NCT06130761

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2023

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2024

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2024

Completed
Last Updated

May 31, 2025

Status Verified

November 1, 2023

Enrollment Period

11 months

First QC Date

April 9, 2023

Last Update Submit

May 27, 2025

Conditions

Keywords

quadratus lumborum blocks

Outcome Measures

Primary Outcomes (1)

  • Time to first rescue analgesia .

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

    15 minutes after extubation for 24 hours postoperative

Secondary Outcomes (4)

  • Postoperative (FLACC)Face, Legs, Activity, Cry, Consolability scale.

    15 minutes after extubation for 24 hours postoperative

  • Total intraoperative analgesic (fentanyl) requirements

    Intraoperative

  • Total postoperative analgesic requirements

    15 minutes after extubation for 24 hours postoperative

  • Intraoperative hemodynamics every 10minutes heart rate, systolic, diastolic, mean arterial blood pressure

    Intraoperative

Study Arms (2)

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 .

Procedure: Pericapsular Nerve Group Block Combined With Lateral Femoral Cutaneous Nerve Block

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

Procedure: trans muscular quadratus lumborum block

Interventions

For PENG block 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 then 0.5 ml/kg of 0.25% bupivacaine is deposited between the psoas tendon anteriorly and pubic ramus posteriorly lifting it. For LFCN 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 appears 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" may be felt as the needle tip enters the plane.

Also known as: PENG block
PENG block (P group)

With the patient in the lateral position, after standard sterilization of skin and probe identify 3 layers of the abdomen. The transversus abdominis is traced more posteriorly until the transversus aponeurosis. usually we can find the peritoneum curves away from the muscles from anterior to posterior . Tilting the probe slightly caudal into the pelvis thus improves the view of the retroperitoneal fat and the tapered end of transversus aponeurosis. 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.

Also known as: TQL block
TQL block (Q group)

Eligibility Criteria

Age6 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesia Department, Kasralainy Faculty of Medicine, Cairo University.

Cairo, 1772, Egypt

Location

MeSH Terms

Conditions

Hip Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesHip Injuries

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 Lecturer of Anesthesiology, Surgical ICU and Pain management

Study Record Dates

First Submitted

April 9, 2023

First Posted

November 14, 2023

Study Start

April 4, 2023

Primary Completion

March 11, 2024

Study Completion

April 4, 2024

Last Updated

May 31, 2025

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations