Postoperative Analgesic Effect of Two Peripheral Nerve Blocks for Hip Surgery in Pediatrics

NCT05348421 | Completed

• 1 other identifier: IRB NO: 00012098, SN: 0305476
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Hip joint surgery for developmental dysplasia of the hip (DDH) in children is extremely painful and associated with considerable postoperative pain despite the use of systemic opioids. Caudal anesthesia and lumbar plexus block (LPB) were still the most common regional anesthesia techniques for perioperative analgesia in children undergoing this type of surgery. recently, pediatric anesthesiologists don't consider choosing both techniques because of potential complications such as intravascular and intrathecal injection, and urine retention. novel peripheral nerve blocks have been advocated in pediatrics to avoid the aforementioned complications such as PEricapsular Nerve Group (PENG) block, Quadratus Lumborum Block (QLB), and Fascia Transversalis Plane Block (FTPB) The objective of the current study is to assess the analgesic efficacy of ultrasound-guided FTPB versus ultrasound-guided PENG block in pediatric patients undergoing open hip surgery for DDH

Conditions

Pain, Postoperative; Developmental Dysplasia of the Hip; Regional Anesthesia Morbidity

Keywords

Fascia Transversalis plane block; pericapsular nerve group block; developmental dysplasia of the hip; postoperative analgesia; pediatric; hip surgery

Outcome Measures

Primary Outcomes (1)

• The time until the first rescue analgesic requirement postoperatively

  Postoperative pain will be assessed by Face, leg, activity, cry, consolability (FLACC) score by the attending physician either in the PACU or in the surgical ward which ranges from a minimum score of zero (relaxed \& comfortable) to a maximum of 10 (severe discomfort \&pain). Morphine IV 0.1 mg/kg will be given as rescue analgesia if the FLACC score will be more than 3.

  the first postoperative 48 hours

Study Arms (2)

the ultrasound-guided fascia transversalis plane block

EXPERIMENTAL

The TFPB will be performed while the participant is in the supine position. a high-frequency linear ultrasound probe (5-13 MHz) will be placed transversely in the midaxillary line between the iliac crest and the costal margin. After the external oblique, internal oblique, transversus abdominis muscle, and quadratus lumborum (QL) muscle will be identified.

Procedure: FTPB

The ultrasound guided Pericapsular Nerve Group block

EXPERIMENTAL

while the participant is in the supine position, a linear ultrasound probe will be initially placed in a transverse plane over the anterior inferior iliac spine (AIIS) and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees; In this view, the ilio-pubic eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be observed.

Procedure: PENG Block

Interventions

FTPB PROCEDURE

A 22-gauge needle will be advanced from anterior using an in-plane technique and passed through the posterior 'tail' of the transversus muscle. the local anesthetic solution of 0.25% bupivacaine will be injected for a total volume of 0.5 ml/kg will be injected to separate the transversalis fascia from the transversus muscle.

Also known as: Fascia Transversalis Plane Block

the ultrasound-guided fascia transversalis plane block

PENG Block PROCEDURE

A 22-gauge, 80-mm needle will be inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly where the local anesthetic solution of 0.25% bupivacaine will be injected for a total volume of 0.5 ml/kg

Also known as: Pericapsular Nerve Group block

The ultrasound guided Pericapsular Nerve Group block

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• American society association (ASA) physical status class I - II.
• Participants who will be scheduled for an elective unilateral open hip surgery for correction of DDH under general anesthesia.

You may not qualify if:

• Participants with respiratory disease, renal or hepatic insufficiency.
• Infection of the skin in the puncture area.
• Coagulopathy.
• Allergy against any of the drugs to be used (bupivacaine).
• Neuromuscular disease.
• Obesity (body mass index, BMI \>30).
• Bilateral hip surgery or previous hip surgery.
• Previous analgesic medication or chronic pain under treatment.
• previously known neurological pathologies or central nervous system disorders.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University

Alexandria, Egypt

Location

Related Publications (17)

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MeSH Terms

Conditions

Pain, Postoperative; Developmental Dysplasia of the Hip

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Hip Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Hisham M Gamal Eldine, MD

  Alexandria University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 27, 2022
• Study Start: May 6, 2022
• Primary Completion: May 25, 2023
• Study Completion: July 25, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)