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

NCT07250373 | Active Not Recruiting

• 1 other identifier: 7594
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Uniportal-VATS; Lung Resection Procedures; Locoregional Anesthesia; Post-operative Pain Management; Serratus Posterior Superior Intercostal Plane Block; Intercostal Nerve Block; Uniportal Video Assisted Thoracic Surgery

Keywords

SPSIP block; ICN block; Uniportal-VATS

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity

  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.

  - 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.

Secondary Outcomes (5)

• Total opioid drug consumption

  24 hours after the end of surgery.

• Consumption of rescue analgesics

  24 hours after the end of surgery.

• postoperative respiratory complications

  24 hours after the end of surgery

• postoperative quality of recovery

  24 hours after surgery

• Length of Hospital Stay

  from the end of surgery to the date of patient discharge, assessed up to 3 weeks

Study Arms (2)

SPSIP group

EXPERIMENTAL

Patients in this group will be treated with the Serratus Posterior Superior Intercostal Plane Block, administered under ultrasound guidance by the attending anesthesiologist immediately after skin closure and before extubation .

Other: SPSIP block

ICN group

ACTIVE COMPARATOR

Patients in this group will be treated with the ICN block, administered by the surgeon under direct vision at the end of surgery and immediately before skin closure.

Other: ICN block

Interventions

SPSIP block OTHER

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.

SPSIP group

ICN block OTHER

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.

ICN group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, 00135, Italy

Location

Related Publications (5)

• Avci O, Gundogdu O, Balci F, Tekcan MN, Ozbey M. Efficacy of serratus posterior superior intercostal plane block (SPSIPB) on post-operative pain and total analgesic consumption in patients undergoing video-assisted thoracoscopic surgery (VATS): A double-blinded randomised controlled trial. Indian J Anaesth. 2023 Dec;67(12):1116-1122. doi: 10.4103/ija.ija_589_23. Epub 2023 Dec 13.

  PMID: 38343684 BACKGROUND

• Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.

  PMID: 36883093 BACKGROUND

• Guerra-Londono CE, Privorotskiy A, Cozowicz C, Hicklen RS, Memtsoudis SG, Mariano ER, Cata JP. Assessment of Intercostal Nerve Block Analgesia for Thoracic Surgery: A Systematic Review and Meta-analysis. JAMA Netw Open. 2021 Nov 1;4(11):e2133394. doi: 10.1001/jamanetworkopen.2021.33394.

  PMID: 34779845 BACKGROUND

• Nachira D, Meacci E, Petracca Ciavarella L, Chiappetta M, De Santis G, Ferretti GM, Mastromarino MG, Porziella V, Vita ML, Congedo MT, Cesario A, Ismail M, Gonzalez-Rivas D, Margaritora S. Uniportal video-assisted thoracic surgery Roman experience-a report of the first 16-month Roman experience. J Thorac Dis. 2018 Nov;10(Suppl 31):S3678-S3685. doi: 10.21037/jtd.2018.03.119.

  PMID: 30505552 BACKGROUND

• Gonzalez-Rivas D, Paradela M, Fieira E, Velasco C. Single-incision video-assisted thoracoscopic lobectomy: initial results. J Thorac Cardiovasc Surg. 2012 Mar;143(3):745-7. doi: 10.1016/j.jtcvs.2011.07.049. Epub 2011 Aug 25. No abstract available.

  PMID: 21868042 BACKGROUND

Study Officials

• Giovanni Punzo, MD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

• Dania Nachira, MD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: November 26, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)