SeromaNCT03650868
The Effect of Thoracal Paravertebral Block on Seroma Reduction in Breast Surgery
A study testing Thoracal paravertebral block in people with Seroma and Breast Cancer, run by Kocaeli University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Seroma, Breast Cancer
- What is being tested?
- Thoracal paravertebral block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2018to 26 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-70 years of agge
- ASA I-II
- Undergoing elective breast cancer surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Thoracal Paravertebral Block on Seroma Reduction in Breast Surgery, a Randomised Controlled Trial
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.
- Conditions
- Seroma, Breast Cancer
- Being tested
- Thoracal paravertebral block
- Keywords
- Thoracal Paravertebral Block, Breast Surgery, Seroma Reduction
- Medical subject headings
- Seroma, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracal paravertebral blockProcedure or surgery
Thoracal paravertebral block will be performed before the surgery to the TPVB group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Thoracal paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroma quantitiy
Seroma quantitiy of all patients will be recorded after 24 hour postoperatively.
Measured: 24 hour postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start1 Sep 2018
- Primary completion1 Feb 2019
- Study completion26 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeromaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alparslan Kus, Kocaeli University
- Investigators
- Alparslan Kus, Principal investigator, Kocaeli Üniversitesi Tıp Fakültesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650868
- Sponsor's protocol ID
- KIA 2018/155
- Status last verified
- Feb 2019
- First submitted
- 27 Aug 2018
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Thoracal Paravertebral Block on Seroma Reduction in Breast Surgery, a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03650868
- Acronym / sponsor ID
- KIA 2018/155
- Conditions
- Seroma, Breast Cancer
- Keywords
- Thoracal Paravertebral Block, Breast Surgery, Seroma Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 26 Feb 2019 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No intervention will be applied to control group |
| TPVB group | Experimental | Procedure: Thoracal paravertebral blockThoracal paravertebral block will be performed with 20cc of 0,25% bupivacaine preoperatively. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-70 years of agge
- ASA I-II
- Undergoing elective breast cancer surgery
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracal paravertebral blockThoracal paravertebral block will be performed before the surgery to the TPVB group. | Procedure or surgery | TPVB group |
Primary outcome
Seroma quantitiy
Time frame: 24 hour postoperatively.
Seroma quantitiy of all patients will be recorded after 24 hour postoperatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alparslan Kus principal investigator
Kocaeli Üniversitesi Tıp Fakültesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracal paravertebral block in people with Seroma and Breast Cancer, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroma quantitiy (time frame: 24 hour postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.