ClinicalTrials.gg
CompletedNCT03650868Updated Feb 28, 2019

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

An interventional study of Thoracal paravertebral block in Seroma and Breast Cancer, sponsored by Kocaeli University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-28.

Sponsored by Kocaeli University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Seroma
  • Breast Cancer

Keywords

  • Thoracal Paravertebral Block
  • Breast Surgery
  • Seroma Reduction
03

In context

Seroma

101 studies on the registry are indexed under Seroma; 22 are open to participants now.

This study's enrollment of 40 is below the median of 100 across 92 interventional studies indexed under Seroma.

Browse Seroma studies →

Lead sponsor

Kocaeli University is the lead sponsor of 215 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18-70 years of agge
  • Undergoing elective breast cancer surgery

Exclusion criteria

Exclusion Criteria:

  • obesity ( >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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • No intervention
    Control Group

    No intervention will be applied to control group

  • Experimental
    TPVB group

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

    Procedure: Thoracal paravertebral block

Interventions

  • ProcedureThoracal paravertebral block

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

06

What researchers measure

Primary outcomes

  1. Seroma quantitiy

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

    Time frame: 24 hour postoperatively.

07

Study locations

1 site
  • Kocaeli University
    Kocaeli, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2018 to primary completion in Feb 2019, 5 months.

Of 43 non-industry interventional studies with no phase under Seroma, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 65. This study's 5 months is below that.

Counting every sponsor, half of 44 studies reached it within 34 months; a quarter within 17 and three quarters within 65.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2018
First posted
Aug 29, 2018
StartActual
Sep 1, 2018
Primary completionActual
Feb 1, 2019
CompletionActual
Feb 26, 2019
Last update
Feb 28, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03650868
Lead sponsor
Kocaeli University
Responsible party
Alparslan Kus (Associate Professor, Kocaeli University) — Principal investigator
First posted
Aug 29, 2018
Start date
Sep 1, 2018
Primary completion
Feb 1, 2019
Completion
Feb 26, 2019
Last update
Feb 28, 2019

Study contacts

Alparslan Kus
principal investigator · Kocaeli Üniversitesi Tıp Fakültesi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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