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Hip DysplasiaNCT06130761

Pericapsular Block Versus Trans Muscular Quadratus Lumborum Block in Patients Undergoing Correction of Hip Dysplasia

A study testing Pericapsular Nerve Group Block Combined With Lateral Femoral Cutaneous Nerve Block and trans muscular quadratus lumborum block in people with Hip Dysplasia, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 6 months to 6 years
Conditions the study is for
Hip Dysplasia
What is being tested?
Pericapsular Nerve Group Block Combined With Lateral Femoral Cutaneous Nerve Block and trans muscular quadratus lumborum block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
4 Apr 2023to 4 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Anesthesia Department, Kasralainy Faculty of Medicine, Cairo University.

    Cairo, 1772

Other trials in Egypt

About this study

Official title: 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

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

Read the 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.

In TQL block group:

With the patient in the lateral 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 probe is used to recognize the three layers of abdominal wall muscles. The transversus abdominis is traced more posteriorly until the transversus aponeurosis appears. At this region, usually we can find the peritoneum curves away from the muscles from anterior to posterior and the retroperitoneal fat is visualized. 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.

In both groups The surgical stimulus will be delayed 15 minutes in both groups. Intraoperative hemodynamics will be recorded at 10minute intervals. If heart rate (HR) increases more than 20% an additional dose of fentanyl 1 µg/kg will be given.

By the end of surgery, inhalational anesthesia will be discontinued and muscle relaxation will be reversed by atropine (0.02 mg/Kg) and neostigmine (0.05 mg/Kg) after the restoration of the patient's spontaneous breathing. The patient will be transferred to the post-anesthesia care unit (PACU) for 2 hours to complete recovery and monitoring. Quality of analgesia will be assessed using (face, legs, activity, and cry consolability scale) (FLACC) pain score18 on admission to PACU and then every 15 minutes for 2 hours. After transfer to the ward, FLACC pain score will be recorded at 3, 6, 12, and 24 hours postoperative.

All patients will receive postoperative diclofenac sodium suppositories 1 mg/kg approximated to available form 12.5 or 25 mg suppository every 8 hours. Morphine IV will be given as rescue analgesia (0.05 mg/kg) in all study groups; if the FLACC pain score (Table 1) is more than 4, the maximum allowed dose will be 0.1mg/kg every 4 hours.

Any complications resulting from peripheral nerve blockade, like local anesthetic systemic toxicity, bleeding, infection or neuropathy, will be recorded and managed accordingly.

Conditions
Hip Dysplasia
Being tested
Pericapsular Nerve Group Block Combined With Lateral Femoral Cutaneous Nerve Block, trans muscular quadratus lumborum block
Keywords
quadratus lumborum blocks
Medical subject headings
Hip Dislocation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pericapsular Nerve Group Block Combined With Lateral Femoral Cutaneous Nerve BlockProcedure or surgery

    Also called PENG block

    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.

  • trans muscular quadratus lumborum blockProcedure or surgery

    Also called TQL block

    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.

Study groups in NCT06130761
Study groupRoleWhat they receive
PENG block (P group)ExperimentalPENG 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 .
Receives: Procedure: Pericapsular Nerve Group Block Combined With Lateral Femoral Cutaneous Nerve Block
TQL block (Q group)ExperimentalQL 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
Receives: Procedure: trans muscular quadratus lumborum block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first rescue analgesia .

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

    Measured: 15 minutes after extubation for 24 hours postoperative

Secondary outcomes (4)
  1. Postoperative (FLACC)Face, Legs, Activity, Cry, Consolability scale.

    Postoperative FLACC pain scores with 0 minimum pain and 10 maximum pain

    Measured: 15 minutes after extubation for 24 hours postoperative

  2. Total intraoperative analgesic (fentanyl) requirements

    Total amount of analgesics given intraoperative

    Measured: Intraoperative

  3. Total postoperative analgesic requirements

    Total amount of analgesics given postoperative

    Measured: 15 minutes after extubation for 24 hours postoperative

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

    measuring and recording vitals every 10 minutes

    Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2023
  2. Study start4 Apr 2023
  3. Primary completion11 Mar 2024
  4. Study completion4 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06130761
Sponsor's protocol ID
MD-302-2022
Status last verified
Nov 2023
First submitted
9 Apr 2023
Last updated
31 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Pericapsular Nerve Group Block Combined With Lateral Femoral Cutaneous Nerve Block and trans muscular quadratus lumborum block in people with Hip Dysplasia, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first rescue analgesia . (time frame: 15 minutes after extubation for 24 hours postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.

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