NCT06778642

Brief Summary

In our study, we primarily aimed to compare the postoperative analgesic effectiveness of the Serratus Posterior Superior Intercostal Plane Block and the Serratus Anterior Plane Block, both routinely applied in patients undergoing Video-Assisted Thoracoscopic Surgery (VATS)

Trial Health

35
At Risk

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 May 2025

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

January 12, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

May 15, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2026

Completed
Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

9 months

First QC Date

January 12, 2025

Last Update Submit

May 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Numerical Rating Scale (NRS)

    Numerical Rating Scale (NRS) The Numerical Rating Scale (NRS) is a commonly used pain assessment tool that allows patients to rate their pain intensity on a scale from 0 to 10. 0 indicates no pain. 10 indicates the worst possible pain. Patients are asked to choose a number that best represents their pain level at the time of assessment.

    2 days

Study Arms (2)

Serratus Posterior Superior Intercostal Plane Block Group

ACTIVE COMPARATOR

In this group, the ultrasound device with a linear probe (38 mm, 6 MHz) will be used. The upper medial border of the scapula on the side of the planned surgery will be identified between the 2nd and 7th ribs. A block needle will be inserted medially to the scapula, advancing into the plane between the serratus posterior superior muscle and the intercostal muscles. A total of 30 ml of 0.25% bupivacaine will be injected, with a maximum dose of 2 mg/kg/day. In other words, the injection will be applied under the SPS muscle, between the rib and the SPS muscle.

Procedure: Serratus Posterior Superior Intercostal Plane Block

Serratus Anterior Plane Block Group

ACTIVE COMPARATOR

In this group, the ultrasound device with a linear probe (38 mm, 6 MHz) will be used. The probe will be placed between the anterior and posterior axillary lines, on the side of the planned surgery, between the 2nd and 7th ribs. The block needle will be advanced to the surface or deeper part of the serratus anterior muscle, into the fascial plane. A total of 30 ml of 0.25% bupivacaine will be injected, with a maximum dose of 2 mg/kg/day, underneath the serratus anterior muscle.

Procedure: Serratus Anterior Plane Block

Interventions

Patients undergoing Video-Assisted Thoracoscopic Surgery (VATS) will receive either a Serratus Posterior Superior Intercostal Plane Block (SPSIPB) with bupivacaine after induction and before the surgical procedure begins.

Serratus Posterior Superior Intercostal Plane Block Group

Patients undergoing Video-Assisted Thoracoscopic Surgery (VATS) will receive either a Serratus Anterior Plane Block (SAPB) with bupivacaine after induction and before the surgical procedure begins.

Serratus Anterior Plane Block Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 to 80 years undergoing Video-Assisted Thoracoscopic Surgery (VATS)
  • Scheduled at Uludağ University Faculty of Medicine Hospital Operating Room
  • Classified as ASA I, II, or III according to the American Society of Anesthesiologists (ASA) criteria

You may not qualify if:

  • Allergy to local anesthetics or contraindications to bupivacaine
  • Known or suspected coagulopathy
  • Infection at the injection site
  • History of thoracic surgery
  • Severe neurological or psychiatric disorders
  • Severe cardiovascular disease
  • Liver failure
  • Renal failure (glomerular filtration rate \< 15 ml/min/1.73 m²)
  • Chronic opioid use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The researchers and participants will be double-blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study will include patients aged 18-80 years scheduled for VATS at Uludağ University Medical Faculty Hospital. Patients with ASA I, II, and III classifications will be included. Patients will be randomized into two groups: Group 1: SPSIPB Group 2: SAPB
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

January 12, 2025

First Posted

January 16, 2025

Study Start

May 15, 2025

Primary Completion

February 9, 2026

Study Completion

February 10, 2026

Last Updated

May 15, 2025

Record last verified: 2025-05