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

Breast Cancer Clinical Trial

Official title:

The Effect of Thoracal Paravertebral Block on Seroma Reduction in Breast Surgery, a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03650868
• Other study ID #: KIA 2018/155
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: February 26, 2019

Study information

• Verified date: February 2019
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 26, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Seroma

Intervention

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

Locations

Country	Name	City	State
Turkey	Kocaeli University	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroma quantitiy	Seroma quantitiy of all patients will be recorded after 24 hour postoperatively.	24 hour postoperatively.