NCT05618210

Brief Summary

The aim of this study is to compare ultrasound-guided ESBP and Rhomboid block in terms of postoperative pain management, postoperative opioid consumption and complications in patients undergoing lobectomy with VATS.Patients aged 18-75 years, ASA 1-2-3, who gave informed consent to lobectomy with video-assisted thoracic surgery (VATS) method will be included in this study. Patients with contraindications for the application of either method, known chronic pain, local anesthetic allergy, spinal deformity or mental or psychiatric problems that prevent cooperation, taking anticoagulants, and infection at the injection site will not be included in the study. Patients who agree to participate in the study will be randomly assigned to one of the anesthesia groups of the study, which include ESPB (elector spina plane block) (Group 1) or Rhomboid block (Group 2). Randomization will be at a ratio of 1:1 and will be done by the closed-envelope method. Beforehand, a piece of paper with the name of one of the two groups will be placed inside the envelopes and the envelopes will be closed and mixed. A closed envelope will be drawn randomly for each patient before the procedure, and procedures will be carried out according to the group specified on the paper.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

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

Study Start

First participant enrolled

June 15, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 16, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

1.4 years

First QC Date

November 8, 2022

Last Update Submit

February 15, 2026

Conditions

Keywords

ESPBRHOMBOİD BLOCKOPİOİDPOSTOPERATİVE PAIN

Outcome Measures

Primary Outcomes (1)

  • postoperative pain management

    record of postoperative visual analog scala 0-10 values

    postoperatif first 24 hours.

Secondary Outcomes (1)

  • opioid consumption

    postoperatif first 24 hours.

Study Arms (2)

erector spinae plane block group

ACTIVE COMPARATOR

In the ESPB group, after the patients are placed in the prone position, the linear ultrasound probe will be placed in the midline in the transverse plane to visualize the spinous processes, and the transverse process, trapezius, latissimus dorsi and erector spina muscles will be visualized on the side where VATS is planned at the T5 vertebra level. With an 'in-plane' approach, using a 22 gauge 5-8 cm block needle with extension line (Braun, Melsungen, Germany), which can be seen on ultrasound, the skin, subcutaneous and trapezius, latissimus dorsi and erector spina muscles are passed in the cranio-caudal direction and 0.5- After confirming the needle site with 1 ml of saline, the ESPB will be administered with 20 ml of 0.5% bupivacaine by visualizing the local anesthetic spread linearly.

Other: regional anesthesia

Rhomboid block

ACTIVE COMPARATOR

In the rhomboid intercostal block group, after the patients are placed in the prone position, the ipsilateral arm is positioned towards the chest, allowing the scapula to move laterally and the area called auscultation triangle to be opened, and after the skin disinfection of the surgical side; By using a linear ultrasound probe, the rhomboid major and intercostal muscles will be defined in the auscultation triangle region, and a 50-80 mm needle will be injected into the plan between them at the T5-6 level with an in-plane approach with 20 ml of 0.5% bupivacaine and local anesthetic injection.

Other: regional anesthesia

Interventions

in the ESPB group, the linear ultrasound probe was placed in the erector spina muscles were visualized on the side where VATS was planned. block needle can be seen on ultrasound, the skin and erector spina muscles are passed in the cranio-caudal direction. ESPB will be administered with 20 ml of 0.5% bupivacaine by visualizing the local anesthetic spread linearly. In the rhomboid intercostal block group, the ipsilateral arm is positioned towards the chest, allowing the scapula to move laterally and the area called auscultation triangle to be opened, and after the skin disinfection of the surgical side; By using a linear ultrasound probe, the rhomboid major and intercostal muscles will be defined in the auscultation triangle region, and T5-6 level with an in-plane approach with 20 ml of 0.5% bupivacaine and local anesthetic injection.

Rhomboid blockerector spinae plane block group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-75 years, ASA 1-2-3 who gave informed consent

You may not qualify if:

  • Patients with contraindications, known chronic pain, local anesthetic allergy, spinal deformity or mental or psychiatric problems that prevent cooperation, taking anticoagulants, infection at the injection site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativePostoperative Complications

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • MELIHA ORHON ERGUN

    Marmara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

November 8, 2022

First Posted

November 16, 2022

Study Start

June 15, 2022

Primary Completion

October 26, 2023

Study Completion

May 15, 2024

Last Updated

February 18, 2026

Record last verified: 2026-02

Locations