The Effect of Thoracal Paravertebral Block on Seroma Redu... | NCT03650868

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

NCT03650868

Sponsor

Kocaeli University

Status

Completed

Last Update Posted

Feb 28, 2019Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Seroma
Breast Cancer

Interventions

Thoracal paravertebral block

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2018Actual

Primary Completion Date

Feb 1, 2019Actual

Completion Date

Feb 26, 2019Actual

First Submitted Date

Aug 27, 2018

First Submission Date that Met QC Criteria

Aug 28, 2018

First Posted Date

Aug 29, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2019

Last Update Posted Date

Feb 28, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Group	No Intervention	No intervention will be applied to control group
TPVB group	Experimental	Thoracal paravertebral block will be performed with 20cc of 0,25% bupivacaine preoperatively.	Procedure: Thoracal paravertebral block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thoracal paravertebral block	Procedure	Thoracal paravertebral block will be performed before the surgery to the TPVB group.	TPVB group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Seroma quantitiy	Seroma quantitiy of all patients will be recorded after 24 hour postoperatively.	24 hour postoperatively.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alparslan Kus	Kocaeli Üniversitesi Tıp Fakültesi	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kocaeli University		Kocaeli			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D049291	Seroma
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided