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Recruiting NCT07655336

SPSIP Versus RISS Block in Volume-Preserving VATS

No phase Interventional Postoperative Pain Thoracic Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Serratus posterior superior intercostal plane block, Rhomboid Intercostal and Subserratus Block.
Who it may be relevant to
Registry conditions: Postoperative Pain, Thoracic Surgery. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Procedure Serratus posterior superior intercostal plane block
    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.
  • Procedure Rhomboid Intercostal and Subserratus Block
    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.

Primary outcome measures

  • Incidence of Somatic Pain at Chest Tube Insertion Site [Time frame: Postoperative 2 hours]
Secondary outcome measures (7)
  • Postoperative Pain Scores at Rest [Time frame: Postoperative 2, 6, 12, and 24 hours]
  • Postoperative Pain Scores During Movement [Time frame: Postoperative 2, 6, 12, and 24 hours]
  • Total Intravenous Morphine Consumption [Time frame: Postoperative 24 hours]
  • Interval Intravenous Morphine Consumption [Time frame: Postoperative 0-8, 8-16, and 16-24 hours]
  • Right Hemidiaphragm Excursion [Time frame: Preoperative and postoperative 6 hours]
  • Peak Expiratory Flow [Time frame: Preoperative and postoperative 6 hours]
  • Quality of Recovery-15 Score [Time frame: Postoperative 24 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Bursa City Hospital — Bursa

Identifiers

NCT: NCT07655336 · 26-AKD-150 · 2025-KAEK-47

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗