Breast CancerNCT07579650
Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Mastectomy
A study testing SPSIP Block With Bupivacaine and SPSIP Block With Saline in people with Breast Cancer, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effect of serratus posterior superior intercostal plane (SPSIP) block on postoperative pain, opioid consumption, and analgesic requirements in patients undergoing mastectomy and axillary lymph node dissection Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SPSIP Block With Bupivacaine and SPSIP Block With Saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 May 2026to 30 Sep 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18-65 years
- ASA physical status I-III
- Scheduled for elective unilateral mastectomy with axillary lymph node dissection under general anesthesia
- Able to understand and use the Numeric Rating Scale (NRS) for pain assessment
- Provided written informed consent
Who cannot join
- Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine)
- Coagulopathy, thrombocytopenia (<100,000/mm³), or ongoing anticoagulant/antiplatelet therapy that cannot be discontinued
- Infection or skin lesion at the injection site
- Planned bilateral surgery or additional major surgical procedures
- Chronic pain conditions or regular use of opioids, gabapentinoids, or centrally acting analgesics
- Neurological or psychiatric conditions interfering with pain assessment
Show all 9Show fewer
- History of previous major thoracic or chest wall surgery on the same side
- Pregnancy or breastfeeding
- Refusal to participate or inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Fatma Acil
Diyarbakır, Outside of the US, 21070
Fatma Acil, M.D., +905337225225, acilfatma@gmail.com
About this study
Official title: Mastectomy and Axillary Dissection: Evaluation of the Effect of Serratus Posterior Superior Intercostal Plane Block on Postoperative Analgesia: A Multicenter, Randomized, Placebo-Controlled Trial
This study aims to evaluate the effect of serratus posterior superior intercostal plane (SPSIP) block on postoperative pain, opioid consumption, and analgesic requirements in patients undergoing mastectomy and axillary lymph node dissection
Read the detailed description
This study is a prospective, randomized, placebo-controlled, multicenter clinical trial designed to evaluate the analgesic efficacy of the serratus posterior superior intercostal plane (SPSIP) block in patients undergoing mastectomy with axillary lymph node dissection. Postoperative pain following breast surgery is often significant and may increase opioid consumption and related adverse effects, highlighting the need for effective regional anesthesia techniques.
The SPSIP block is a novel ultrasound-guided interfascial plane block with emerging evidence in thoracic and chest wall procedures; however, its role in breast surgery remains unclear, particularly in placebo-controlled settings. This study aims to determine whether the SPSIP block provides additional benefit as part of a standardized multimodal analgesia approach.
Participants will be randomly assigned to receive either SPSIP block with local anesthetic or a placebo intervention under identical conditions, with blinding applied to all relevant parties. All patients will receive the same perioperative anesthesia and analgesia protocol.
The results of this study are expected to clarify the clinical value of SPSIP block in breast surgery and contribute to the development of evidence-based postoperative pain management strategies.
- Conditions
- Breast Cancer
- Being tested
- SPSIP Block With Bupivacaine, SPSIP Block With Saline
- Keywords
- mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPSIP Block With BupivacaineProcedure or surgery
Participants will receive an ultrasound-guided SPSIP block using bupivacaine.
SPSIP Block With SalineProcedure or surgery
Participants will receive an ultrasound-guided SPSIP block using normal saline under identical conditions.
| Study group | Role | What they receive |
|---|---|---|
| Serratus Posterior Superior Intercostal Plane Block Group | Experimental | Participants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block prior to surgery using 30 mL of 0.25% bupivacaine, in addition to standard general anesthesia and multimodal analgesia. Receives: Procedure: SPSIP Block With Bupivacaine |
| Placebo Group | Placebo comparator | Participants in this group will receive an ultrasound-guided placebo block using 30 mL of normal saline under identical conditions, in addition to standard general anesthesia and multimodal analgesia. Receives: Procedure: SPSIP Block With Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour cumulative opioid consumption
Total opioid consumption within the first 24 hours after surgery, recorded in milligrams.
Measured: 24 hours
Secondary outcomes (7)
Static postoperative pain intensity at rest
Postoperative pain intensity at rest will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: 0, 1, 2, 6, 12, and 24 hours after surgery
Dynamic postoperative pain intensity during movement
Postoperative pain intensity during movement will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: 0, 1, 2, 6, 12, and 24 hours after surgery
Rescue analgesia requirement
Number of patients requiring rescue analgesia and total rescue analgesic consumption.
Measured: Within 24 hours after surgery
Time to first rescue analgesia
Time from the end of surgery to the first administration of rescue analgesia.
Measured: Within 24 hours after surgery
Incidence of postoperative nausea and vomiting (PONV)
Occurrence of nausea and/or vomiting during the postoperative period.
Measured: Within 24 hours after surgery
Quality of Recovery-15 (QoR-15) score
Quality of recovery assessed using the QoR-15 questionnaire. Quality of Recovery-15 (QoR-15) questionnaire was used to assess postoperative recovery. The total score ranges from a minimum of 0 to a maximum of 150. A higher score represents a better recovery outcome (0 = extremely poor recovery, 150 = excellent recovery)
Measured: 24 hours after surgery
Block-related and opioid-related adverse events
Incidence of adverse events including local anesthetic toxicity, hematoma, infection, and opioid-related side effects.
Measured: Within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start16 May 2026
- Primary completion29 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the SPSIP block group or the placebo group using a computer-generated randomization sequence. Both groups will receive identical perioperative management, and outcomes will be compared between parallel groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Acil,MD, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Investigators
- Fatma Acil, M.D., Principal investigator, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579650
- Sponsor's protocol ID
- 27/01/2026-38
- Status last verified
- Aug 2026
- First submitted
- 5 May 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mastectomy and Axillary Dissection: Evaluation of the Effect of Serratus Posterior Superior Intercostal Plane Block on Postoperative Analgesia: A Multicenter, Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07579650
- Acronym / sponsor ID
- 27/01/2026-38
- Conditions
- Breast Cancer
- Keywords
- mastectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 16 May 2026 (actual)
- Primary completion
- 29 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 12 May 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 serratus posterior superior intercostal plane (SPSIP) block on postoperative pain, opioid consumption, and analgesic requirements in patients undergoing mastectomy and axillary lymph node dissection
Detailed description
This study is a prospective, randomized, placebo-controlled, multicenter clinical trial designed to evaluate the analgesic efficacy of the serratus posterior superior intercostal plane (SPSIP) block in patients undergoing mastectomy with axillary lymph node dissection. Postoperative pain following breast surgery is often significant and may increase opioid consumption and related adverse effects, highlighting the need for effective regional anesthesia techniques.
The SPSIP block is a novel ultrasound-guided interfascial plane block with emerging evidence in thoracic and chest wall procedures; however, its role in breast surgery remains unclear, particularly in placebo-controlled settings. This study aims to determine whether the SPSIP block provides additional benefit as part of a standardized multimodal analgesia approach.
Participants will be randomly assigned to receive either SPSIP block with local anesthetic or a placebo intervention under identical conditions, with blinding applied to all relevant parties. All patients will receive the same perioperative anesthesia and analgesia protocol.
The results of this study are expected to clarify the clinical value of SPSIP block in breast surgery and contribute to the development of evidence-based postoperative pain management strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the SPSIP block group or the placebo group using a computer-generated randomization sequence. Both groups will receive identical perioperative management, and outcomes will be compared between parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Serratus Posterior Superior Intercostal Plane Block Group | Experimental | Procedure: SPSIP Block With BupivacaineParticipants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block prior to surgery using 30 mL of 0.25% bupivacaine, in addition to standard general anesthesia and multimodal analgesia. |
| Placebo Group | Placebo comparator | Procedure: SPSIP Block With SalineParticipants in this group will receive an ultrasound-guided placebo block using 30 mL of normal saline under identical conditions, in addition to standard general anesthesia and multimodal analgesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female patients aged 18-65 years
- ASA physical status I-III
- Scheduled for elective unilateral mastectomy with axillary lymph node dissection under general anesthesia
- Able to understand and use the Numeric Rating Scale (NRS) for pain assessment
- Provided written informed consent
Key exclusion criteria (9 listed)
- Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine)
- Coagulopathy, thrombocytopenia (<100,000/mm³), or ongoing anticoagulant/antiplatelet therapy that cannot be discontinued
- Infection or skin lesion at the injection site
- Planned bilateral surgery or additional major surgical procedures
- Chronic pain conditions or regular use of opioids, gabapentinoids, or centrally acting analgesics
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 |
|---|---|---|
| SPSIP Block With BupivacaineParticipants will receive an ultrasound-guided SPSIP block using bupivacaine. | Procedure or surgery | Serratus Posterior Superior Intercostal Plane Block Group |
| SPSIP Block With SalineParticipants will receive an ultrasound-guided SPSIP block using normal saline under identical conditions. | Procedure or surgery | Placebo Group |
Primary outcome
24-hour cumulative opioid consumption
Time frame: 24 hours
Total opioid consumption within the first 24 hours after surgery, recorded in milligrams.
7 secondary outcomes
Static postoperative pain intensity at rest
Time frame: 0, 1, 2, 6, 12, and 24 hours after surgery
Dynamic postoperative pain intensity during movement
Time frame: 0, 1, 2, 6, 12, and 24 hours after surgery
Rescue analgesia requirement
Time frame: Within 24 hours after surgery
Time to first rescue analgesia
Time frame: Within 24 hours after surgery
Incidence of postoperative nausea and vomiting (PONV)
Time frame: Within 24 hours after surgery
Quality of Recovery-15 (QoR-15) score
Time frame: 24 hours after surgery
Block-related and opioid-related adverse events
Time frame: Within 24 hours after surgery
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 1 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be shared.
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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.
Fatma Acil, M.D. principal investigator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPSIP Block With Bupivacaine and SPSIP Block With Saline in people with Breast Cancer, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital 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 5 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: looking for participants now, as of the sponsor's last update on 1 Sep 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. Some participants in this study may receive a placebo. 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?
Contact Fatma Acil, M.D. (+905337225225, acilfatma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour cumulative opioid consumption (time frame: 24 hours). 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 1 Sep 2026.