- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05061667
Thoracic Paravertebral Block Versus Rhomboid Block for Postoperative Pain Control in Thoracic Surgeries
January 19, 2022 updated by: Koç University
The main aim of this study is to compare thoracic paravertebral block and rhomboid block for postoperative analgesia and analgesic usage in thoracic surgeries.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients with scheduled thoracic surgery are going to be enrolled for this study.
Patients will be randomized and separated in two groups.
Group I will receive thoracic paravertebral block, group II will receive rhomboid block.
Each group will receive patient controlled analgesia with intravenous fentanyl.
Patients will be monitored at postoperative 1st, 3rd, 6th, 12th, 24th hours and their VAS scores, adverse reactions like nausea and vomiting, total analgesic usage, additional analgesic need and time of the first report of pain will be filed.
Then the two groups will be compared and evaluated.
Study Type
Interventional
Enrollment (Actual)
88
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
-
-
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Istanbul, Turkey, 34010
- Koç University
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-
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
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients scheduled for general thoracic surgery
- ASA I-III
Exclusion Criteria:
- Patients without consent
- Emergency surgeries
- Pregnancy
- Coagulopathies and bleeding diathesis
- Allergy to local anesthetics
- Local skin infection at the puncture site
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group I
Group I will consist of randomly assigned patients scheduled for thoracic surgery.
These patients will recieve paravertebral block which is already proven to be effective in postoperative pain.
After applying standart monitors to the patient and proper positioning in the operating room, paravertebral block will be performed at the planned surgical side using high frequency (8-18 MHz) linear probe of GE Logiq S7 (General Electric Healthcare, Little Chalfont, United Kingdom).
20 ml of 0.25% bupivacaine will be administered into the paravertebral space at T5-T6 vertebra levels using a 50 mm 22 G block needle (BBraun, Melsungen, Germany).
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Paravertebral block for postoperative analgesia in thoracic surgery
Other Names:
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Experimental: Group II
Group II will consist of randomly assigned patients scheduled for thoracic surgery.
These patients will recieve rhomboid block which is being experimented for its efficacy in postoperative pain.
After applying standart monitors to the patient and proper positioning in the operating room, rhomboid block will be performed at the planned surgical side using high frequency (8-18 MHz) linear probe of GE Logiq S7 (General Electric Healthcare, Little Chalfont, United Kingdom).
20 ml of 0.25% bupivacaine will be administered into the plane between rhomboid muscle and intercostal muscles, medial to scapula at T5-T6 vertebra levels using a 50 mm 22 G block needle (BBraun, Melsungen, Germany).
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Rhomboid block for postoperative analgesia in thoracic surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in Visual Analogue Scale (VAS) scores between two groups
Time Frame: 24 hours
|
Statistically significant difference in VAS scores at 1st, 3rd, 6th, 12th, 24th hours between two groups.
On a scale of 0 to 10, where 0 means no pain and 10 means the worst imaginable pain.
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24 hours
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Difference in additional analgesic usage between two groups
Time Frame: 24 hours
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Intravenous patient controlled analgesia usage and additional analgesic dosages will be filed as miligrams or micrograms at 1st, 3rd, 6th, 12th, 24th hours.
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24 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of nausea and vomiting
Time Frame: 24 hours
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Incidence of symptoms like nausea and vomiting will be filed at 1st, 3rd, 6th, 12th, 24th hours.
On a scale of 0 to 1, where 0 means no symptoms and 1 means nausea and vomiting.
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24 hours
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Patient satisfaction
Time Frame: 24 hours
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Patient will be reevaluated at 24th hour for analgesic satisfaction.
On a scale of 0 to 3, where 0 means not satisfied and 3 means satisfied.
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24 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ciftci B, Ekinci M, Atalay YO. Ultrasound-guided rhomboid intercostal block provides effective pain control after video-assisted thoracoscopic surgery: a brief report of three cases. Korean J Anesthesiol. 2021 Aug;74(4):355-357. doi: 10.4097/kja.20538. Epub 2020 Nov 17. No abstract available.
- Longo F, Piliego C, Martuscelli M, Tomaselli E, Crucitti P, Longo F, Agro FE. Rhomboid intercostal and subserratus plane block for intubated uniportal video-assisted thoracoscopic surgery lobectomy. J Clin Anesth. 2020 Oct;65:109881. doi: 10.1016/j.jclinane.2020.109881. Epub 2020 May 26. No abstract available.
- Longo F, Piliego C. Rhomboid intercostal and subserratus plane block for non-intubated video-assisted thoracoscopic surgery. J Clin Anesth. 2020 May;61:109612. doi: 10.1016/j.jclinane.2019.09.006. Epub 2019 Oct 24. No abstract available. Erratum In: J Clin Anesth. 2020 Aug;63:109789.
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)
January 1, 2021
Primary Completion (Actual)
November 1, 2021
Study Completion (Actual)
December 15, 2021
Study Registration Dates
First Submitted
September 22, 2021
First Submitted That Met QC Criteria
September 22, 2021
First Posted (Actual)
September 29, 2021
Study Record Updates
Last Update Posted (Actual)
January 20, 2022
Last Update Submitted That Met QC Criteria
January 19, 2022
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021.066.IRB1.022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data collected for the study, including de-identified individual participant data will be made available to other within 6 months after the publication of this trial, as will additional related documents (study protocol, statistical analysis plan and informed consent form), for academic purposes (e.g., meta-analyses), upon request to the corresponding author, and with a signed data access agreement.
IPD Sharing Time Frame
6 months after the publication
IPD Sharing Access Criteria
Academic purposes
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
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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