Breast ReductionNCT07432256
Parasternal Block Added to Serratus Anterior Plane Block in Breast Reduction Surgery
A study testing Serratus Anterior Plane Block (SAPB) and Serratus Anterior Plane Block (SAPB) and parasternal intercostal plane block in people with Breast Reduction and Postoperative Pain, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effect of adding a Superficial Parasternal Intercostal Plane Block (PIPB) to the Serratus Anterior Plane Block (SAPB) on postoperative pain control in patients undergoing breast reduction surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Reduction, Postoperative Pain, Opioid Consumption
- What is being tested?
- Serratus Anterior Plane Block (SAPB) and Serratus Anterior Plane Block (SAPB) and parasternal intercostal plane block
- Type of treatment
- Injection or infusion, 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 May 2024to 1 Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18-65 years
- Scheduled for elective breast reduction surgery under general anesthesia
- American Society of Anesthesiologists (ASA) physical status I-III
- Ability to understand the study and provide written informed consent
Who cannot join
- Patient refusal
- Known allergy to local anesthetics
- Coagulopathy or ongoing anticoagulant therapy
- Infection at the block site
- Chronic opioid use or opioid dependence
- Severe hepatic or renal insufficiency
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bulent Ecevit University Hospital
Zonguldak, Maltepe
About this study
Official title: The Effect of Adding a Parasternal Intercostal Plane Block to a Serratus Anterior Plane Block on Postoperative Opioid Consumption in Breast Reduction Surgery
This study aims to evaluate the effect of adding a Superficial Parasternal Intercostal Plane Block (PIPB) to the Serratus Anterior Plane Block (SAPB) on postoperative pain control in patients undergoing breast reduction surgery under general anesthesia. Effective postoperative analgesia is essential to reduce opioid consumption and improve recovery.
All patients will receive standard general anesthesia. Patients will be allocated into three groups: a control group receiving no regional block, a group receiving SAPB alone, and a group receiving SAPB combined with PIPB. The primary outcome of the study is total opioid consumption within the first 24 hours after surgery. Secondary outcomes include postoperative pain scores, Quality of Recovery-15 (QoR-15) scores, and intraoperative remifentanil consumption.
The study aims to determine whether SAPB reduces postoperative opioid requirements compared to no block, and whether adding PIPB provides additional analgesic benefit by blocking the anterior cutaneous branches of the intercostal nerves. The findings may contribute to improving multimodal analgesia strategies in breast surgery.
- Conditions
- Breast Reduction, Postoperative Pain, Opioid Consumption
- Being tested
- Serratus Anterior Plane Block (SAPB), Serratus Anterior Plane Block (SAPB) and parasternal intercostal plane block
- Keywords
- serratus anterior plane block, parasternal intercostal plane block, breast reduction surgery, pain management, postoperative pain, QoR-15
- 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 Anterior Plane Block (SAPB)Procedure or surgery
injection local anesthetic between 5th rib and serratus anterior muscle
Serratus Anterior Plane Block (SAPB) and parasternal intercostal plane blockProcedure or surgery
both injection local anesthetic between 5th rib and serratus anterior muscle at midaxillary line and between 4th costal cartilage and pectoralis major muscle at next to the sternum
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | patients receive standard general anesthesia |
| Serratus Anterior Plane Block | Active comparator | patients receive an ultrasound guided anterior serratus plane block in addition to general anesthesia before surgery Receives: Procedure: Serratus Anterior Plane Block (SAPB) |
| Serratus Anterior Plane Block + Parasternal Intercostal Plane Block | Active comparator | patients receive an ultrasound guided anterior serratus plane block combined with a parasternal plane block in addition to general anesthesia before surgery Receives: Procedure: Serratus Anterior Plane Block (SAPB) and parasternal intercostal plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total postoperative opioid consumption in the first 24 hours
Total opioid consumption during the first 24 postoperative hours will be recorded and compared between the study groups.
Measured: First 24 hours after surgery
Secondary outcomes (2)
Quality of recovery by using QoR-15 questionnaire
Measured: postoperative 24th hour
Pain Scores
using NRS Scale
Measured: postoperative 0, 1, 2, 6, 12, 24 th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 May 2024
- Primary completion25 Aug 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReductionStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, emine bayraktar, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432256
- Sponsor's protocol ID
- 2024/08-6
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 25 Feb 2026
- 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 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding a Parasternal Intercostal Plane Block to a Serratus Anterior Plane Block on Postoperative Opioid Consumption in Breast Reduction Surgery
- ClinicalTrials.gov ID
- NCT07432256
- Acronym / sponsor ID
- 2024/08-6
- Conditions
- Breast Reduction, Postoperative Pain, Opioid Consumption
- Keywords
- serratus anterior plane block, parasternal intercostal plane block, breast reduction surgery, pain management, postoperative pain, QoR-15
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 25 Feb 2026 (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.
This study aims to evaluate the effect of adding a Superficial Parasternal Intercostal Plane Block (PIPB) to the Serratus Anterior Plane Block (SAPB) on postoperative pain control in patients undergoing breast reduction surgery under general anesthesia. Effective postoperative analgesia is essential to reduce opioid consumption and improve recovery.
All patients will receive standard general anesthesia. Patients will be allocated into three groups: a control group receiving no regional block, a group receiving SAPB alone, and a group receiving SAPB combined with PIPB. The primary outcome of the study is total opioid consumption within the first 24 hours after surgery. Secondary outcomes include postoperative pain scores, Quality of Recovery-15 (QoR-15) scores, and intraoperative remifentanil consumption.
The study aims to determine whether SAPB reduces postoperative opioid requirements compared to no block, and whether adding PIPB provides additional analgesic benefit by blocking the anterior cutaneous branches of the intercostal nerves. The findings may contribute to improving multimodal analgesia strategies in breast surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –patients receive standard general anesthesia |
| Serratus Anterior Plane Block | Active comparator | Procedure: Serratus Anterior Plane Block (SAPB)patients receive an ultrasound guided anterior serratus plane block in addition to general anesthesia before surgery |
| Serratus Anterior Plane Block + Parasternal Intercostal Plane Block | Active comparator | Procedure: Serratus Anterior Plane Block (SAPB) and parasternal intercostal plane blockpatients receive an ultrasound guided anterior serratus plane block combined with a parasternal plane block in addition to general anesthesia before surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients aged 18-65 years
- Scheduled for elective breast reduction surgery under general anesthesia
- American Society of Anesthesiologists (ASA) physical status I-III
- Ability to understand the study and provide written informed consent
Key exclusion criteria (7 listed)
- Patient refusal
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 Block (SAPB)injection local anesthetic between 5th rib and serratus anterior muscle | Procedure or surgery | Serratus Anterior Plane Block |
| Serratus Anterior Plane Block (SAPB) and parasternal intercostal plane blockboth injection local anesthetic between 5th rib and serratus anterior muscle at midaxillary line and between 4th costal cartilage and pectoralis major muscle at next to the sternum | Procedure or surgery | Serratus Anterior Plane Block + Parasternal Intercostal Plane Block |
Primary outcome
Total postoperative opioid consumption in the first 24 hours
Time frame: First 24 hours after surgery
Total opioid consumption during the first 24 postoperative hours will be recorded and compared between the study groups.
2 secondary outcomes
Quality of recovery by using QoR-15 questionnaire
Time frame: postoperative 24th hour
Pain Scores
Time frame: postoperative 0, 1, 2, 6, 12, 24 th hour
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 25 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Reduction
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
RecruitingPhase 2
Dose-Reduced Docetaxel With Cyclophosphamide for the Treatment of Vulnerable Older Women With Stage I-III HER2 Negative Breast Cancer, the DOROTHY Trial
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
RecruitingPhase 2
FLASH-Breast: Evaluating the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Not yet recruiting
Culinary And Lifestyle Medicine Education for Cancer Risk Reduction in Survivors of Breast Cancer
Breast Cancer
Active, not recruitingPhase 2
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
Risk Reduction, Breast Cancer
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 (SAPB) and Serratus Anterior Plane Block (SAPB) and parasternal intercostal plane block in people with Breast Reduction and Postoperative Pain, 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 7 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 25 Feb 2026. 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 postoperative opioid consumption in the first 24 hours (time frame: First 24 hours 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 25 Feb 2026.