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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-KAEK-47 | Other Identifier | Bursa City Hospital Clinical Research Ethics Committee |
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| Name | Class |
|---|---|
| Bursa Sehir Hastanesi | OTHER |
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This prospective randomized controlled study aims to compare the effects of Serratus Posterior Superior Intercostal Plane (SPSIP) block and Rhomboid Intercostal and Subserratus (RISS) block on postoperative pain, respiratory function, and recovery quality in patients undergoing volume-preserving video-assisted thoracoscopic surgery (VATS). Eighty-four patients will be randomized in a 1:1 ratio to receive either SPSIP block or RISS block. The primary outcome is the incidence of somatic pain at the chest drain insertion site at postoperative 2 hours. Secondary outcomes include pain scores, opioid consumption, quality of recovery, diaphragmatic function, pulmonary function, rescue analgesic requirements, postoperative nausea and vomiting, and block-related complications.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPSIP Block Group | Experimental | 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). |
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| RISS Block Group | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serratus posterior superior intercostal plane block | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Somatic Pain at Chest Tube Insertion Site | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Scores at Rest | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yusuf Alan | Contact | +905396210977 | dryusufalan@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bursa City Hospital | Recruiting | Bursa | Nilüfer | 16100 | Turkey (Türkiye) |
Individual participant data (IPD) sharing has not yet been determined. The decision regarding data sharing will be made after study completion and in accordance with institutional policies, ethical considerations, and participant confidentiality requirements.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Prospective, randomized, double-blind, parallel-group clinical trial comparing Serratus Posterior Superior Intercostal Plane (SPSIP) block and Rhomboid Intercostal and Subserratus (RISS) block for postoperative analgesia after video-assisted thoracic surgery (VATS). Eighty-four participants will be randomized in a 1:1 ratio to receive SPSIP block or RISS block.
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Participants, outcome assessors, and investigators responsible for postoperative data collection and analysis will remain blinded to group allocation throughout the study period. Block procedures will be performed by an anesthesiologist not involved in postoperative assessments.
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| Rhomboid Intercostal and Subserratus Block | Procedure | 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. |
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Dynamic postoperative pain scores assessed using the Numeric Rating Scale (NRS) during movement.
| Postoperative 2, 6, 12, and 24 hours |
| Total Intravenous Morphine Consumption | Total intravenous morphine consumption during the first 24 hours after surgery. | Postoperative 24 hours |
| Interval Intravenous Morphine Consumption | 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 | Right hemidiaphragm excursion measured by ultrasonography to evaluate diaphragmatic function. | Preoperative and postoperative 6 hours |
| Peak Expiratory Flow | Peak expiratory flow measured using a peak flowmeter to evaluate respiratory performance. | Preoperative and postoperative 6 hours |
| Quality of Recovery-15 Score | Postoperative recovery quality assessed using the Quality of Recovery-15 (QoR-15) questionnaire. | Postoperative 24 hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |