- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05852561
Comparison of Superficial+Deep Vs. Deep Serratus Anterior Plan Block in Video-Assisted Thoracic Surgery
Comparison of Combined Superficial and Deep Serratus Anterior Plan Block Versus Deep Serratus Anterior Plan Block for Postoperative Pain Control in Video-Assisted Thoracic Surgery
Thoracotomy is one of the most painful surgeries; Video-assisted thoracoscopic surgery (VATS) has been developed to reduce the surgical stress of thoracotomy. However, patients may experience moderate to severe pain within the first 24 hours after VATS. Intravenous opioids are frequently used to provide postoperative analgesia, and accordingly, side effects such as postoperative nausea/vomiting and respiratory depression can be seen.
The aim of this study is to compare Superficial+Deep Vs. Deep Serratus Anterior Plan Block for postoperative pain control in VATS cases.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Erzurum, Turkey, 25100
- Ali Ahiskalioglu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- American Society of Anesthesiologist's physiologic state I-III patients
- To undergo Video Assisted Thoracic Surgery
- Being between the ages of 18-65 years
Exclusion Criteria:
- having a known heart, kidney, liver or hematological disease
- having a history of peptic ulcer, gastrointestinal bleeding, allergy, chronic pain
- Routine analgesic use and history of analgesic use in the last 24 hours
- Not willingto participate in the study
- Uncooperative patients who have coagulopathy or use anticoagulant drugs
- To be allergic to one of the drugs to be used
- Contraindication for Video Assisted Thoracic Surgery
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 |
|---|---|
|
Active Comparator: Group Superficial+Deep Serratus Anterior Plan Block
Superficial+Deep Serratus Anterior Plan Block after Video-Assisted Thoracic Surgery
|
The block will be performed after induction of general anesthesia and surgical positioning.
15 ml of 0.375% Bupivacaine + epinephrine 5 µg/ml will be administered between the serratus anterior and latissimus dorsalis muscles.
The same concentration of block fluid will be applied between the serratus anterior and the outer intercostal muscle.
|
|
Active Comparator: Group Deep Serratus Anterior Plan Block
Deep Serratus Anterior Plan Block after Video-Assisted Thoracic Surgery
|
30 ml 0.375% Bupivacaine + epinephrine 5 µg/ml will be administered between the serratus anterior and outer intercostal muscle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative opioid consumption
Time Frame: first 24 hours
|
First 24 hours total fentanyl consumption with patient controlled analgesia
|
first 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analog pain score
Time Frame: first 48 hours
|
Post operative pain will be evaluated with a Visual Analogue Scale (between 0-10; 0: no pain, 10:worst pain) score
|
first 48 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Elif Oral Ahiskalioglu, Atatürk University
Publications and helpful links
General Publications
- Lee J, Kim S. The effects of ultrasound-guided serratus plane block, in combination with general anesthesia, on intraoperative opioid consumption, emergence time, and hemodynamic stability during video-assisted thoracoscopic lobectomy: A randomized prospective study. Medicine (Baltimore). 2019 May;98(18):e15385. doi: 10.1097/MD.0000000000015385.
- Qiu L, Bu X, Shen J, Li M, Yang L, Xu Q, Chen Y, Yang J. Observation of the analgesic effect of superficial or deep anterior serratus plane block on patients undergoing thoracoscopic lobectomy. Medicine (Baltimore). 2021 Jan 22;100(3):e24352. doi: 10.1097/MD.0000000000024352.
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
Other Study ID Numbers
- ataunivatsanalgesia
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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