NCT07436806

Brief Summary

This study aims to evaluate the efficacy of ultrasound-guided Serratus Posterior Superior (SPS) block compared to surgeon-administered intercostal blockade in preventing chronic pain at 3, 6, and 12 months following Video-Assisted Thoracoscopic Surgery (VATS).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Mar 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 Progress37%
Mar 2026Dec 2026

First Submitted

Initial submission to the registry

February 13, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2026

Expected
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2026

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

February 13, 2026

Last Update Submit

March 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of Chronic Post-Thoracotomy Pain (CPTP)

    The primary aim is to compare incidence and severity of Chronic Post-Thoracotomy Pain with McGill Pain Questionnaire (MPQ).

    Incidence and severity of Chronic Post-Thoracotomy Pain (CPTP) at 3, 6, and 12 months post-surgery.

Secondary Outcomes (5)

  • Opioid consumption (Fentanyl PCA)

    Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.

  • Pain scores (Numerical rating scale-NRS)

    Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours

  • Need for rescue analgesia (meperidine)

    Postoperative 24 hours period

  • Adverse events

    Postoperative 24 hours period

  • Incidence and severity of Chronic Post-Thoracotomy Pain (CPTP)

    Incidence and severity of Chronic Post-Thoracotomy Pain (CPTP) at 3, 6, and 12 months post-surgery.

Study Arms (2)

SPS Block Group

EXPERIMENTAL

SPS Block will be performed at the end of the surgery

Drug: SPS block

Surgical Intercostal Blockade Group

ACTIVE COMPARATOR

Surgical Intercostal Blockade will be performed at the end of the surgery by the surgeon

Drug: Surgical Intercostal Blockade.

Interventions

30 mL of 0.25% Bupivacaine will be injected into the plane between the Serratus Posterior Superior muscle and the intercostal muscles at the scapular level.

SPS Block Group

At the end of the operation, the surgeon will perform an injection of a total of 30 mL of 0.25% Bupivacaine into three intercostal nerves above and below the incision site under direct thoracoscopic visualization.

Surgical Intercostal Blockade Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status I-III.
  • Scheduled for elective unilateral Video-Assisted Thoracoscopic Surgery (VATS).

You may not qualify if:

  • History of allergy to local anesthetics.
  • Pre-existing chronic pain syndrome or neuropathic pain.
  • Psychiatric disorders affecting pain assessment.
  • Coagulation disorders.
  • Previous thoracic surgery on the same side.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • Ciftci B, Alver S, Ahiskalioglu A, Bilal B, Tulgar S. Serratus posterior superior intercostal plane block: novel thoracic paraspinal block for thoracoscopic and shoulder surgery. Minerva Anestesiol. 2024 Apr;90(4):345-347. doi: 10.23736/S0375-9393.23.17827-8. Epub 2024 Jan 19. No abstract available.

    PMID: 38240640BACKGROUND
  • Dogan G, Kucuk O, Kayir S, Dal GC, Ciftci B, Zengin M, Alagoz A. Serratus posterior superior intercostal plane block versus thoracic paravertebral block for pain management after video-assisted thoracoscopic surgery: a randomized prospective study. Braz J Anesthesiol. 2025 Sep-Oct;75(5):844647. doi: 10.1016/j.bjane.2025.844647. Epub 2025 Jun 3.

    PMID: 40473018BACKGROUND
  • Cevikkalp E, Ulusoy E, Karakaya M, Ekinci M, Dikici M. Serratus posterior superior intercostal block as a component of multimodal analgesia in thoracotomy. Minerva Anestesiol. 2026 Jan 27. doi: 10.23736/S0375-9393.25.19490-X. Online ahead of print. No abstract available.

    PMID: 41591369BACKGROUND
  • Ozen V, Turan EI, Alver S, Sahin AS, Ciftci B. Combination of Fascial Plane Blocks Including Serratus Posterior Superior Intercostal Plane Block for Pediatric Thoracic Analgesia: Two Case Reports. A A Pract. 2026 Jan 14;20(1):e02144. doi: 10.1213/XAA.0000000000002144. eCollection 2026 Jan 1.

    PMID: 41533022BACKGROUND

MeSH Terms

Conditions

NeuralgiaPain, Postoperative

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Central Study Contacts

Bahadir Ciftci, Assoc Prof, MD

CONTACT

Ayse Cicek

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The patients will be blind to the study groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There are two models for this study. The first group is the SPS block. The second one is the Surgical Intercostal Blockade group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 13, 2026

First Posted

February 27, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

November 20, 2026

Study Completion (Estimated)

December 10, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

We will not plan to share IPD

Locations