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Clinical Trials/NCT07436806
NCT07436806
Recruiting
Not Applicable

Evaluation of Serratus Posterior Superior (SPS) Block Versus Surgical Intercostal Blockade in Preventing Chronic Post-Thoracotomy Pain After Video-Assisted Thoracoscopic Surgery (VATS): A Randomized, Prospective, Comparative Study.

Medipol University1 site in 1 country40 target enrollmentStarted: March 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Medipol University
Enrollment
40
Locations
1
Primary Endpoint
Incidence and severity of Chronic Post-Thoracotomy Pain (CPTP)

Overview

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).

Detailed Description

Although VATS is a minimally invasive technique, chronic post-thoracotomy pain (CPTP) remains a significant complication due to intercostal nerve injury. This study investigates whether the preemptive analgesic effect of the SPS block, performed under ultrasound guidance before surgery, reduces the incidence and severity of chronic pain more effectively than standard surgical intercostal blocks. Secondary objectives include assessing acute pain scores (VAS/NRS) within the first 24 hours, total opioid consumption, and duration of hospital stay.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

The patients will be blind to the study groups.

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Arms & Interventions

SPS Block Group

Experimental

SPS Block will be performed at the end of the surgery

Intervention: SPS block (Drug)

Surgical Intercostal Blockade Group

Active Comparator

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

Intervention: Surgical Intercostal Blockade. (Drug)

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

  • 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.)

Investigators

Sponsor
Medipol University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bahadir Ciftci

Principal Investigator

Medipol University

Study Sites (1)

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