- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07336043
External Oblique Intercostal Block Versus Transversus Abdominis Plane Block in Pediatric Laparoscopic Splenectomy
Optimizing Regional Analgesia in Pediatric Laparoscopic Splenectomy: External Oblique Intercostal Block Versus Transversus Abdominis Plane Block: Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Optimal postoperative pain control in children is particularly challenging despite advances in multimodal pharmaceutical strategies. Laparoscopic approaches have improved postoperative outcomes when compared to open surgery, particularly in terms of postoperative pain. Pain after laparoscopic surgeries has three components; including incisional, visceral, and referred shoulder pain secondary to peritoneal insufflation. Opioid analgesia can be an effective adjunct to an existing non-opioid pain regimen. However, opioids are known to decrease bowel motility, result in nausea, and cause respiratory depression, particularly in the pediatrics. Traditionally, neuraxial blocks have been used for abdominal surgeries but in patients with low platelet count as splenectomy, this might not be a feasible option.
Effective fascial plane blocks have recently become popular as candidates to be a part of multimodal analgesia, especially for patients who require limited use of drugs in multimodal analgesia (such as liver failure, renal failure, platelet dysfunction, and peptic ulcer) or those with hypersensitivity to any of these drugs. As there are potential advantages such as a longer distance between the needle and neurovascular structures, less motor blockade and less hemodynamic change, fascial plane blocks can provide effective solutions to many difficulties faced by anesthesiologists in the perioperative period. Transversus Abdominis Plane block has emerged as an effective method to minimize postoperative pain in adult patients undergoing abdominal surgery. Several randomized trials in children undergoing laparoscopic appendicectomy, minimally invasive cholecystectomy, and other laparoscopic abdominal procedures have demonstrated that ultrasound-guided Transversus Abdominis Plane block reduces pain scores, opioid consumption, and even pulmonary complications such as atelectasis when compared with port site infiltration or systemic analgesia alone.
External oblique intercostal block is a novel block, which has been described as an important modification of the fascial plane blocks that can consistently involve the upper lateral abdominal walls. External oblique intercostal block block targets the external oblique intercostal plane, allowing for effective analgesia across the upper abdominal wall, including both median and lateral regions. This contrasts with the Transversus Abdominis Plane block block, which may not adequately cover the lateral cutaneous intercostal branches, limiting its effectiveness in certain surgical procedures. Many previous studies that have concentrated on the use of different TAP block strategies, including subcostal Transversus Abdominis Plane block; have shown that it could not sufficiently block the lateral cutaneous intercostal branches.
The aim of study is to compare the efficacy of the External Oblique Intercostal plane block with the Transversus Abdominis Plane block in acute postoperative pain control in pediatric patients undergoing laparoscopic Splenectomy.
- Primary outcome: Postoperative Numerical rating scale score.
Secondary outcomes
- The amount of morphine consumption postoperatively.
- Time to first opioid request .
- Intraoperative fentanyl consumption.
- Intraoperative vital signs including mean arterial pressure and heart rate.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tanta, Egypt
- Tanta University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children of both gender,
- aged 8 to 16 years with American Society of Anesthesiologists Physical Status I to III,
- who were scheduled for laparoscopic Splenectomy surgery.
Exclusion Criteria:
- Parents declined to participate in the trial.
- Physical or developmental delay.
- Pre-existing renal or cardiovascular disease, bone disease, or gastrointestinal disorders.
- Infection at proposed injection sites.
- Prior major abdominal surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EOI group (Group E)
30 patients will receive ultrasound-guided left EOI block
|
patients will receive ultrasound-guided left EOI block.
|
|
Experimental: TAP group (Group T)
30 patients will receive ultrasound-guided left TAP block
|
patients will receive ultrasound-guided left TAP block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numerical rating scale score
Time Frame: Numerical rating scale score will be assessed postoperatively 10, 30 and 60 minutes then 2 , 4 , 6 , 12 , 24 hours postoperatively
|
Numerical rating scale score
|
Numerical rating scale score will be assessed postoperatively 10, 30 and 60 minutes then 2 , 4 , 6 , 12 , 24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative Heart rate values
Time Frame: every 15 minutes until end of surgery
|
Intraoperative Heart rate values at the time of port placement and every 15 min until end of surgery
|
every 15 minutes until end of 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
Keywords
Other Study ID Numbers
- 36264PR131092/11/25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
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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