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Clinical Trials in Italy / NCT07250373
Active, not recruiting Not applicable

Serratus Posterior Superior Intercostal Plane (SPSIP) Block Versus Intercostal Nerve (ICN) Block in Patients Undergoing Uniportal-VATS.

NCT07250373 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Not applicable
Started
2025-08-01
Last updated
2025-11-26

Condition(s) studied

Uniportal-VATSLung Resection ProceduresLocoregional AnesthesiaPost-operative Pain ManagementSerratus Posterior Superior Intercostal Plane BlockIntercostal Nerve BlockUniportal Video Assisted Thoracic Surgery

Investigational drug(s) / intervention(s)

SPSIP blockICN block

SPSIP block: While the patient is in the lateral decubitus position, a high-frequency linear transducer is placed transversely at the level of the scapular spine, visualizing the upper medial border of the scapula, trapezius muscle, rhomboid major, serratus posterior superior muscle, and the second and third ribs. Next, the transducer is rotated to obtain an oblique view, including the upper medial border of the scapula. The needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs to reach the fascial plane between the serratus posterior superior muscle and intercostal muscles using the in-plane technique. Once the needle contacts the rib, 30 mL of local anesthetic is administered superficially to the intercostal muscle.

ICN block: The ICN block will be performed by the surgeon under direct vision at the end of surgery, immediately after skin closure, by injecting 4-5 ml of local anesthetic into the intercostal spaces from levels III-IV to VII-VIII.

Study summary

This study aims to assess the effectiveness of the Serratus Posterior Superior Intercostal Plane (SPSIP) block compared to the Intercostal Nerve (ICN) block for postoperative pain control, reduction of opioid analgesic consumption, minimization of postoperative respiratory complications, and enhancement of patient satisfaction (measured using the QoR-15 index) in patients undergoing Uniportal Video-Assisted Thoracic Surgery (Uniportal VATS).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients over 18 years of age with lung neoplasm who are candidates for pulmonary resection surgery via Uniportal-VATS * Patients who have provided informed consent to participate in the study Exclusion Criteria: * Patients who refuse to participate in the study by not signing the informed consent; * Patients with severe obesity (BMI \> 35), history of OSAS with or without CPAP; * Patients classified as ASA \> 3, according to the system established by the American Society of Anesthesiologists; * Patients unable to understand the use of the NPR Scale or the PCA device that will be used for postoperative analgesia; * Patients with allergies to analgesic and/or anesthetic drugs; * Patients undergoing anticoagulant therapy; * Patients with a history of chronic pain; * Patients with an infection at the site where SPSIPB or ICNB will be performed; * Patients with a history of thoracic surgery and/or thoracic trauma with rib fractures on the side of surgery; * Patients with chest wall deformities and/or neuromuscular diseases that interfere with normal ventilatory function. Additionally, patients whose surgical procedure is intraoperatively converted to an open pulmonary resection will be excluded post hoc from the study.

Primary outcome measure(s)

  • Postoperative pain intensity — - immediately after the end of surgery; - 2 hours after the end of surgery; - 6 hours after the end of surgery; - 12 hours after the end of surgery; - 24 hours after the end of surgery.
    The measurement of postoperative pain intensity, assessed using the Numeric Pain Rating Scale (NPRS), a numerical scale that can range from 0 to 10 (where 0 means no pain and 10 corresponds to the worst imaginable pain), in the two study groups.

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Lazio

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07250373 on ClinicalTrials.gov ↗ ← All trials in Italy