NCT03650868

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2019

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

5 months

First QC Date

August 27, 2018

Last Update Submit

February 27, 2019

Conditions

SeromaBreast Cancer

Keywords

Thoracal Paravertebral BlockBreast SurgerySeroma Reduction

Outcome Measures

Primary Outcomes (1)

  • Seroma quantitiy

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

    24 hour postoperatively.

Study Arms (2)

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

Thoracal paravertebral blockPROCEDURE

Thoracal paravertebral block will be performed before the surgery to the TPVB group.

TPVB group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of agge
  • ASA I-II
  • Undergoing elective breast cancer surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

SeromaBreast Neoplasms

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Alparslan Kus

    Kocaeli Üniversitesi Tıp Fakültesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 27, 2018

First Posted

August 29, 2018

Study Start

September 1, 2018

Primary Completion

February 1, 2019

Study Completion

February 26, 2019

Last Updated

February 28, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)