- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07440199
Comparison of SPSIP Block and SAP Block in Non-Intubated Uniportal VATS.
Comparison of Serratus Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block in Uniportal Video-Assisted Thoracoscopic Surgery Without Intubation
Comparison of Serratus Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block in Uniportal Video-Assisted Thoracoscopic Surgery Without Intubation Single-port video-assisted thoracoscopic surgery without intubation (NI-UniVATS) is a technique in which video-assisted thoracoscopic surgery is performed through a single port without intubating the patient. It differs significantly from traditional VATS. The literature reports that the uniportal approach provides surgical efficiency comparable to the multiportal approach, reduces postoperative pain scores, improves patient comfort due to shorter surgery, reduced chest tube use, and reduced hospital stay, and offers superior cosmetic results.
Beyond the limited surgical trauma associated with single-port delivery, NI-UniVATS allows maintenance of physiological ventilation by preventing positive pressure on the lungs while preserving spontaneous breathing. This feature helps reduce postoperative pulmonary complications, especially in patients with impaired lung function. Avoiding intubation reduces the risk of local complications such as postoperative sore throat, mucosal ulceration, laryngeal or tracheal injuries, and bronchospasm due to mechanical irritation, while not using neuromuscular blocking agents eliminates curare-related complications.
In addition, the administration of hypnotic and opioid agents in limited doses supports faster recovery and reduces the frequency of postoperative sedation, nausea, and vomiting. Consistent with these physiological and pharmacological advantages, NIVATS stands out as an effective, patient-centered surgical approach associated with shorter hospital stays and accelerated recovery.
In the transition from aggressive surgical approaches to minimally invasive methods for treating pleural, mediastinal, and pulmonary diseases, advancements in surgical techniques and progress in anesthesia have played a decisive role. In video-assisted thoracoscopic surgery (NI-VATS), which does not require intubation, the safe performance of the procedure requires the use of appropriate anesthetic techniques to protect patients from severe hypoxia and hypercapnia, to effectively control pain during surgical resection, and to suppress the cough reflex so that the lung can be manipulated more stably and safely.
Adequate and effective analgesia is a fundamental requirement for the success of this approach. Although thoracic epidural anesthesia and paravertebral blocks provide effective analgesia, facial plane blocks such as the serratus anterior plane block, rhomboid intercostal block, and erector spinae plane block can be used alone or in combination as the primary anesthetic method in NI-VATS procedures because of their ease of application and relatively low risk of complications.
The serratus posterior superior intercostal plane block (SPSIPB), described by Tulgar et al. in 2023, has been reported to provide effective analgesia in the anterolateral hemithorax, including the C3-T10 dermatomes. Consistent with these findings, it is increasingly used for postoperative analgesia in VATS surgery. In addition, one case reports successful NI-VATS without complications after SPSIPB application. Given these features, SPSIPB has the potential to be an effective anesthetic and analgesic option in NI-VATS patients.
In light of this data, identifying an effective, safe, and easily applicable regional analgesic technique for NI-VATS procedures is clinically important. Evidence comparing the efficacy of SPSIPB, a technique recently described and gaining increasing attention in thoracic surgery, with SAPB, a facial plane block commonly used in NI-VATS procedures, is limited. The aim of this study is to evaluate the perioperative anesthetic and analgesic efficacy of ultrasound-guided SPSIPB in patients undergoing NI-VATS, compared with SAPB. The hypothesis of this study is that the serratus posterior superior intercostal plane block is non-inferior to the serratus anterior plane block in terms of intraoperative anesthetic requirements, pain control, and perioperative analgesic requirements.
Materials and Methodology Study Design and Patient Selection This study was designed as a single-center, prospective, randomized, double-blind trial. The study protocol was approved by the Ethics Committee for Clinical Research at Fırat University Faculty of Medicine (Approval No: 2023-181). After approval, a total of 70 patients scheduled to undergo elective non-intubated uniportal video-assisted thoracoscopic surgery (NI-UniVATS) were included in the study. The research was conducted between 20 January 2026 and 15 August 2026.
Inclusion Criteria
The study included patients who:
- were aged 18-65 years,
- had an American Society of Anaesthesiologists (ASA) physical status classification of I-III,
- had a body mass index (BMI) < 35 kg/m²,
- read and signed the informed consent form. Exclusion Criteria
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: AHMET AKSU, Assistant Professor
- Phone Number: +90-530-349-3896
- Email: aaksu@firat.edu.tr
Study Locations
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Elâzığ, Turkey (Türkiye), 23100
- Recruiting
- Fırat University Faculty of Medicine Hospital
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Contact:
- İsmail Demirel, Professor
- Phone Number: +90 533 466 88 66
- Email: ismaildemirel23@firat.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
The study included patients who:
- were aged 18-65 years,
- had an American Society of Anaesthesiologists (ASA) physical status classification of I-III,
- had a body mass index (BMI) < 35 kg/m²,
- read and signed the informed consent form.
Exclusion Criteria:
Patients;
- Unable to communicate in Turkish or refusing to participate in the study,
- Unable to use the numerical pain rating scale (NRS),
- History of allergy to local anaesthetics or analgesics used in the study,
- Pregnant or breastfeeding,
- History of uncontrolled anxiety disorder or substance dependence,
- Previous thoracic surgery or history of thoracic trauma,
- Widespread pleural adhesions detected during preoperative assessment,
- Neuromuscular or peripheral nervous system disease,
- Diabetes mellitus, hepatic or renal insufficiency, or coagulation disorder,
- Chronic opioid or steroid use,
- Widespread pain syndrome,
- Receiving anticoagulant therapy,
- Patients with infection detected in the area where the block will be applied were excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Serratus posterior superior intercostal plane block Group
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The anesthesiologist performing the block had more than three years of experience in ultrasound-guided regional anesthesia and applied the procedure according to the group assignment determined by sealed envelope.
In the SPSIPB group, patients were positioned in the lateral decubitus position.
After slight lateral displacement of the scapula, the scapular spine was visualized, and the probe was moved medially to identify the superior angle of the scapula and the third rib.
The block needle was advanced in a craniocaudal direction and positioned between the serratus posterior superior muscle and the third rib.
Correct placement was confirmed by hydrodissection using 2 mL saline, followed by injection of 30 mL of 0.25% bupivacaine.
Patients were monitored for 15 minutes in the procedure room, during which 5 mL of 2% lidocaine was administered via nebulization.
Sensory block was assessed with a needle prick test over T1-T7 dermatomes before transfer to the operating theatre.
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Active Comparator: Serratus Anterior Plane Block (SAPB) group
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The anesthesiologist performing the block had more than three years of experience in ultrasound-guided regional anesthesia and applied the procedure according to the group assignment determined by sealed envelope.
The patient in the SAPB group was positioned in the lateral decubitus position.
SAPB was performed under ultrasound guidance using a high-frequency linear probe (LOGIQ e, GE Healthcare).
The probe was placed parallel to the mid-axillary line, and the fifth rib was identified as a hyperechoic structure.
Using an in-plane technique, 20 mL of 0.25% ropivacaine was injected into the myofascial plane between the serratus anterior muscle and the fifth rib.
The needle was then withdrawn to the plane between the serratus anterior and latissimus dorsi muscles, and correct placement was confirmed by hydrodissection.
After negative aspiration, an additional 10 mL of 0.25% ropivacaine was administered, and the needle was removed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Comparison of the intraoperative anesthetic and analgesic efficacy of ultrasound-guided SPSIPB with SAPB in patients undergoing NI-VATS. The primary outcome was intraoperative consumption of anesthetic and analgesic agents during the surgical procedure.
Time Frame: The amounts of remifentanyl and propofol consumed from the start to the end of the operation will also be recorded in both study groups.
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The amounts of remifentanyl and propofol consumed from the start to the end of the operation will also be recorded in both study groups.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Secondary outcomes included postoperative pain intensity measured by NRS, total analgesic consumption, time to first rescue analgesia, QoR-15 recovery scores, and the incidence of block-related complications.
Time Frame: Analgesic intake and NRS scores will be assessed at 1, 6, 12, 18, and 24 hours postoperatively.
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Analgesic intake and NRS scores will be assessed at 1, 6, 12, 18, and 24 hours postoperatively.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
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
- 43756
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
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