NCT07232940

Brief Summary

Video-assisted thoracoscopic surgery (VATS) is a minimally invasive procedure performed through small thoracic incisions, but postoperative pain remains significant due to tissue and rib trauma. Poorly controlled pain may lead to chronic postoperative pain; therefore, optimal analgesia is essential. According to PROSPECT guidelines, erector spinae plane block (ESPB) or paravertebral block (PVB) are recommended for VATS. The recently defined serratus posterior superior intercostal plane block (SPSIPB) provides analgesia between C3-T10 levels, but its efficacy compared with ESPB has not been studied. This study aims to compare postoperative analgesic efficacy and patient satisfaction between ESPB and SPSIPB in VATS patients.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2025

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

First Submitted

Initial submission to the registry

November 14, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

November 15, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

November 14, 2025

Last Update Submit

December 14, 2025

Conditions

Keywords

Serratus posterior superior intercostal plane blockerector spinae plane blockpain managementVideo-assisted thoracoscopic surgery (VATS)

Outcome Measures

Primary Outcomes (1)

  • opioid consumption

    Tramadol will be prepared as 5mg/ml and patient-controlled analgesia will be administered without basal infusion, with a locking time of 20 minutes and a bolus dose of 10mg.

    0, 2, 4, 8, 16 and 24 hours

Secondary Outcomes (4)

  • Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")

    0, 2, 4, 8, 16 and 24 hours

  • Global recovery scoring system (patient satisfaction scale)- QoR-15

    The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 24th hour.

  • Brief Pain Inventory

    postoperative third month

  • Hospital Anxiety and Depression Scale (HADS)

    On the morning of surgery and at the 3rd postoperative month

Study Arms (2)

Serratus posterior superior intercostal plane block (SPSIPB)

ACTIVE COMPARATOR
Other: Postoperative analgesia management(SPSIPB)

Erector spinae plane block

ACTIVE COMPARATOR
Other: Postoperative analgesia management(ESPB)

Interventions

A high-frequency linear ultrasound probe (GE ML6-15-D Matrix Linear) will be covered with a sterile sheath, and the T3 level will be identified just above the medial border of the scapula. After visualizing the trapezius, rhomboid major, and serratus posterior superior muscles (from superficial to deep), 30 mL of 0.25% bupivacaine (Buvicaine 0.5%®, Polifarma, Tekirdağ, Türkiye) containing 7.5 µg epinephrine (1:200,000) (Adrenalin Bas Galen®; Galen, İstanbul, Türkiye) will be administered as the local anesthetic solution.

Serratus posterior superior intercostal plane block (SPSIPB)

A high-frequency linear ultrasound probe (GE ML6-15-D Matrix Linear) will be covered with a sterile sheath. At the T5 vertebral level, the erector spinae muscle layers and the transverse process of the T5 vertebra, located immediately beneath them, will be identified. After confirming the transverse process, 30 mL of 0.25% bupivacaine (Buvicaine 0.5%®, Polifarma, Tekirdağ, Türkiye) containing 7.5 µg epinephrine (1:200,000) (Adrenalin Bas Galen®; Galen, İstanbul, Türkiye) will be administered as the local anesthetic solution.

Erector spinae plane block

Eligibility Criteria

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

You may qualify if:

  • Patients aged 18-65 years with ASA physical status I-III who will undergo elective video-assisted thoracoscopic surgery (VATS) will be included.

You may not qualify if:

  • Patients who do not consent to participate in the study
  • Patients with coagulopathy
  • Patients with a history of local anesthetic allergy or toxicity
  • Patients with hepatic or renal failure
  • Patients with uncontrolled diabetes
  • Patients with uncontrolled hypertension
  • Mentally disabled patients
  • Patients receiving chronic pain treatment (opioid users)
  • Patients using antidepressant medication
  • Patients with neuropathic pain
  • Mentally disabled patients
  • Presence of infection at the injection site
  • Pregnant or breastfeeding women, or those with suspected pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa City Hospital

Bursa, Nilüfer, 16110, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Mehta S, Jen TTH, Hamilton DL. Regional analgesia for acute pain relief after open thoracotomy and video-assisted thoracoscopic surgery. BJA Educ. 2023 Aug;23(8):295-303. doi: 10.1016/j.bjae.2023.05.001. Epub 2023 Jun 22. No abstract available.

    PMID: 37465231BACKGROUND
  • Wong MKH, Sit AKY, Au TWK. Minimally invasive thoracic surgery: beyond surgical access. J Thorac Dis. 2018 Jun;10(Suppl 16):S1884-S1891. doi: 10.21037/jtd.2018.05.196.

    PMID: 30026975BACKGROUND
  • Steinthorsdottir KJ, Wildgaard L, Hansen HJ, Petersen RH, Wildgaard K. Regional analgesia for video-assisted thoracic surgery: a systematic review. Eur J Cardiothorac Surg. 2014 Jun;45(6):959-66. doi: 10.1093/ejcts/ezt525. Epub 2013 Nov 27.

    PMID: 24288340BACKGROUND

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
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc prof

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 18, 2025

Study Start

November 15, 2025

Primary Completion

May 15, 2026

Study Completion

May 15, 2026

Last Updated

December 16, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared

Locations