- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07360028
Efficacy of Ultrasound Guided Erector Spinae Plane Block Versus Ultrasound Guided Serratus Anterior Plane Block for Postoperative Pain Control Following Video-assisted Thoracoscopic Surgeries (VATS): Randomized Control Trial
Study Overview
Status
Conditions
Detailed Description
The aim of the study is to compare the analgesic efficacy of Erector spinae plane block versus Serratus anterior plane block in patients undergoing video-assisted thoracoscopic surgeries.
Preoperative: - On the day before surgery, all patients will be evaluated, detailed medical and surgical history will be taken also physical and systemic examinations will be done.
The following investigations will be done including complete blood count, liver enzymes, prothrombin time, partial thromboplastin time, International normalized ratio (INR) , kidney functions, serum electrolytes and ECG.
All patients will be informed about the visual analogue scale (VAS) on a scale from 0 to 10 where 0 represents no pain and 10 represents the worst imaginable pain.
In the pre-Anesthetic room:
- baseline hemodynamics will be recorded including heart rate (HR) and mean arterial blood pressure (MAP) and An intravenous access will be inserted.
- In the operating theatre, full monitors will be applied. Intraoperative: -
- Fentanyl (1 μg/kg), propofol (2 mg/kg) and atracurium(0.5 mg/kg) will be given IV for general anesthesia induction.
- Intubation will be done using a double-lumen endobronchial tube size 37 Fr in females and 39 Fr in males, tidal volume will be 6-8 ml/kg in case of both lungs ventilation and 4-6ml/kg during singe lung ventilation.
Anesthesia will continue using isoflurane 2 vol. %, 50% O2 and 50% air.
- Moreover, three milligrams of Granisetron will be given as prophylactic against nausea and vomiting post-operatively.
- During operation, 6 mL/kg/h of Ringer's solution will be administered.
- At the end of surgery, the patient will be positioned laterally.
- All blocks will be done using ultrasound-guidance (Mindray ultrasound) using high frequency linear probe (10-12 MHZ) by the same experienced senior doctors.
Group A : (25 patients) patients will receive Erector Spinae Plane Block using 20 mL of 0.25% bupivacaine.
Group B: (25 patients) patients will recieve Serratus Aneterior Plane Block using 20 mL of 0.25% bupivacaine.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: EMAN ZAGHLOUL MADY, MSc
- Phone Number: 00201013177848
- Email: Emanzaghloul@med.asu.edu.eg
Study Locations
-
-
Abbassia-Egypt
-
Cairo, Abbassia-Egypt, Egypt
- Recruiting
- Ain-Shams University Hospitals
-
Contact:
- EMAN ZAGHLOUL MADY, MSc
- Phone Number: 00201013177848
- Email: Emanzaghloul@med.asu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with American Society of Anesthesiology physical status ASA I, II and III.
- Patients aged between 25 and 70 years.
- patients undergoing video-assisted thoracoscopic surgeries (VATS), including pleurectomy, bullectomy, sympathectomy, esophagectomy, decortication, lobectomy, and pneumonectomy.
Exclusion Criteria:
- Patients below age of 25 or above age of 70.
- Patient refusal.
- Allergy to local anesthetic drugs.
- Bleeding or coagulation disorder.
- Psychiatric disorders.
- Infection at the needle entry site.
- Renal impairment (creatinine >1.5 ).
- Hepatic impairment (Child B or C).
- Patients with known Cortisol related diseases such as Cushing's Syndrome or Addison's Disease.
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: Erectror Spinae Plane Block
Ultrasound Guided block using 20 mL of 0.25% bupivacaine.
|
Ultrasound Guided Erector Spinae Plane block using 20 mL of 0.25% bupivacaine.
|
|
Active Comparator: Serratus Anterior Plane Block
Ultrasound Guided block using 20 mL of 0.25% bupivacaine.
|
Ultrasound Guided Serratus Anterior Plane Block using 20 mL of 0.25% bupivacaine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analogue scale for Assessing postoperative pain control
Time Frame: after ICU admission at 2, 4, 8, 16, 24 hours post operative.
|
Assessing The difference in postoperative pain control between both groups as determined by assessing the visual analogue scale
|
after ICU admission at 2, 4, 8, 16, 24 hours post operative.
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMASU MD 307/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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