NCT07850388

Brief Summary

Thoracic surgery is frequently associated with significant postoperative pain, which may impair respiratory function, mobilization, recovery, and patient satisfaction. The Serratus Posterior Superior Intercostal Plane (SPSIP) block is a recently described ultrasound-guided fascial plane block that may provide effective analgesia after thoracic surgery. This prospective observational cohort study will evaluate the analgesic effectiveness and postoperative recovery associated with SPSIP block in adult patients undergoing elective minor video-assisted thoracoscopic surgery (VATS), major VATS, or thoracotomy. All patients will receive SPSIP block as part of routine institutional multimodal analgesia. The primary outcome will be postoperative quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours after surgery. Secondary outcomes will include postoperative pain intensity, opioid consumption, rescue analgesic requirements, postoperative nausea and vomiting, pulmonary complications, patient satisfaction, length of hospital stay, and chronic postoperative pain.

Trial Health

63
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Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Apr 2028

First Submitted

Initial submission to the registry

September 18, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 18, 2026

Last Update Submit

September 24, 2026

Conditions

Keywords

Serratus Posterior Superior Intercostal Plane BlockThoracic SurgeryRegional AnesthesiaPostoperative AnalgesiaQuality of Recovery-15

Outcome Measures

Primary Outcomes (1)

  • Quality of Recovery-15 Score at 24 Hours

    Postoperative quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15). Higher scores indicate better postoperative recovery. QoR-15 scores will be compared among the minor VATS, major VATS, and thoracotomy cohorts.

    24 hours after surgery

Secondary Outcomes (23)

  • Total Opioid Consumption During the First 24 Postoperative Hours

    0 to 24 hours after surgery

  • Pain Intensity at Rest Upon Admission to the PACU

    Upon admission to the post-anesthesia care unit (PACU)

  • Pain Intensity at Rest at 2 Hours

    2 hours after the end of surgery

  • Pain Intensity at Rest at 6 Hours

    6 hours after the end of surgery

  • Pain Intensity at Rest at 12 Hours

    12 hours after the end of surgery

  • +18 more secondary outcomes

Study Arms (3)

Minor VATS

Adult patients undergoing elective minor video-assisted thoracoscopic surgery (VATS) under general anesthesia who receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block as part of routine institutional multimodal analgesia. The surgical procedure and regional analgesic technique are determined as part of routine clinical care and are not assigned by the study protocol.

Procedure: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block

Major VATS

Adult patients undergoing elective major video-assisted thoracoscopic surgery (VATS) under general anesthesia who receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block as part of routine institutional multimodal analgesia. The surgical procedure and regional analgesic technique are determined as part of routine clinical care and are not assigned by the study protocol.

Procedure: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block

Thoracotomy

Adult patients undergoing elective thoracotomy under general anesthesia who receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block as part of routine institutional multimodal analgesia. The surgical procedure and regional analgesic technique are determined as part of routine clinical care and are not assigned by the study protocol.

Procedure: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block

Interventions

An ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed after induction of general anesthesia according to routine institutional clinical practice using a long-acting local anesthetic.

Major VATSMinor VATSThoracotomy

Eligibility Criteria

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

Adults undergoing elective minor VATS, major VATS, or thoracotomy under general anesthesia who receive SPSIP block as part of routine multimodal analgesia

You may qualify if:

  • Age 18 years or older
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective thoracic surgery
  • Undergoing minor video-assisted thoracoscopic surgery (VATS), major VATS, or thoracotomy
  • Planned ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block as part of routine multimodal analgesia
  • Able and willing to provide written informed consent

You may not qualify if:

  • Patient refusal
  • Known allergy to amide local anesthetics
  • Coagulopathy
  • Therapeutic anticoagulation incompatible with regional anesthesia
  • Infection at the planned block injection site
  • Pregnancy
  • Emergency surgery
  • Chronic opioid therapy for more than 3 months
  • Chronic pain syndrome
  • Cognitive impairment that prevents reliable study assessments
  • Inability to complete the Quality of Recovery-15 (QoR-15) questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Celebi University Atatürk Training and Research Hospital, Karabaglar, Izmir

Izmir, İzmir, 35360, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Murat Aksun, M.D.

    Izmir Katip Celebi University Atatürk Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmet Salih Tüzen, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 18, 2026

First Posted

September 30, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

No individual participant data sharing is currently planned.

Locations