B

patients will receive PENG block and Lateral Femoral Cutaneous Nerve block

Intervention: Ultrasound-guided Combined Pericapsular Nerve Group Block

Group B

patients will receive PENG block and Lateral Femoral Cutaneous Nerve block

Intervention: Ultrasound-guided Lateral Femoral Cutaneous Nerve Block

Group B

patients will receive PENG block and Lateral Femoral Cutaneous Nerve block

Intervention: Fentanyl

Group B

patients will receive PENG block and Lateral Femoral Cutaneous Nerve block

Intervention: Morphine

Group B

patients will receive PENG block and Lateral Femoral Cutaneous Nerve block

Intervention: Acetaminophen

Outcomes

Primary Outcomes

Time to first rescue analgesia

Time Frame: First 24 hours postoperative

Time (minutes) to first need of rescue analgesia postoperative.

Secondary Outcomes

  • Intraoperative hemodynamic parameters(intraoperative period)
  • Total fentanyl consumption(intraoperative period)
  • Total morphine consumption(First 24 hours postoperative)
  • Postoperative pain assessment FLACC(First 24 hours postoperative)

Study Sites (1)

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