NCT07238348

Brief Summary

This prospective observational study aims to compare the postoperative analgesic effectiveness of three commonly used pain management strategies in video-assisted thoracoscopic surgery (VATS): Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Thoracic Epidural Analgesia (TEA), and systemic opioid analgesia. The study evaluates postoperative pain scores, opioid consumption, and the need for rescue analgesics within the first 24 hours after surgery. By analyzing analgesic performance and safety profiles of these techniques, the study seeks to provide evidence to guide optimal postoperative pain management for patients undergoing minimally invasive thoracic procedures.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Dec 2025

Shorter than P25 for all trials

Status
not yet 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 Progress75%
Dec 2025Aug 2026

First Submitted

Initial submission to the registry

November 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
25 days until next milestone

Study Start

First participant enrolled

December 15, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Expected
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

November 14, 2025

Last Update Submit

November 18, 2025

Conditions

Keywords

Serratus Posterior Superior Intercostal Plane BlockThoracic Epidural AnalgesiaSystemic Opioid AnalgesiaVideo-Assisted Thoracoscopic SurgeryOpioid ConsumptionPain Management

Outcome Measures

Primary Outcomes (1)

  • Opioid Consumption

    Total Opioid Consumption at 24 Hours

    24 hours postoperatively

Secondary Outcomes (8)

  • Pain Scores

    0, 1, 2, 6, 12, and 24 hours after surgery

  • Need for Rescue Analgesia

    First 24 hours postoperatively

  • Incidence of Postoperative Nausea and Vomiting (PONV)

    First 24 hours postoperatively

  • Heart Rate (beats per minute)

    Intraoperative and first 24 hours postoperative

  • Quality of Recovery Score (QoR-15)

    Preoperative baseline and 24 hours postoperative

  • +3 more secondary outcomes

Study Arms (3)

SPSIPB Group

Patients receiving Serratus Posterior Superior Intercostal Plane Block (SPSIPB) as part of routine postoperative analgesia for VATS.

Thoracic Epidural Analgesia (TEA) Group

Patients receiving thoracic epidural analgesia with continuous epidural infusion for postoperative pain control following VATS.

Systemic Opioid Analgesia Group

Patients managed with intravenous systemic opioid analgesia (e.g., tramadol PCA) as standard postoperative analgesia after VATS.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (18-75 years) undergoing elective video-assisted thoracoscopic surgery (VATS) under general anesthesia at a tertiary university hospital. Patients will receive SPSIPB, thoracic epidural analgesia, or systemic opioid analgesia as part of routine clinical practice, and will be followed for postoperative pain outcomes within the first 24 hours.

You may qualify if:

  • Adults aged 18-75 years
  • Scheduled for elective video-assisted thoracoscopic surgery (VATS)
  • ASA physical status I-III
  • Ability to understand study procedures and provide written informed consent
  • Hemodynamically stable preoperatively

You may not qualify if:

  • Known allergy or contraindication to local anesthetics or study medications
  • Coagulopathy or use of anticoagulants not suitable for regional anesthesia
  • Local infection or skin lesions at the injection site
  • Severe pulmonary disease (e.g., severe COPD, uncontrolled asthma)
  • Chronic opioid use or chronic pain disorders
  • Neurological or psychiatric disorders impairing cooperation
  • Pregnancy or breastfeeding
  • BMI \> 35 kg/m²
  • Conversion from VATS to thoracotomy
  • Inability to comply with postoperative assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Bilal B, Ciftci B, Alver S, Ahiskalioglu A, Tulgar S. Serratus posterior superior intercostal plane block: novel block for minimal invasive cardiac surgery -A report of three cases. Korean J Anesthesiol. 2024 Feb;77(1):166-168. doi: 10.4097/kja.23542. Epub 2023 Oct 18. No abstract available.

    PMID: 37852626BACKGROUND
  • 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: 36883093BACKGROUND
  • Koksal BG, Baytar C, Bayraktar E, Balbaloglu H. Effects of serratus posterior superior intercostal plane block on postoperative analgesia in patients undergoing breast cancer surgery: a randomized controlled trial. BMC Anesthesiol. 2025 Apr 24;25(1):209. doi: 10.1186/s12871-025-03092-0.

    PMID: 40275145BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Dr

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 20, 2025

Study Start

December 15, 2025

Primary Completion

May 15, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the study does not include a data-sharing plan and contains identifiable clinical information that cannot be released.