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

July 25, 2023 updated by: Ahmed Ismail Elnaggar, Alexandria University

Comparing the Postoperative Analgesic Effect of Fascia Transversalis Plane Block Versus Pericapsular Nerve Group Block for Hip Surgery in Pediatrics: A Randomized Controlled Clinical Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During the pre-anesthesia check-up visit, the proposed intervention will be discussed with the eligible participant's parents or caregivers including data about the aim, the advantages, and the expected side effects, and then a detailed written informed consent will be obtained before recruitment and randomization.

All participants will be premedicated with 0.5mg/kg oral midazolam about 30min before being admitted to the operating room. The routine standard monitoring including electrocardiography (ECG), non-invasive blood pressure (NIBP), pulse oximetry for blood oxygen saturation (SpO2), temperature probe, and end-tidal CO2 (EtCO2) will be applied to all participants. Induction of general anesthesia (GA) will be performed using a face mask with sevoflurane inhalation in oxygen starting with 2% up to 8% till complete loss of consciousness after that peripheral intravenous (IV) line will be secured where fentanyl 1 μg/kg and followed by cisatracurium 0.15mg/kg to facilitate orotracheal intubation. Anesthesia will be maintained by using isoflurane 1.2-1.5% in oxygen air mixture 50%:50% in addition to incremental cisatracurium 0.03mg/kg.

After induction of GA, the eligible participants will be randomly assigned to one of two equal groups either FTPB or PENG block.

In both interventional group participants, the assigned block will be performed after induction of GA by the same investigator who will have no further role in the study. Surgery will be started about 15 minutes after performing the block.

Fentanyl 1μg/ kg will be administrated intraoperatively in the case of inadequate analgesia which is defined as an increase of heart rate (HR) and/or mean arterial blood pressure (MAP) more than 20% above the pre-operative values. At the end of the surgery, isoflurane will be switched off and extubation will be done after reversal of muscle relaxant with neostigmine 0.05 mg/kg and atropine 0.02 mg/kg where the participants will be transferred to the Post-Anesthesia Care Unit (PACU). Paracetamol (15 mg/kg) will be administered IV every 6 hours in all participants.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 6 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the ultrasound-guided fascia transversalis plane block
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
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.
Other Names:
  • Fascia Transversalis Plane Block
Experimental: The ultrasound guided Pericapsular Nerve Group block
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
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
Other Names:
  • Pericapsular Nerve Group block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time until the first rescue analgesic requirement postoperatively
Time Frame: the first postoperative 48 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Study Director: Hisham M Gamal Eldine, MD, Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2022

Primary Completion (Actual)

May 25, 2023

Study Completion (Actual)

July 25, 2023

Study Registration Dates

First Submitted

April 5, 2022

First Submitted That Met QC Criteria

April 21, 2022

First Posted (Actual)

April 27, 2022

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB NO: 00012098, SN: 0305476

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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