- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06563622
Pericapsular Nerve Group Block Versus Caudal Block for Postoperative Pain Management in Pediatric Hip Surgery
Ultrasound-Guided Pericapsular Nerve Group Block Versus Ultrasound-Guided Caudal Block for Postoperative Pain Management in Pediatric Hip Surgery; a Randomized Controlled Trail
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Regional anesthesia is often used to prevent postoperative pain in pediatric surgery. Combined with general anesthesia (GA), ultrasound (US)-guided regional anesthetic approaches provide simple intraoperative pathway that reduced GA requirements, lower pain score with less impact on the respiratory or cardiovascular system
In pediatric surgery, caudal block (CB) is a low-cost, simple, and effective procedure for postoperative analgesia. CB is suggested for most surgeries in the lower body, primarily below the umbilicus. Although the well-established anesthetic properties of CB, its action terminates early in the postoperative period and it has a number of restrictions, such as anatomical abnormalities or infection at the injection site, that can prevent its use
PENG block is the plane lying between the psoas muscle and tendon and the ilio-pubic eminence. The single-shot PENG block has lately been reported in the cadaveric study and in the literature for perioperative pain management in hip surgery by aiming the articular arms of the accessory obturator nerve (AON), femoral nerve (FN), and obturator nerve (ON). The technical simplicity of imaging in traction-fixed patients and no need for multiple punctures made this blockage ideal for young pediatric patients. Unfortunately, there are no adequate studies regarding PENG block in patients younger than five years old.
This study was carried out to assess ultrasound-guided PENG block versus CB for their efficacy, safety and pain management in pediatric hip surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Qalyubia Governorate
-
Banhā, Qalyubia Governorate, Egypt, 13511
- Samar Rafik Mohamed Amin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- child aged 1- 7 years old
- American Society of Anesthesiologists (ASA) physical status I-II
- scheduled for elective hip surgery under general anesthesia
Exclusion Criteria:
- parents/guardians refusal to participate
- known local anesthetic drug sensitivity,
- bleeding disorders,
- pre-existing infection at the block site, and
- the presence of major cardiac, renal, or hepatic disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group P
In ultrasound-guided pericapsular nerve group block Group , the patient will be positioned in a supine position.
The anatomical landmarks, including ilio-pubic eminence, the iliopsoas muscle and tendon, the femoral artery and vein, and the pectineus muscle, will be identified using a 9-12 MHz superficial linear transducer.
A lateral to medial in-plane technique will be used to insert a 22-gauge, 50-mm needle.
the needle's tip will be positioned at the musculofascial plane, located between the ilio-pubic ramus posteriorly and the psoas tendon anteriorly.
Following negative aspiration to avoid intravascular injection, 0.5-1 ml of normal saline will be injected to confirm the correct needle site.
A 0.5 ml/kg plain bupivacaine 0.25% will be injected.
|
USG-guided single-shot PENG in a dose of 0.5 ml/kg of 0.25% bupivacaine per side.
Other Names:
|
|
Active Comparator: Group C
the caudal epidural block will be established in the lateral decubitus position, the high-frequency linear transducer will be first placed transversely at the midline to obtain a "frog eye" sign view of the sacral cornu, the sacro-coccygeal ligament, the sacrum, and the sacral hiatus.
At this position, the USG transducer will be rotated by 90° to obtain a longitudinal view.
The needle will be inserted in-plane into the sacral canal and the Local anaesthetics will be injected under real-time visualization by a dose of 0.5 ml/kg plain bupivacaine 0.25%.
|
USG-guided single-shot CEB in a dose of 0.5 mL/kg of 0.25% bupivacaine.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain score with FLACC
Time Frame: 30 minutes postoperative, 1 hour postoperative, 2 hour postoperative, and 6 hours postoperative
|
(Face, Legs, Activity, Cry, and Consolability scale to assess pain in young children.
Each category is scored on a 0-2 scale which results in a total score between 0 (lowest pain) and 10 (worst pain).
|
30 minutes postoperative, 1 hour postoperative, 2 hour postoperative, and 6 hours postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The duration of the block
Time Frame: immediately after the intervention, up to 24 hours postoperative
|
from immediately after the block administration until the first postoperative rescue analgesia.
|
immediately after the intervention, up to 24 hours postoperative
|
|
the Time to first postoperative rescue analgesia
Time Frame: 24 hours postoperative
|
it will be administered if the FLACC score is ≥ 4/10.
|
24 hours postoperative
|
|
The incidence of postoperative adverse effects
Time Frame: 24 hours postoperative
|
including nausea , vomiting , localized hematoma, bradycardia, hypo-tension, and Pruritis.
|
24 hours postoperative
|
|
Parents satisfaction score
Time Frame: 24 hours postoperative
|
using a 5- point Likert score (0 = very dissatisfied, 1=dissatisfied, 2 = neither satisfied nor dissatisfied, 3 = satisfied and 4 = very satisfied)
|
24 hours postoperative
|
|
Total rescue analgesia consumption
Time Frame: 24 hours postoperative
|
total dose of Morphine administrated as rescue opioid
|
24 hours postoperative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC.30.9.2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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