Comparison of Two Different Methods for Reducing Pain After Lung Surgery

February 14, 2024 updated by: Ferhat Ustuner, Uludag University

Comparison of the Effectiveness of the Combination of Rhomboid Intercostal and Sub-serratus Plan Block and Rhomboid Intercostal Block for Postoperative Analgesis in Video-assisted Thoracopic Surgery (VATS)

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?

Study Overview

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bursa, Turkey, 16210
        • Hastane

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rhomboid İntercostal Block (RIB)
Patients will be injected with a local anesthetic drug under the rhomboid intercostal muscle before surgery.
Active Comparator: Rhomboid intercostal and subserratus plane block (RISS)
Patients will be injected with a local anesthetic drug under the rhomboid intercostal muscle and the serrates anterior muscle before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative analgesia
Time Frame: first 48 hours postoperatively
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Estimated)

February 15, 2024

Study Record Updates

Last Update Posted (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • UludagThorax

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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