Breast DiseasesNCT06657092
Ultrasound Guided Erector Spinae Plane Block
A study testing Erector Spinae Plane Block and Standart therapy in people with Breast Diseases, run by Gözde Gamze Uzun at 1 site in Turkey (Türkiye).
Trial summary
Patients were randomized into two groups, ESP and control. Single-shot ultrasound (US)-guided ESP block with 20 ml 0.25% bupivacaine at the T4 vertebral level was performed preoperatively to all patients in the ESP group. The control group received no intervention. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Diseases
- What is being tested?
- Erector Spinae Plane Block and Standart therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2020to 30 Dec 2022
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 age
- Patients who scheduled for bilateral reduction mammoplasty
- ASA Class I-II
Who cannot join
- 1. Coagulopaty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Erector Spinae Plane Efficacy of Erector Spinae Plane Block for Analgesia in Breast Surgery
Patients were randomized into two groups, ESP and control. Single-shot ultrasound (US)-guided ESP block with 20 ml 0.25% bupivacaine at the T4 vertebral level was performed preoperatively to all patients in the ESP group. The control group received no intervention. Patients in both groups were provided with intravenous patient-controlled analgesia device containing morphine for postoperative analgesia.
- Conditions
- Breast Diseases
- Being tested
- Erector Spinae Plane Block, Standart therapy
- Medical subject headings
- Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
Also called espb group
Single-shot ultrasound (US)-guided ESP block with 20 ml 0.25% bupivacaine ( Marcaine ) at the T4 vertebral level will be performed.
Standart therapyProcedure or surgery
Postoperative 0.5 mg/kg morphine and 1 gr paracetamol will be admistered intravenously in the operation theatre and intravenous patient controlled analgesia (PCA) will be performed in the plastic surgery ward postoperatively
| Study group | Role | What they receive |
|---|---|---|
| erector spinae plane block group | Active comparator | Single-shot ultrasound (US)-guided ESP block with 20 ml 0.25% bupivacaine at the T4 vertebral level Receives: Procedure: Erector Spinae Plane Block |
| control group | Active comparator | morphine pca to patient Receives: Procedure: Standart therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption
Patients in both groups will receive opioid in postoperative period. Total opioid consumption in miligrams will be compared
Measured: Postoperative total opioid consumption in miligrams will be recorded at hour 24
Secondary outcomes (1)
Intraoperative opioid consumption
The amount of remifentanyl administered to patients via intravenous infusion during the operation in micrograms, will be recorded.
Measured: At the end of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start4 Mar 2020
- Primary completion20 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast DiseasesStudies 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
- Parallel groups
- Model description
- Patients were randomized into two groups, ESPB and control.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gözde Gamze Uzun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gözde Gamze Uzun, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657092
- Sponsor's protocol ID
- Kocaeli Univercity
- Status last verified
- Feb 2023
- First submitted
- 22 Feb 2023
- Last updated
- 28 Oct 2024
- 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 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Erector Spinae Plane Efficacy of Erector Spinae Plane Block for Analgesia in Breast Surgery
- ClinicalTrials.gov ID
- NCT06657092
- Acronym / sponsor ID
- Kocaeli Univercity
- Conditions
- Breast Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Gözde Gamze UzunUniversity, hospital or other
- Study start
- 4 Mar 2020 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 24 Oct 2024 (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.
Patients were randomized into two groups, ESP and control. Single-shot ultrasound (US)-guided ESP block with 20 ml 0.25% bupivacaine at the T4 vertebral level was performed preoperatively to all patients in the ESP group. The control group received no intervention. Patients in both groups were provided with intravenous patient-controlled analgesia device containing morphine for postoperative analgesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients were randomized into two groups, ESPB and control.
| Arm | Type | Receives |
|---|---|---|
| erector spinae plane block group | Active comparator | Procedure: Erector Spinae Plane BlockSingle-shot ultrasound (US)-guided ESP block with 20 ml 0.25% bupivacaine at the T4 vertebral level |
| control group | Active comparator | Procedure: Standart therapymorphine pca to patient |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 age
- Patients who scheduled for bilateral reduction mammoplasty
- ASA Class I-II
Key exclusion criteria (1 listed)
- 1. Coagulopaty
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 |
|---|---|---|
| Erector Spinae Plane BlockAlso: espb groupSingle-shot ultrasound (US)-guided ESP block with 20 ml 0.25% bupivacaine ( Marcaine ) at the T4 vertebral level will be performed. | Procedure or surgery | erector spinae plane block group |
| Standart therapyPostoperative 0.5 mg/kg morphine and 1 gr paracetamol will be admistered intravenously in the operation theatre and intravenous patient controlled analgesia (PCA) will be performed in the plastic surgery ward postoperatively | Procedure or surgery | control group |
Primary outcome
Total opioid consumption
Time frame: Postoperative total opioid consumption in miligrams will be recorded at hour 24
Patients in both groups will receive opioid in postoperative period. Total opioid consumption in miligrams will be compared
1 secondary outcome
Intraoperative opioid consumption
Time frame: At the end of the operation
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 Oct 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block and Standart therapy in people with Breast Diseases, run by Gözde Gamze Uzun 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 1 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 Oct 2024. 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?
Total opioid consumption (time frame: Postoperative total opioid consumption in miligrams will be recorded at hour 24). 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 Oct 2024.