Bursa City Hospital
Bursa, Nilüfer, 16100, Turkey (Türkiye)
Location status: Recruiting
Location contact
Halil ERTEK, MD
SUB_INVESTIGATOR
Onur Gunes, MD
SUB_INVESTIGATOR
Yusuf Alan, MD
CONTACT
Yusuf Alan, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07655336
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Bursa, Nilüfer, 16100, Turkey (Türkiye)
Location status: Recruiting
Halil ERTEK, MD
SUB_INVESTIGATOR
Onur Gunes, MD
SUB_INVESTIGATOR
Yusuf Alan, MD
CONTACT
Yusuf Alan, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: Postoperative 2, 6, 12, and 24 hours
Static postoperative pain scores assessed using the Numeric Rating Scale (NRS) at rest.
Time frame: Postoperative 2, 6, 12, and 24 hours
Dynamic postoperative pain scores assessed using the Numeric Rating Scale (NRS) during movement.
Time frame: Postoperative 24 hours
Total intravenous morphine consumption during the first 24 hours after surgery.
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.
Time frame: Preoperative and postoperative 6 hours
Right hemidiaphragm excursion measured by ultrasonography to evaluate diaphragmatic function.
Time frame: Preoperative and postoperative 6 hours
Peak expiratory flow measured using a peak flowmeter to evaluate respiratory performance.
Time frame: Postoperative 24 hours
Postoperative recovery quality assessed using the Quality of Recovery-15 (QoR-15) questionnaire.
Contact information is provided by the study sponsor or research team.
Ferit Yetik
Other Gov
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
Acronym: SRVATS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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