Combined Ultrasound Guided Bilateral Rectus Sheath and Erector Spinae Plain Blocks Versus Erector Spinae Plain Block for Intra and Postoperative Analgesia in Elective Abdominoplastic Surgeries. a Randomized Controlled Double Blinded Trial.
January 3, 2025 updated by: Hassan Mohamed Ali, Cairo University
The goal of this clinical trail is to determine if bilateral erector spinae plane block alone can provide good perioperative analgesia for abdominoplastic surgery patients or it is better to give combined bilateral rectus sheath and erector spinae plane blocks to achieve effective intraoperative and postoperative analgesia with minimal morphine consumption in such operations in which there is an extensive surgical dissection and a high risk of respiratory problems.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This study is randomized controlled trail in which 40 adult patients (male or female) scheduled for elective abdominoplastic surgeries during the study duration will be randomized into to equal groups to investigate the efficacy of erector spinae plane block alone versus the efficacy of combine use of erector spinae and rectus sheath plane block for intra and postoperative analgesia in abdominoplastic surgery patients.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: yahya Mohamed Hammad, MD
- Phone Number: 00201114048081
- Email: yahya196cm@hotmail.com
Study Locations
-
-
-
Cairo, Egypt, 4240310
- Recruiting
- Cairo University Hospital
-
Contact:
- AHMED ABDALWAHAB, MD
- Phone Number: 00201221467688
- Email: dr.ahmedabdalwahab@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- patients Age from 21 to 60 years ,Male and female patients ,ASA I, II patients scheduled for elective abdominoplastic surgeries during the study duration.
Exclusion Criteria:
- Patient refusal, Age less than 21 and above 60 years old, ASA III, IV patients., Infection at the site of injection, Opioid addiction, Allergy to any used substances (lidocaine, bupivacaine)., Preexisting severe or uncontrolled respiratory, renal or cardiac disease. , INR more than 1.5 and platelets less than 100000.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group A
20 Adult patients scheduled for elective abdominoplastic surgeries under general anethesia
|
the patient will recieve ultrasound guided erector spinae plane blockbe.
A 20-gauge needle will be placed between the erector spinae muscle and the thoracic transverse processes at the level of T10 using an 'in plane' technique, 20 ml of (0.25% bupivacaine and 1% xylocaine) will be injected on each side.
the patient will recieve ultrasound guided rectus sheath block.
An 18-gauge needle will be introduced- in plane- just below the costal margin at an angle of approximately 45 degrees to the skin between the rectus abdominis muscle and posterior rectus sheath.
10 ml of (0.25% bupivacaine and 1% xylocaine) will be injected on each side.
|
|
Active Comparator: Group B
20 Adult patients scheduled for elective abdominoplastic surgeries under general anethesia
|
the patient will recieve ultrasound guided erector spinae plane blockbe.
A 20-gauge needle will be placed between the erector spinae muscle and the thoracic transverse processes at the level of T10 using an 'in plane' technique, 20 ml of (0.25% bupivacaine and 1% xylocaine) will be injected on each side.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary outcome
Time Frame: one hour
|
Visual Analogue Scale (VAS) measures pain intenesity one hour after extubation
|
one hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Secondary Outcome
Time Frame: first 24 hours postoperative
|
Total morphine consumption during 1st 24 hours postoperatively
|
first 24 hours postoperative
|
|
Secondary Outcome
Time Frame: During opration
|
Total intraoperative fentanyl consumption.
|
During opration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hassan Mohamed Ali, Phd, Professor of anesthesia Cairo university faculty of medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2024
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
December 28, 2024
First Submitted That Met QC Criteria
January 3, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 3, 2025
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS-370-2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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