- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07666334
Subtransverse Process Interligamentary Plane Block Versus Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block for Analgesia in Pediatric Thoracotomy
Ultrasound- Guided Subtransverse Process Interligamentary Plane Block Versus Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block for Analgesia in Pediatric Thoracotomy: A Randomized Controlled Study
Study Overview
Status
Conditions
Detailed Description
Post-thoracotomy pain is one of the most severe types of pain on the first day of the surgery. In pediatric patients, inadequate analgesia may lead to adverse circulatory and respiratory compromise.
The subtransverse process interligamentary (STIL) plane block is a recently introduced technique that offers a safer alternative by targeting thoracic nerves without entering the paravertebral space.
Recently, some studies have shown that the rhomboid intercostal block (RIB) and the RIB combined with the sub-serratus plane block (RISS) can provide good analgesia effects after video assisted thoracoscope.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Walaa A Elbialy, MSc
- Phone Number: 00201095519412
- Email: walaaelbialy156@gmail.com
Study Locations
-
-
El-Gharbia
-
Tanta, El-Gharbia, Egypt, 31527
- Recruiting
- Tanta University
-
Sub-Investigator:
- Mohammed S Elsharkawy, MD
-
Sub-Investigator:
- Naglaa K Mohamed, MD
-
Contact:
- Walaa A Elbialy, MSc
- Phone Number: 00201095519412
- Email: walaaelbialy156@gmail.com
-
Sub-Investigator:
- Lobna M AboAlnassr, MD
-
Sub-Investigator:
- Mohamed A Lotfy, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pediatric patients between 6 to 12 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) Physical Status I - II.
- Scheduled for thoracic surgery with thoracotomy incision under general anesthesia.
Exclusion Criteria:
- Parents who refused regional anesthesia.
- Patients were presented with advanced kidney, cardiac or liver diseases.
- Coagulation and bleeding disorders.
- Patients presented with skin or soft tissue infection at the proposed site of needle Insertion.
- Patients with cognitive impairment.
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 |
|---|---|
|
Active Comparator: Control Group
Patients will receive no block intervention and standard intravenous analgesia will be given.
|
Patients will receive no block intervention and standard intravenous analgesia will be given.
|
|
Experimental: STIL block
Patients will receive ipsilateral ultrasound-guided subtransverse process interligamentary (STIL) plane block with bupivacaine 0.25% (0.5 mL/kg) after induction of general anesthesia.
|
Patients will receive ipsilateral ultrasound-guided subtransverse process interligamentary (STIL) plane block with bupivacaine 0.25% (0.5 mL/kg) after induction of general anesthesia.
|
|
Experimental: RISS block group
Patients will receive ipsilateral ultrasound-guided rhomboid intercostal block (RIB) combined with sub-serratus plan block group with bupivacaine 0.25% (0.5mL/kg) after induction of general anesthesia.
|
Patients will receive ipsilateral ultrasound-guided rhomboid intercostal block (RIB) combined with sub-serratus plan block group with bupivacaine 0.25% (0.5mL/kg) after induction of general anesthesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to first rescue analgesia
Time Frame: 24 hours postoperatively
|
Time to the first rescue analgesia will be recorded from the end of surgery till first dose of morphine adminstrated.
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of pain
Time Frame: 24 hours postoperatively
|
Each patient will be instructed about postoperative pain assessment with VAS.
VAS (0 represents "no pain" while 10 represents "the worst pain imaginable").
VAS will be assessed after surgery over 24 hours (30 minutes postoperative, 2, 4, 6, 12, 24 hours.
|
24 hours postoperatively
|
|
Total Opioids consumption
Time Frame: 24 hours postoperatively
|
Morphine 0.05 mg /kg IV will be given as rescue analgesia if VAS score ≥4, morphine dose will not exceed 0.3 mg/kg/day.
|
24 hours postoperatively
|
|
Intraoperative fentanyl consumption
Time Frame: Intraoperatively
|
Fentanyl 0.5 μg/kg will be administrated in the case of inadequate analgesia that defined as an un explained increase of heart rate (HR) and/or mean arterial blood pressure (MAP) more than 20% above the preoperative values after exclusion of other causes.
|
Intraoperatively
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 36265MD454/8/25
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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