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Clinical Trials/NCT06130761
NCT06130761CompletedNot Applicable

Pericapsular Nerve Group Block Combined Versus Trans Muscular Quadratus Lumborum Block in Pediatric Patients Undergoing Correction of Dysplasia of the Hip: a Prospective Randomized Double Blinded Study

Cairo University1 site in 1 country50 target enrollmentStarted: April 4, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Time to first rescue analgesia .

Study Overview

Brief Summary

The aim of our study to compare the analgesic effect of pericapsular nerve group block combined with lateral femoral cutaneous nerve block and trans muscular quadratus Lumborum Block block perioperatively in pediatric patients undergoing developmental dysplasia of the hip surgical repair

Detailed Description

Patients of both study groups will be monitored using standard monitors Electrocardiogram, pulse oximeter and automated non-invasive blood pressure (NIBP). After preoxygenation, general anesthesia will be induced by a face mask and 8% sevoflurane and 100 % oxygen, then intravenous cannula will be inserted. Fentanyl 1 µg/kg will be given and after neuromuscular block is achieved with atracurium 0.5 mg/kg and the trachea is intubated. Anesthesia will be maintained with isoflurane 1.2% and 60% oxygen and the maintenance dose of atracurium 0.1 mg/kg each 20 minutes. Ringer lactate will be infused at 10 ml/kg per hour in first hour then by the rule 4-2-1 ml per kg per hour.

The blocks will be performed after induction of anesthesia and under ultrasound guidance using SonoSite M Turbo (USA); the scanning probe will be the linear multi-frequency 6-13 MHz transducer (L25 x 6-13 MHz linear array).

Patients will be randomly allocated into two equal groups: PENG block (P group) and TQL block (Q group).

In PENG block group:

With the patient in the supine position, the skin is disinfected, sterile drapes are used, the transducer is wrapped with a sterile dressing, and sterile ultrasound gel is used for scanning, the transducer is placed in the transverse plane over the anterior inferior iliac spine (AIIS) and moved inferiorly to visualize the pubic ramus. The femoral artery and iliopubic eminence are visualized, and then, using an in-plane technique, a 22-gauge 50 mm needle is advanced from lateral to medial through the skin wheal at a 30-degree to 45-degree angle toward the ultrasound beam, Aspiration will be performed before injection, then 0.5 ml/kg of 0.25% bupivacaine is deposited between the psoas tendon anteriorly and pubic ramus posteriorly lifting it .16 To perform the LFCN block: again, the patient in supine position, the skin is disinfected, sterile drapes are used, the transducer is wrapped with a sterile dressing, and sterile ultrasound gel is used for scanning, the transducer is placed immediately inferior to the anterior superior iliac spine (ASIS), parallel to the inguinal ligament. The tensor fasciae lata muscle (TFLM) and sartorius muscle (SaM) are then identified. The nerve should appear as a small hypoechoic oval structure with a hyperechoic rim between the TFLM and SaM in a short-axis view or superficial to the SaM. A 22-gauge 50 mm needle is inserted in-plane in a lateral-to-medial orientation through the subcutaneous tissue. A fascial "pop" or "click" may be felt as the needle tip enters the plane between the TFLM and SaM. To identify the needle tip position, a volume of 0.5-1 mL of isotonic saline may be injected. The correct position is achieved by visualizing the spread of 0.1 ml/kg of 0.25% bupivacaine in the described plane between the TFLM and SaM or around the LFCN superficial to the SaM.9 The dose of bupivacaine in both blocks should not exceed 2.5mg per kg as they will be administrated in the same patient.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
6 Months to 6 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Acceptance of the parents
  • •Children of both gender
  • •ASA I & ASA II
  • •Age ranging between 6 months up to 6years old (neglected cases)
  • •Scheduled to DDH surgical repair (open reduction or osteotomy) either unilateral or bilateral.
  • •Revision cases.

Exclusion Criteria

  • •Parent refusal
  • •ASA III, IV
  • •Infection at site of block
  • •History of allergy to local anesthetics
  • •Bleeding disorders with INR > 1.5 and/or platelets < 100,000/mm3

Arms & Interventions

PENG block (P group)

Experimental

PENG BLOCK : 0.5 ml/kg of 0.25% bupivacaine is deposited between the psoas tendon anteriorly and pubic ramus posteriorly lifting it , and to perform the LFCN block 0.1 ml/kg of 0.25% bupivacaine is injected in lateral to femoral artery below anterior superior iliac spine .

Intervention: Pericapsular Nerve Group Block Combined With Lateral Femoral Cutaneous Nerve Block (Procedure)

TQL block (Q group)

Experimental

QL is usually identified medial to the aponeurosis of transversus abdominis muscle vertically attached above the iliac crest. A 22-gauge 50 mm needle will be inserted in the plane from the posterior edge of the convex probe through the QL in an anteromedial direction. The needle tip will be placed between the PM muscle and the QL muscle and the local anesthetic will be injected into the fascial plane after aspiration test is negative. A volume 0.5 ml/kg of 0.25% bupivacaine is injected with maximum dose 2.5mg per kg of bupivacaine

Intervention: trans muscular quadratus lumborum block (Procedure)

Outcomes

Primary Outcomes

Time to first rescue analgesia .

Time Frame: 15 minutes after extubation for 24 hours postoperative

Time to first rescue analgesia 15 minutes after extubating the patient .

Secondary Outcomes

  • Postoperative (FLACC)Face, Legs, Activity, Cry, Consolability scale.(15 minutes after extubation for 24 hours postoperative)
  • Intraoperative hemodynamics every 10minutes heart rate, systolic, diastolic, mean arterial blood pressure(Intraoperative)
  • Total intraoperative analgesic (fentanyl) requirements(Intraoperative)
  • Total postoperative analgesic requirements(15 minutes after extubation for 24 hours postoperative)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aliaa Helmy Mohammed Mohammed

Assistant Lecturer of Anesthesiology, Surgical ICU and Pain management

Cairo University

Study Sites (1)

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