- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06452225
Transversus Abdominis Plane Block Versus External Oblique Intercostal Plane Block for Postoperative Analgesia in Pediatrics Undergoing Open Nephrectomy
Ultrasound Guided Transversus Abdominis Plane Block Versus External Oblique Intercostal Plane Block for Postoperative Analgesia in Pediatrics Undergoing Open Nephrectomy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Nephrectomy in children may also be for malignant conditions of the kidney and adrenal glands. The major indications for nephrectomy vary in different parts of the world and in different age groups and sexes with some recording more benign conditions and others more of malignancies Ultrasound-guided transversus abdominis plane (TAP) block is a relatively new technique to infiltrate regional anesthesia in which local routine anesthetics are injected between the internal oblique and transverse abdominal muscles. The purpose is to provide analgesia to the parietal peritoneum as well as the skin and muscles of the anterior abdominal wall.
External oblique intercostal plane block (EOIPB) has been reported by Elsharkawy et al. in 2021 as a significant modification of fascial plane blocks in that it may engage the upper lateral abdominal walls consistently. In comparison to quadratus lumborum block (QLB) and erector spinae plane block (ESPB) , The advantage of EOIPB is that it may be performed with the patient supine. Furthermore, in comparison to serratus intercostal plane block (SIPB), it generates more extensive analgesic effects throughout the whole midline of the abdomen .
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
El-Gharbia
-
Tanta, El-Gharbia, Egypt, 31527
- Tanta University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≤ 18 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-III.
- Scheduled for open nephrectomy.
Exclusion Criteria:
- Abnormal blood coagulation.
- Scar, infection, and tumor of puncture site.
- History or family history of high malignant fever.
- Severe cardiovascular problems.
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: Transversus Abdominis Plane Block
Patients will receive ultrasound guided transversus abdominis plane block.
|
Patients will receive ultrasound guided transversus abdominis plane block.
|
|
Experimental: External Oblique Intercostal Plane Block
Patients will receive external oblique intercostal plane block.
|
Patients will receive external oblique intercostal plane block.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to the 1st rescue analgesia
Time Frame: 24 hours postoperatively
|
A standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 15 mg /kg/8 hrs as routine analgesia. Rescue analgesia of morphine will be given as 0.05 mg/kg if face, legs, activity, and cry consolability scale (FLACC) ≥ 4 and the maximum allowed dose is 0.1mg/kg every 4 hours. FLACC will be assessed at 0, 2, 4, 8, 12 and 24h postoperatively. it will be measured from the end of surgery to first dose of morphine administrated. |
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative fentanyl consumption
Time Frame: Intraoperatively
|
Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).
|
Intraoperatively
|
|
Total morphine consumption
Time Frame: 24 hours postoperatively
|
Rescue analgesia of morphine will be given as 0.05 mg/kg if the face, legs, activity, and cry consolability scale (FLACC) ≥ 4 and the maximum allowed dose is 0.1mg/kg every 4 hours.
|
24 hours postoperatively
|
|
Degree of pain
Time Frame: 24 hours postoperatively
|
The pain will be assessed by using the face, legs, activity, and cry consolability scale (FLACC). The level of response for each observation is given a numerical value rating from "0" to "2," with "0" being the most comfortable with no pain and "2" being the most painful , which results in a total score between "0" and "10". It will be assessed at 0, 2, 4, 8, 12 and 24h postoperatively. |
24 hours postoperatively
|
|
Mean arterial pressure
Time Frame: Every 15 minutes till the end of surgery
|
Mean arterial pressure will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.
|
Every 15 minutes till the end of surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate
Time Frame: Every 15 minutes till the end of surgery
|
Heart rate will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.
|
Every 15 minutes till the end of surgery
|
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
- 36264PR641/4/24
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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