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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
FTPB
PENG Block
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring Fascia Transversalis plane block, pericapsular nerve group block, developmental dysplasia of the hip, postoperative analgesia, pediatric, hip surgery

Eligibility Criteria

1 Year - 6 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

the ultrasound-guided fascia transversalis plane block

The ultrasound guided Pericapsular Nerve Group block

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 5, 2022
Last Updated
July 25, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05348421
Brief Title
Postoperative Analgesic Effect of Two Peripheral Nerve Blocks for Hip Surgery in Pediatrics
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 6, 2022 (Actual)
Primary Completion Date
May 25, 2023 (Actual)
Study Completion Date
July 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the ultrasound-guided fascia transversalis plane block
Arm Type
Experimental
Arm Description
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.
Arm Title
The ultrasound guided Pericapsular Nerve Group block
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
FTPB
Other Intervention Name(s)
Fascia Transversalis Plane Block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
PENG Block
Other Intervention Name(s)
Pericapsular Nerve Group block
Intervention Description
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
Primary Outcome Measure Information:
Title
The time until the first rescue analgesic requirement postoperatively
Description
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.
Time Frame
the first postoperative 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hisham M Gamal Eldine, MD
Organizational Affiliation
Alexandria University
Official's Role
Study Director
Facility Information:
Facility Name
Alexandria University
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Postoperative Analgesic Effect of Two Peripheral Nerve Blocks for Hip Surgery in Pediatrics

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