- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06260137
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
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Sponsor
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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