- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07617545
External Oblique Intercostal Plane Block Versus Erector Spinae Plane Block in Paediatric Upper Abdominal Surgeries
Ultrasound Guided External Oblique Intercostal Plane Block Versus Erector Spinae Plane Block in Paediatric Upper Abdominal Surgeries
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Paediatric nerve blocks are increasingly recognized as new standard for managing pain in children. The advantages of regional anesthesia in this population include enhanced operating conditions, expedited recovery of bowel function, and reduced postoperative pain.
The caudal epidural block remains the most used method; however, the external oblique intercostal block, a novel technique involves administering local anesthesia deep to the external oblique muscle at the sixth intercostal space, thereby blocking thoracoabdominal nerves from T6 to T10. This technique offers several advantages, including straightforward anatomy, a single muscle strip that is easily identifiable even in obese patients, a bony backstop, and an easily expandable fascial plane that can accommodate a catheter.
The erector spinae plane block involves injecting local anesthetic into the fascial plane beneath the erector spinae muscle at the tip of the vertebral transverse process. This allows the local anesthetic to spread in the craniocaudal fascial plane.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Belal M Hassan, MBBCH
- Phone Number: 00201091397908
- Email: Belal.bakr1420@alexmed.edu.eg
Study Locations
-
-
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Alexandria, Egypt, 21526
- Recruiting
- Alexandria University
-
Contact:
- Belal M Hassan, MBBCH
- Phone Number: 00201091397908
- Email: Belal.bakr1420@alexmed.edu.eg
-
Sub-Investigator:
- Wafaa M Shafshak, MD
-
Sub-Investigator:
- Ola M Zanaty, MD
-
Sub-Investigator:
- Mohamed W Nassar, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children aged between 6 and 12 years of both sex.
- Patients with the American Society of Anesthesiologists (ASA) physical status I/II.
- Patients undergoing upper abdominal surgeries involving upper abdominal incisions.
Exclusion Criteria:
- Guardian refusal.
- Allergy to local anesthetics.
- Surgical procedures exceeding 3 hours.
- Infection at the area planned for the block injection.
- Prolonged opioid medication.
- Patients preoperatively medicated by Beta blockers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group I
Patients will receive ultrasound-guided external oblique intercostal plane block.
|
Patients will receive ultrasound-guided external oblique intercostal plane block.
|
|
Experimental: Group II
Patients will receive ultrasound-guided erector spinae plane block.
|
Patients will receive ultrasound-guided erector spinae plane block.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of pain
Time Frame: 12 hours after surgery
|
Postoperative pain will be assessed using Faces pain score revised. The Faces Pain Scale revised (FPS-R) is a validated self-report instrument designed to measure pain intensity in pediatric populations. The scale comprises a series of facial expressions, ranging from a smiling face at 0, indicating "no pain," to a crying face at 10, indicating "very much pain". Children are instructed to select the face that most accurately reflects their current pain level. The faces are scored (0, 2, 4, 6, 8, 10), providing a quantifiable measure of pain intensity. |
12 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate
Time Frame: Every 15 minutes intraoperative
|
Heart rate will be recorded preoperative basal readings, after induction of anesthesia, during skin incision, and every 15 minutes intraoperative.
|
Every 15 minutes intraoperative
|
|
Mean arterial blood pressure
Time Frame: Every 15 minutes intraoperative
|
Mean arterial blood pressure will be recorded preoperative basal readings, after induction of anesthesia, during skin incision, and every 15 minutes intraoperative.
|
Every 15 minutes intraoperative
|
|
Peripheral oxygen saturation
Time Frame: Every 15 minutes intraoperative
|
Peripheral oxygen saturation will be recorded preoperative basal readings, after induction of anesthesia, during skin incision, and every 15 minutes intraoperative.
|
Every 15 minutes intraoperative
|
|
Duration of analgesia
Time Frame: 12 hours after surgery
|
Duration of analgesia will be recorded from block completion till first postoperative rescue analgesia requirement.
|
12 hours after surgery
|
|
Total rescue analgesia requirement
Time Frame: 12 hours after surgery
|
In Faces Pain Scale score-revised, cut of points for analgesic requirement is ≧ 4, rescue analgesia will be administered in the form of nalbuphine 0.1 mg/kg, with a maximum dose of 0.2 mg/kg.
|
12 hours after surgery
|
|
Incidence of complications
Time Frame: 12 hours after surgery
|
Incidence of complications including hematomas block failure, intravascular injection, pneumothorax or injection into the peritoneal cavity, with associated risks of damage to bowel and other abdominal viscera at the block site will be recorded.
|
12 hours after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- 00012098 (0109306)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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