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

NCT ID: NCT03650868

Last Updated: 2019-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-02-26

Brief Summary

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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

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Conditions

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Seroma Breast Cancer

Keywords

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Thoracal Paravertebral Block Breast Surgery Seroma Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control Group

No intervention will be applied to control group

Group Type NO_INTERVENTION

No interventions assigned to this group

TPVB group

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

Group Type EXPERIMENTAL

Thoracal paravertebral block

Intervention Type PROCEDURE

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

Interventions

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Thoracal paravertebral block

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

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Alparslan Kus

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alparslan Kus

Role: PRINCIPAL_INVESTIGATOR

Kocaeli Üniversitesi Tıp Fakültesi

Locations

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Kocaeli University

Kocaeli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KIA 2018/155

Identifier Type: -

Identifier Source: org_study_id