- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06653803
Rhomboid Intercostal Block Versus Retrolaminar Block for Postoperative Analgesia After Thoracoscopic Sympathectomy
Ultrasound-guided Rhomboid Intercostal Block Versus Retrolaminar Block for Postoperative Analgesia After Thoracoscopic Sympathectomy: A Randomized Clinical Trial
Background: Although thoracoscopic sympathectomy is made via small incisions, it is associated with severe postoperative pain. Both Rhomboid intercostal block (RIB) and Retrolaminar block (RLB) are recent techniques used for pain control after such procedures
Objectives: To compare the effectiveness of RIB and RLB in providing postoperative analgesia after thoracoscopic sympathectomy in adult patients and their impact on the patient's outcomes.
Patients and Methods: This prospective, randomized (1:1), double-blind clinical trial; will be carried out on 60 patients scheduled for elective thoracoscopic sympathectomy under general anesthesia at our hospital. Patients will be randomly allocated into two equal groups (30 patients each) and will receive: in group A; general anesthesia with intraoperative ipsilateral ultrasound-guided RIB, whereas in group B; general anesthesia with intraoperative ipsilateral ultrasound-guided RLB.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed M Shaat, MD
- Phone Number: 00201223482709
- Email: ahmedshaat99@gmail.com
Study Locations
-
-
El-Beheira
-
Damanhūr, El-Beheira, Egypt
- Recruiting
- Damanhour Teaching Hospital
-
Contact:
- Ahmed M Shaat, MD
- Phone Number: 00201223482709
- Email: ahmedshaat99@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Age from 18 to 60 years
- Body Mass Index (BMI) < 35 kg/m²
Exclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status > II
- Age < 18 years or > 60 years
- Body Mass Index (BMI) ≥ 35
- Local infection at the puncture site
- Altered mental status
- Pregnant women
- Allergy to study drugs
- Chronic pain
- Coagulation abnormalities or on anticoagulants
- Severe hepatic or kidney disease
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 |
|---|---|
|
Active Comparator: Group A (n=30)
Rhomboid Intercostal Block
|
Intraoperative Ipsilateral Ultrasound-guided RIB
|
|
Active Comparator: Group B (n=30)
Retrolaminar Block
|
Intraoperative Ipsilateral Ultrasound-guided RLB
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean and Standard deviation of time to the first request of postoperative rescue analgesic (minutes) (mean±SD)
Time Frame: 24 hours after the end of surgery
|
The time interval between the block performance and the first request of postoperative analgesia
|
24 hours after the end of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)
Time Frame: 24 hours after the end of surgery
|
NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (At PACU, 1h, 3h, 6h, 12h, 18h, 24h) after the end of surgery
|
24 hours after the end of surgery
|
|
Mean and Standard deviation of the total dose of the rescue analgesic consumed (milligrams) (mean±SD)
Time Frame: 24 hours after the end of surgery
|
The total dose of the rescue analgesic consumed in the first 24 hours after the end of surgery
|
24 hours after the end of surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmed M Shaat, MD, Damanhour Teaching Hospital
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
- DTH: 24001
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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