Hemodynamic InstabilityNCT04824833
Effects of US-guided SAPB During Breast Surgery
A study testing Serratus anterior plane block in people with Hemodynamic Instability and Opioid Use, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
The serratus anterior plan (SAP) block is a technique that has recently gained popularity in the context of breast surgery. SAP block resulted in better hemodynamic stability, early ambulation and shorter hospital stay, as well as hospital costs for postoperative breast patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hemodynamic Instability, Opioid Use, Block
- What is being tested?
- Serratus anterior plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 30 Sep 2021
- 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18-75,
- ASA I-II-III risk group
- Patients who underwent breast surgery under general anesthesia, who underwent serratus anterior plan block for analgesia, or who were provided analgesia with conventional methods
- Patients whose informed consent was read and whose consent was obtained
Who cannot join
- who do not want to participate in the study,
- ASA IV-V patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University medicine faculty
Zonguldak, Kozlu, 67600
About this study
Official title: The Effects of Ultrasound-guided Serratus Anterior Plane Block on Intraoperative Opioid Consumption and Hemodynamic Stability During Breast Surgery: A Randomized Controlled Study
The serratus anterior plan (SAP) block is a technique that has recently gained popularity in the context of breast surgery. SAP block resulted in better hemodynamic stability, early ambulation and shorter hospital stay, as well as hospital costs for postoperative breast patients.
We aimed to investigate the effects of the serratus anterior plane block in women undergoing breast surgery, in the intraoperative period.
- Conditions
- Hemodynamic Instability, Opioid Use, Block, Breast Cancer
- Being tested
- Serratus anterior plane block
- Keywords
- hemodynamics, serratus anterior plane block, opioid consumption, breast surgery
- Medical subject headings
- Bites and Stings, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus anterior plane blockProcedure or surgery
local anesthetic application between serratus anterior muscle and 5th rib
| Study group | Role | What they receive |
|---|---|---|
| Serratus anterior plane block | Active comparator | Not described Receives: Procedure: Serratus anterior plane block |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamic stability
effect of serratus anterior plane block on hemodynamic stability during breast surgery
Measured: during surgery
opioid consumption
effect of serratus anterior plane block on opioid consumption during breast surgery
Measured: during surgery
Secondary outcomes (1)
emergence time
the time period between surgical incision closure and extubation.
Measured: end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Mar 2021
- Primary completion31 Aug 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic InstabilityStudies 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
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağdaş Baytar, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824833
- Sponsor's protocol ID
- 2021/03-12
- Status last verified
- Feb 2022
- First submitted
- 29 Mar 2021
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baytar C, Aktas B, Aydin BG, Piskin O, Cakmak GK, Ayoglu H. The effects of ultrasound-guided serratus anterior plane block on intraoperative opioid consumption and hemodynamic stability during breast surgery: A randomized controlled study. Medicine (Baltimore). 2022 Sep 2;101(35):e30290. doi: 10.1097/MD.0000000000030290.
PubMed 36107549
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ultrasound-guided Serratus Anterior Plane Block on Intraoperative Opioid Consumption and Hemodynamic Stability During Breast Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04824833
- Acronym / sponsor ID
- 2021/03-12
- Conditions
- Hemodynamic Instability, Opioid Use, Block, Breast Cancer
- Keywords
- hemodynamics, serratus anterior plane block, opioid consumption, breast surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 1 Apr 2021 (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.
The serratus anterior plan (SAP) block is a technique that has recently gained popularity in the context of breast surgery. SAP block resulted in better hemodynamic stability, early ambulation and shorter hospital stay, as well as hospital costs for postoperative breast patients.
We aimed to investigate the effects of the serratus anterior plane block in women undergoing breast surgery, in the intraoperative period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus anterior plane block | Active comparator | Procedure: Serratus anterior plane block |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between the ages of 18-75,
- ASA I-II-III risk group
- Patients who underwent breast surgery under general anesthesia, who underwent serratus anterior plan block for analgesia, or who were provided analgesia with conventional methods
- Patients whose informed consent was read and whose consent was obtained
Key exclusion criteria (2 listed)
- who do not want to participate in the study,
- ASA IV-V patients
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 |
|---|---|---|
| Serratus anterior plane blocklocal anesthetic application between serratus anterior muscle and 5th rib | Procedure or surgery | Serratus anterior plane block |
Primary outcome
hemodynamic stability
Time frame: during surgery
effect of serratus anterior plane block on hemodynamic stability during breast surgery
opioid consumption
Time frame: during surgery
effect of serratus anterior plane block on opioid consumption during breast surgery
1 secondary outcome
emergence time
Time frame: end of the surgery
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 16 Feb 2022.
- Derived from this study: PubMed 36107549Baytar C, Aktas B, Aydin BG, Piskin O, Cakmak GK, Ayoglu H. The effects of ultrasound-guided serratus anterior plane block on intraoperative opioid consumption and hemodynamic stability during breast surgery: A randomized controlled study. Medicine (Baltimore). 2022 Sep 2;101(35):e30290. doi: 10.1097/MD.0000000000030290.
- 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 Serratus anterior plane block in people with Hemodynamic Instability and Opioid Use, run by Zonguldak Bulent Ecevit 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 4 inclusion and 2 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 16 Feb 2022. 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?
hemodynamic stability (time frame: during surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04824833, which also lists 1 linked publication.
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 16 Feb 2022.