NCT07073495

Brief Summary

This prospective observational study aims to compare the effectiveness of Edge Laminar Block (ELB) and Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in managing postoperative pain after Video-Assisted Thoracoscopic Surgery (VATS). The study will evaluate postoperative pain scores (VAS/NRS), opioid consumption, incidence of postoperative nausea and vomiting (PONV), additional analgesic requirements, and patient satisfaction between the two regional analgesic techniques. This research seeks to provide guidance for optimal postoperative pain management in VATS patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 10, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

July 15, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 18, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

July 10, 2025

Last Update Submit

February 12, 2026

Conditions

Keywords

Edge Laminar Block (ELB)Serratus Posterior Superior Intercostal Plane Block (SPSIPB)Video-Assisted Thoracoscopic Surgery (VATS)Postoperative PainPain AssessmentThoracic SurgeryOpioid SparingInterfascial Plane Blocks

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain intensity measured by Visual Analog Scale (VAS) at rest at 2, 6, 12, and 24 hours after surgery.

    Pain intensity will be assessed using the Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. The primary outcome is the comparison of VAS scores between the two groups at specified time points.

    2, 6, 12, and 24 hours postoperatively

Secondary Outcomes (3)

  • Total opioid consumption (in mg morphine equivalents) within the first 24 hours after surgery

    First 24 hours postoperatively

  • Incidence of postoperative complications (e.g., nausea, vomiting, respiratory depression) within 24 hours after surgery.

    First 24 hours postoperatively

  • Patient satisfaction with pain management, assessed by a numerical rating scale (1-5) at 24 hours after surgery.

    24 hours postoperatively

Study Arms (2)

ELB Group

Patients undergoing VATS who received Edge Laminar Block (ELB) for postoperative pain management. ELB involves the injection of local anesthetic at the edge of the thoracic lamina as a regional anesthesia technique. The efficacy and safety of ELB will be evaluated in this group.

SPSIPB Group

Patients undergoing VATS who received Serratus Posterior Superior Intercostal Plane Block (SPSIPB) for postoperative pain management. SPSIPB involves the injection of local anesthetic into the intercostal plane beneath the serratus posterior superior muscle. The efficacy and safety of SPSIPB will be evaluated in this group.

Eligibility Criteria

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

The study population will consist of adult patients (aged 18-75 years) scheduled for elective video-assisted thoracoscopic surgery (VATS) at \[Your Hospital Name/Institution Name\]. These patients will be categorized based on the regional anesthesia technique received (Edge Laminar Block or Serratus Posterior Superior Intercostal Plane Block) for postoperative pain management. Patients with ASA physical status I-III will be included, ensuring a relatively healthy surgical population.

You may qualify if:

  • Adults aged 18-75 years Scheduled for elective video-assisted thoracoscopic surgery (VATS) American Society of Anesthesiologists (ASA) physical status I-III Ability to provide informed consen

You may not qualify if:

  • Known allergy or contraindication to local anesthetics Chronic opioid use or chronic pain conditions Coagulopathy or use of anticoagulant therapy Infection at the injection site Severe hepatic or renal dysfunction Pregnancy or breastfeeding Inability to understand or complete pain assessment scales

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, 06, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Eda Cennet Caferoğlu

Study Record Dates

First Submitted

July 10, 2025

First Posted

July 18, 2025

Study Start

July 15, 2025

Primary Completion

October 15, 2025

Study Completion

December 15, 2025

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations