NCT06260137

Brief Summary

The goal of this clinical study is to compare the effectiveness of the Rhomboid Intercostal Block and Sub-Servitus plan block and the effectiveness of the Rhomboid intercostal block in patients with video-supported thoracoscopic surgery. The main question it aims to answer is: Which of these two blocks more effectively reduces the patients' pain?

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

July 10, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

12 months

First QC Date

February 1, 2024

Last Update Submit

February 14, 2024

Conditions

Postoperative Analgesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative analgesia

    Patients' VAS scores and additional analgesic needs in the first 48 hours will be evaluated. VAS (visual pain scale) corresponds to a value between 0 and 10. A value of 0 means no pain, and a value of 10 is the most severe pain.

    first 48 hours postoperatively

Study Arms (2)

Rhomboid İntercostal Block (RIB)

ACTIVE COMPARATOR
Procedure: Rhomboid intercostal block

Rhomboid intercostal and subserratus plane block (RISS)

ACTIVE COMPARATOR
Procedure: Rhomboid intercostal and subserratus plane block

Interventions

Rhomboid intercostal blockPROCEDURE

Patients will be injected with a local anesthetic drug under the rhomboid intercostal muscle before surgery.

Rhomboid İntercostal Block (RIB)
Rhomboid intercostal and subserratus plane blockPROCEDURE

Patients will be injected with a local anesthetic drug under the rhomboid intercostal muscle and the serrates anterior muscle before surgery.

Rhomboid intercostal and subserratus plane block (RISS)

Eligibility Criteria

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

You may qualify if:

  • Patients in American Society of Anesthesiologists (ASA) classes I, II and III for whom VATS is planned

You may not qualify if:

  • Known or suspected local anesthetic allergy
  • coagulopathy
  • injection site infection
  • history of thoracic surgery
  • serious neurological or psychiatric disorder
  • severe cardiovascular disease
  • liver failure
  • renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hastane

Bursa, 16210, Turkey (Türkiye)

Location

Study Design

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

Study Record Dates

First Submitted

February 1, 2024

First Posted

February 15, 2024

Study Start

July 10, 2023

Primary Completion

July 1, 2024

Study Completion

August 1, 2024

Last Updated

February 15, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)