NCT07440199

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Jan 2026Aug 2026

Study Start

First participant enrolled

January 16, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

February 6, 2026

Last Update Submit

February 23, 2026

Conditions

Keywords

NIVATSBullectomypleural biopsySerratus Posterior Superior Intercostal BlockSerratus Anterior Plan Block

Outcome Measures

Primary Outcomes (1)

  • 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.

    The amounts of remifentanyl and propofol consumed from the start to the end of the operation will also be recorded in both study groups.

Secondary Outcomes (1)

  • 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.

    Analgesic intake and NRS scores will be assessed at 1, 6, 12, 18, and 24 hours postoperatively.

Study Arms (2)

Serratus posterior superior intercostal plane block Group

ACTIVE COMPARATOR
Procedure: Serratus posterior superior intercostal plane block group

Serratus Anterior Plane Block (SAPB) group

ACTIVE COMPARATOR
Procedure: Serratus Anterior Plane Block (SAPB) group

Interventions

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.

Serratus Anterior Plane Block (SAPB) group

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.

Serratus posterior superior intercostal plane block Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fırat University Faculty of Medicine Hospital

Elâzığ, 23100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

SaposinsPopulation Groups

Intervention Hierarchy (Ancestors)

Sphingolipid Activator ProteinsCoenzymesEnzymes and CoenzymesDemographyPopulation Characteristics

Central Study Contacts

AHMET AKSU, Assistant Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 27, 2026

Study Start

January 16, 2026

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations