- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03650868
The Effect of Thoracal Paravertebral Block on Seroma Reduction in Breast Surgery
February 27, 2019 updated by: Alparslan Kus, Kocaeli University
The Effect of Thoracal Paravertebral Block on Seroma Reduction in Breast Surgery, a Randomised Controlled Trial
Thoracal paravertebral block (TPVB) is a commonly prefferred regional anesthesia technique to provide postoperative analgesia.
In addition, the successful use of TPVB is reported for some seroma related pain cases.
Postoperative analgesia in breast surgery is a difficult and overworked issue due to etensive surgery and complex innervation of the breast and in addition to this complex mechanisms, seroma accumulation has a negative effect for patients postoperatively.
With this study, the investigators aimed to study the effect of TPVB on seroma reduction for breast cancer surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
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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Kocaeli, Turkey
- Kocaeli 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 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 18-70 years of agge
- ASA I-II
- Undergoing elective breast cancer surgery
Exclusion Criteria:
- obesity (body mass index >35 kg/m2)
- infection of the skin at the site of needle puncture area
- patients with known allergies to any of the study drugs
- coagulopathy
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: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
No intervention will be applied to control group
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Experimental: TPVB group
Thoracal paravertebral block will be performed with 20cc of 0,25% bupivacaine preoperatively.
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Thoracal paravertebral block will be performed before the surgery to the TPVB group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seroma quantitiy
Time Frame: 24 hour postoperatively.
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Seroma quantitiy of all patients will be recorded after 24 hour postoperatively.
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24 hour postoperatively.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alparslan Kus, Kocaeli Üniversitesi Tıp Fakültesi
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)
September 1, 2018
Primary Completion (Actual)
February 1, 2019
Study Completion (Actual)
February 26, 2019
Study Registration Dates
First Submitted
August 27, 2018
First Submitted That Met QC Criteria
August 28, 2018
First Posted (Actual)
August 29, 2018
Study Record Updates
Last Update Posted (Actual)
February 28, 2019
Last Update Submitted That Met QC Criteria
February 27, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KIA 2018/155
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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