- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07655336
SPSIP Versus RISS Block in Volume-Preserving VATS (SRVATS)
Comparison of Serratus Posterior Superior Intercostal Plane Block and Rhomboid Intercostal-Subserratus Plane Block on Postoperative Analgesia and Respiratory Functions in Volume-Preserving Video-Assisted Thoracoscopic Surgery: A Prospective Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Video-assisted thoracoscopic surgery (VATS) is associated with significant postoperative pain that may impair respiratory function and delay recovery. Regional anesthesia techniques are increasingly used to improve analgesia while minimizing opioid-related adverse effects.
The Serratus Posterior Superior Intercostal Plane (SPSIP) block and the Rhomboid Intercostal and Subserratus (RISS) block are novel ultrasound-guided fascial plane blocks that provide thoracic analgesia through different mechanisms. However, comparative clinical evidence regarding their efficacy in VATS patients remains limited.
This prospective, randomized, controlled study will enroll 84 adult patients scheduled for volume-preserving VATS. Participants will be randomly assigned to receive either SPSIP block or RISS block in a 1:1 ratio (42 patients per group).
The primary endpoint is the incidence of somatic pain at the chest drain insertion site at postoperative 2 hours.
Secondary endpoints include postoperative pain scores at rest and during movement, total intravenous morphine consumption during the first 24 postoperative hours, Quality of Recovery-15 (QoR-15) score at postoperative 24 hours, diaphragmatic excursion measured by ultrasonography, peak expiratory flow measurements, rescue analgesic requirements, time to first rescue analgesia, incidence of postoperative nausea and vomiting, and block-related complications.
The study has been approved by the Bursa Sehir Hospital Clinical Research Ethics Committee and will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice principles.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yusuf Alan
- Phone Number: +905396210977
- Email: dryusufalan@gmail.com
Study Locations
-
-
Nilüfer
-
Bursa, Nilüfer, Turkey (Türkiye), 16100
- Bursa City Hospital
-
Contact:
- Yusuf Alan, MD
- Phone Number: 05396210977
- Email: dryusufalan@gmail.com
-
Principal Investigator:
- Yusuf Alan, MD
-
Sub-Investigator:
- Onur Gunes, MD
-
Sub-Investigator:
- Halil ERTEK, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients scheduled for elective biportal video-assisted thoracoscopic surgery (VATS) with lung parenchyma-preserving thoracic procedures under general anesthesia
- American Society of Anesthesiologists (ASA) physical status I-III
- Age between 18 and 75 years
- Provision of written informed consent
Exclusion Criteria:
- Use of anticoagulant or antiplatelet therapy
- Bleeding diathesis
- Known allergy to local anesthetics
- Infection at the planned block site
- Severe chronic pulmonary disease or advanced respiratory failure (e.g., severe COPD or restrictive lung disease)
- Cognitive impairment preventing reliable NRS assessment
- Pregnancy or lactation
- Chronic opioid use (regular use for ≥3 months)
- Severe hepatic or renal failure
- Refusal to participate
- Technical failure or unsuccessful regional block
- Conversion to open thoracotomy during surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SPSIP Block Group
Patients will receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block before induction of general anesthesia for postoperative analgesia after video-assisted thoracic surgery (VATS).
|
Ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block performed before induction of general anesthesia using local anesthetic for postoperative analgesia in patients undergoing video-assisted thoracic surgery.
|
|
Experimental: RISS Block Group
Patients will receive an ultrasound-guided Rhomboid Intercostal and Subserratus (RISS) block before induction of general anesthesia for postoperative analgesia after video-assisted thoracic surgery (VATS).
|
Ultrasound-guided Rhomboid Intercostal and Subserratus (RISS) block performed before induction of general anesthesia using local anesthetic for postoperative analgesia in patients undergoing video-assisted thoracic surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Somatic Pain at Chest Tube Insertion Site
Time Frame: Postoperative 2 hours
|
Incidence of somatic pain localized at the chest tube insertion site, defined as sharp localized pain aggravated by coughing or deep inspiration, recorded as present or absent.
|
Postoperative 2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Scores at Rest
Time Frame: Postoperative 2, 6, 12, and 24 hours
|
Static postoperative pain scores assessed using the Numeric Rating Scale (NRS) at rest.
|
Postoperative 2, 6, 12, and 24 hours
|
|
Postoperative Pain Scores During Movement
Time Frame: Postoperative 2, 6, 12, and 24 hours
|
Dynamic postoperative pain scores assessed using the Numeric Rating Scale (NRS) during movement.
|
Postoperative 2, 6, 12, and 24 hours
|
|
Total Intravenous Morphine Consumption
Time Frame: Postoperative 24 hours
|
Total intravenous morphine consumption during the first 24 hours after surgery.
|
Postoperative 24 hours
|
|
Interval Intravenous Morphine Consumption
Time Frame: Postoperative 0-8, 8-16, and 16-24 hours
|
Intravenous morphine consumption recorded separately for postoperative 0-8, 8-16, and 16-24 hour intervals.
|
Postoperative 0-8, 8-16, and 16-24 hours
|
|
Right Hemidiaphragm Excursion
Time Frame: Preoperative and postoperative 6 hours
|
Right hemidiaphragm excursion measured by ultrasonography to evaluate diaphragmatic function.
|
Preoperative and postoperative 6 hours
|
|
Peak Expiratory Flow
Time Frame: Preoperative and postoperative 6 hours
|
Peak expiratory flow measured using a peak flowmeter to evaluate respiratory performance.
|
Preoperative and postoperative 6 hours
|
|
Quality of Recovery-15 Score
Time Frame: Postoperative 24 hours
|
Postoperative recovery quality assessed using the Quality of Recovery-15 (QoR-15) questionnaire.
|
Postoperative 24 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
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
- 26-AKD-150
- 2025-KAEK-47 (Other Identifier: Bursa City Hospital Clinical Research Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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