Postoperative PainNCT06948383
SPSIPB vs. SAPB in Breast Surgery
A study testing Serratus Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block in people with Postoperative Pain and Quality of Recovery, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
The effects of the newly defined serratus posterior superior intercostal plane block and serratus anterior plane block on postoperative analgesia and quality of recovery in women undergoing breast surgery will be investigated. 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
- Postoperative Pain, Quality of Recovery
- What is being tested?
- Serratus Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients who have received informed consent form Patients who will undergo Breast Cancer Surgery aged between 18-65
Who cannot join
- <18 years and >65 years
- ASA ≥ IV
- History of allergy to local anesthetics
- Clinical diagnosis of coagulation disorders
- Infection near the entry site
- Chronic analgesic use Patients who will undergo bilateral Breast Cancer Surgery
Show all 9Show fewer
- Body mass index >35
- Clinical diagnosis of Dementia or confusion
- Lack of cooperation
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: Serratus Posterior Superior Intercostal Plane Block Versus Serratus Anterior Plane Block for Breast Surgery: A Randomized Controlled Trial
The effects of the newly defined serratus posterior superior intercostal plane block and serratus anterior plane block on postoperative analgesia and quality of recovery in women undergoing breast surgery will be investigated.
- Conditions
- Postoperative Pain, Quality of Recovery
- Being tested
- Serratus Posterior Superior Intercostal Plane Block, Serratus Anterior Plane Block
- Keywords
- postoperative pain, pain scores, Pain management, Fasial plane blocks
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Posterior Superior Intercostal Plane BlockProcedure or surgery
administer 30 mL %0.25 bupivacain between third costa and serratus posterior superior muscle
Serratus Anterior Plane BlockProcedure or surgery
administer 30 mL %0.25 bupivacain between 5th costa and serratus anterior muscle in midaxiller line
| Study group | Role | What they receive |
|---|---|---|
| Group Control | No intervention | Not described |
| Group SPSIPB | Active comparator | Not described Receives: Procedure: Serratus Posterior Superior Intercostal Plane Block |
| Group SAPB | Active comparator | Not described Receives: Procedure: Serratus Anterior Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative opioid consumption
total opioid consumption during postoperative 24 hours
Measured: up to 24 hour after surgery
Secondary outcomes (2)
Postoperative pain scores
Pain scores evaluate with Numeric rating scale. 0= no pain, 10= unbearable pain
Measured: postoperative 2nd 6th, 12th 24th hour
quality of recovery
Recovery quality will be measured with Quality of recovery-15 questionnaire
Measured: postoperative 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start1 Apr 2025
- Primary completion30 Aug 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Sena BAYTAR, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948383
- Sponsor's protocol ID
- 2025/01-12
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 29 Apr 2025
- 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 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serratus Posterior Superior Intercostal Plane Block Versus Serratus Anterior Plane Block for Breast Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06948383
- Acronym / sponsor ID
- 2025/01-12
- Conditions
- Postoperative Pain, Quality of Recovery
- Keywords
- postoperative pain, pain scores, Pain management, Fasial plane blocks
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 29 Apr 2025 (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 effects of the newly defined serratus posterior superior intercostal plane block and serratus anterior plane block on postoperative analgesia and quality of recovery in women undergoing breast surgery will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Control | No intervention | – |
| Group SPSIPB | Active comparator | Procedure: Serratus Posterior Superior Intercostal Plane Block |
| Group SAPB | Active comparator | Procedure: Serratus Anterior Plane Block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have received informed consent form Patients who will undergo Breast Cancer Surgery aged between 18-65
Key exclusion criteria (9 listed)
- <18 years and >65 years
- ASA ≥ IV
- History of allergy to local anesthetics
- Clinical diagnosis of coagulation disorders
- Infection near the entry site
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 Posterior Superior Intercostal Plane Blockadminister 30 mL %0.25 bupivacain between third costa and serratus posterior superior muscle | Procedure or surgery | Group SPSIPB |
| Serratus Anterior Plane Blockadminister 30 mL %0.25 bupivacain between 5th costa and serratus anterior muscle in midaxiller line | Procedure or surgery | Group SAPB |
Primary outcome
postoperative opioid consumption
Time frame: up to 24 hour after surgery
total opioid consumption during postoperative 24 hours
2 secondary outcomes
Postoperative pain scores
Time frame: postoperative 2nd 6th, 12th 24th hour
quality of recovery
Time frame: postoperative 24 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- 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 Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block in people with Postoperative Pain and Quality of Recovery, 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 1 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
postoperative opioid consumption (time frame: up to 24 hour after surgery). 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 29 Apr 2025.