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The Effect of Thoracal Paravertebral Block on Seroma Reduction in Breast Surgery

Primary Purpose

Seroma, Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Thoracal paravertebral block
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Seroma focused on measuring Thoracal Paravertebral Block, Breast Surgery, Seroma Reduction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Kocaeli University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

TPVB group

Arm Description

No intervention will be applied to control group

Thoracal paravertebral block will be performed with 20cc of 0,25% bupivacaine preoperatively.

Outcomes

Primary Outcome Measures

Seroma quantitiy
Seroma quantitiy of all patients will be recorded after 24 hour postoperatively.

Secondary Outcome Measures

Full Information

First Posted
August 27, 2018
Last Updated
February 27, 2019
Sponsor
Kirsehir Ahi Evran University
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1. Study Identification

Unique Protocol Identification Number
NCT03650868
Brief Title
The Effect of Thoracal Paravertebral Block on Seroma Reduction in Breast Surgery
Official Title
The Effect of Thoracal Paravertebral Block on Seroma Reduction in Breast Surgery, a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
February 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seroma, Breast Cancer
Keywords
Thoracal Paravertebral Block, Breast Surgery, Seroma Reduction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention will be applied to control group
Arm Title
TPVB group
Arm Type
Experimental
Arm Description
Thoracal paravertebral block will be performed with 20cc of 0,25% bupivacaine preoperatively.
Intervention Type
Procedure
Intervention Name(s)
Thoracal paravertebral block
Intervention Description
Thoracal paravertebral block will be performed before the surgery to the TPVB group.
Primary Outcome Measure Information:
Title
Seroma quantitiy
Description
Seroma quantitiy of all patients will be recorded after 24 hour postoperatively.
Time Frame
24 hour postoperatively.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alparslan Kus
Organizational Affiliation
Kocaeli Üniversitesi Tıp Fakültesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kocaeli University
City
Kocaeli
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Thoracal Paravertebral Block on Seroma Reduction in Breast Surgery

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