- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07395661
Comparison Of Analgesic Methods İn Video-Assisted Thoracoscopic Surgery
Comparıson Of The Postoperatıve Analgesıc Effıcacy Of Serratus Anterıor Plane Block And Serratus Posterıor Superıor Intercostal Plane Block Performed Under Ultrasonography Guıdance In Vıdeo-Assısted Thoracoscopıc Surgery
Comparison of the Analgesic Efficacy of Serratus Anterior Plane Block and Serratus Posterior Superior Intercostal Plane Block in Patients Undergoing Video-Assisted Thoracoscopic Surgery Introduction and Objective: The aim of this study is to compare the postoperative analgesic efficacy of the serratus anterior plane block and serratus posterior superior intercostal plane block performed under ultrasonography guidance in patients undergoing video-assisted thoracoscopic surgery.
Patients with ASA grades I-III, aged 18-65, will be included in the study. Standard general anesthesia will be administered to the patients. Postoperative analgesia evaluation will be conducted using VAS and NRS scores at specific time points after surgery Additional analgesic requirements and patient satisfaction will be recorded.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kayapınar
-
Diyarbakır, Kayapınar, Turkey (Türkiye), 21100
- University of Health Siences Gazi Yasargil Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient aged between 18 and 65 years ASA physical status I-III Scheduled for elective video-assisted thoracoscopic surgery (VATS) Provided written information consent
Exclusion Criteria:
- History of allergy or toxicity to local anesthetic agents
- Known or suspected coagulopathy
- Infection at the site of block injection
- Advanced organ failure
- Diagnosed mental retardation
- Pregnancy
- Pediatric patients
- History of thoracotomy
- Requirement for postoperative intubation
- Emergency surgery
- Refusal to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SERRATUS ANTERİOR PLANE BLOCK
Participants received an ultrasound-guieded serratus anterior plane block (SAPB)
|
Ultrasound-guided serratus anterior plane block was performed at the 4th intercostal level in the mid-axillary line using an in plane technique.
A total of 30 ml of %0.25 bupivacaine was injected into the fascial plane between the latissumus dorsi and serratus anterior muscles (unilateral)
Other Names:
|
|
Experimental: SERRATUS POSTERİOR SUPERİOR İNTERCOSTAL PLANE BLOCK
Participants received an ultrasound-guided serratus posterior superior intercostal plane block (SPSIPB)
|
Ultrasound-guided serratus posterior superior intercostal plane block was performed using an in plane technique.
A total of 30 ml of %0.25 bupivacaine was injected into the fascial plane between the serratus posterior superior and intercostal muscles at the 3rd rib level via a posterior approach (unilateral)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain intensity
Time Frame: At postoperative 30 minute and 1, 4, 8, 12, 24 hours
|
Postoperative pain intensity was assessed using the Visual Analog Scale (VAS) where 0 indicates no pain and 10 indicates the worst imaginable pain
|
At postoperative 30 minute and 1, 4, 8, 12, 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain intensity assessed by Numeric Rating Scale (NRS)
Time Frame: 30 minutes, 1, 4, 8, 12, 24 hours after surgery
|
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain imaginable)
|
30 minutes, 1, 4, 8, 12, 24 hours after surgery
|
|
Total 24-hour tramadol consumption
Time Frame: 24 hours after surgery
|
Total amount of rescue tramadol administered within the first 24 postoperative hours, recorded in milligrams
|
24 hours after surgery
|
|
Rescue analgesia requirement
Time Frame: At postoperative 30 minute and 1, 4, 8, 12, 24 hours
|
Proportion of patients requiring rescue analgesia (intravenous tramadol) at each postoperative assessment time point
|
At postoperative 30 minute and 1, 4, 8, 12, 24 hours
|
|
Adverse events
Time Frame: Within 24 hours after surgery
|
Incidence of local anesthetic systemic toxicity, pneumothorax, hypotension, nausea/vomiting, and block-related complications
|
Within 24 hours after surgery
|
|
Dynamic (movement-associated) postoperative pain intensity
Time Frame: At postoperative 30 minute and 1, 4, 8, 12, 24 hours
|
Postoperative pain intensity during movement/coughing was assessed using the Visual Analog Scale (VAS), distinct from the primary outcome which assessed pain at rest (static VAS)
|
At postoperative 30 minute and 1, 4, 8, 12, 24 hours
|
Collaborators and Investigators
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 225
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
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