Serratus Posterior Superior Intercostal Plane Block (SPSIPB)SPSIP-TLR4NCT07843212
Effects of SPSIP Block on Perioperative Inflammation and TLR4 in Breast Cancer Surgery
A study testing Serratus posterior superior intercostal plane block in people with Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Breast Cancer, run by Mucahide Emine Fidancı Kuas at 1 site in Turkey (Türkiye).
Trial summary
This study will investigate whether the serratus posterior superior intercostal plane (SPSIP) block improves postoperative recovery after breast cancer surgery. Participants will be randomly assigned to one of two groups. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Breast Cancer, Toll-Like Receptors
- What is being tested?
- Serratus posterior superior intercostal plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jun 2026to 30 Jan 2027
- 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 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female patients aged 18 to 85 years.
- Scheduled for elective breast cancer surgery under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Able to provide written informed consent.
Who cannot join
- Refusal to participate or inability to provide informed consent.
- Allergy or contraindication to the study local anesthetic.
- Coagulopathy or ongoing anticoagulant treatment contraindicating regional anesthesia.
- Infection at the planned injection site.
- Pre-existing chronic pain condition or regular opioid use.
- Inability to communicate pain scores or comply with study assessments.
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
Hitit University Erol Olçok Training and Research Hospital
Çorum, Çorum, 19040
Mucahide Emine Fidancı Kuas, MD, +90-553-205-9918, efidanci02@gmail.com
About this study
Official title: Effects of Serratus Posterior Superior Intercostal Plane Block on Perioperative Inflammatory Response and TLR4-Mediated Innate Immune Activation in Breast Cancer Surgery: A Prospective, Randomized, Double-Blind, Sham-Controlled Trial
This study will investigate whether the serratus posterior superior intercostal plane (SPSIP) block improves postoperative recovery after breast cancer surgery.
Participants will be randomly assigned to one of two groups. One group will receive an ultrasound-guided SPSIP block, while the other group will undergo a similar procedure without active medication (sham procedure). Both groups will receive standard general anesthesia and postoperative pain management.
Read more
Postoperative pain intensity, need for additional pain medication, nausea and vomiting, length of hospital stay, and persistent pain at 3 months after surgery will be assessed. Blood samples collected before surgery and at predetermined postoperative time points will be used to evaluate the body's inflammatory response to surgery and innate immune system activity. These assessments will include toll-like receptor 4 (TLR4), an immune-system marker, and selected inflammatory markers.
The main question of this study is whether the SPSIP block, compared with the sham procedure, reduces the surgery-related inflammatory response and improves postoperative pain outcomes.
- Conditions
- Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Breast Cancer, Toll-Like Receptors
- Being tested
- Serratus posterior superior intercostal plane block, Sham SPSIP Procedure
- Keywords
- serratus posterior superior intercostal plane block, SPSIP block, postoperative pain, inflammatory response, Toll-like receptor 4, breast surgery
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative, Macular Degeneration, Age-Related, 10
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
The SPSIP block will be performed preoperatively in the sitting position under ultrasound guidance using a linear 6-13 MHz transducer and an in-plane needle approach. Local anesthetic will be injected into the serratus posterior superior intercostal plane according to the study protocol.
Sham SPSIP ProcedureProcedure or surgery
A simulated ultrasound-guided SPSIP procedure will be performed in the sitting position using the same positioning and ultrasound preparation as the SPSIP block group, but no local anesthetic will be injected.
| Study group | Role | What they receive |
|---|---|---|
| SPSIP Block Group | Experimental | Participants will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block with local anesthetic before induction of general anesthesia, in addition to standardized general anesthesia and postoperative analgesia. Receives: Procedure: Serratus posterior superior intercostal plane block |
| Sham Block Group | Sham comparator | Participants will undergo a simulated ultrasound-guided SPSIP procedure without local anesthetic injection before induction of general anesthesia, in addition to standardized general anesthesia and postoperative analgesia. Receives: Procedure: Sham SPSIP Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum TLR4 concentration from baseline to 24 hours after surgery
Serum Toll-like receptor 4 (TLR4) concentration will be measured by ELISA before the intervention (baseline, T0) and 24 hours after surgery (T3). The primary outcome is the change in TLR4 concentration between T0 and T3, compared between the SPSIP block and sham-control groups.
Measured: Baseline (preoperative) to 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 posted25 Sep 2026
- Study start22 Jun 2026
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serratus Posterior Superior Intercostal Plane Block (SPSIPB)Studies 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
- Supportive care
- 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 sham block group. Both groups will receive standardized general anesthesia and postoperative analgesia.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mucahide Emine Fidancı Kuas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mucahide Emine Fidancı Kuas, Erol Olcok Corum Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843212
- Sponsor's protocol ID
- 2026-31
- Other IDs
- M.D. HULYA TOPCU
- Acronym
- SPSIP-TLR4
- Status last verified
- Oct 2026
- First submitted
- 20 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Serratus Posterior Superior Intercostal Plane Block on Perioperative Inflammatory Response and TLR4-Mediated Innate Immune Activation in Breast Cancer Surgery: A Prospective, Randomized, Double-Blind, Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT07843212
- Acronym / sponsor ID
- SPSIP-TLR4 / 2026-31
- Conditions
- Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Breast Cancer, Toll-Like Receptors
- Keywords
- serratus posterior superior intercostal plane block, SPSIP block, postoperative pain, inflammatory response, Toll-like receptor 4, breast surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mucahide Emine Fidancı KuasUniversity, hospital or other
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 25 Sep 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 will investigate whether the serratus posterior superior intercostal plane (SPSIP) block improves postoperative recovery after breast cancer surgery.
Participants will be randomly assigned to one of two groups. One group will receive an ultrasound-guided SPSIP block, while the other group will undergo a similar procedure without active medication (sham procedure). Both groups will receive standard general anesthesia and postoperative pain management.
Postoperative pain intensity, need for additional pain medication, nausea and vomiting, length of hospital stay, and persistent pain at 3 months after surgery will be assessed. Blood samples collected before surgery and at predetermined postoperative time points will be used to evaluate the body's inflammatory response to surgery and innate immune system activity. These assessments will include toll-like receptor 4 (TLR4), an immune-system marker, and selected inflammatory markers.
The main question of this study is whether the SPSIP block, compared with the sham procedure, reduces the surgery-related inflammatory response and improves postoperative pain outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, 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 sham block group. Both groups will receive standardized general anesthesia and postoperative analgesia.
| Arm | Type | Receives |
|---|---|---|
| SPSIP Block Group | Experimental | Procedure: Serratus posterior superior intercostal plane blockParticipants will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block with local anesthetic before induction of general anesthesia, in addition to standardized general anesthesia and postoperative analgesia. |
| Sham Block Group | Sham comparator | Procedure: Sham SPSIP ProcedureParticipants will undergo a simulated ultrasound-guided SPSIP procedure without local anesthetic injection before induction of general anesthesia, in addition to standardized general anesthesia and postoperative analgesia. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients aged 18 to 85 years.
- Scheduled for elective breast cancer surgery under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Able to provide written informed consent.
Key exclusion criteria (6 listed)
- Refusal to participate or inability to provide informed consent.
- Allergy or contraindication to the study local anesthetic.
- Coagulopathy or ongoing anticoagulant treatment contraindicating regional anesthesia.
- Infection at the planned injection site.
- Pre-existing chronic pain condition or regular opioid use.
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 blockThe SPSIP block will be performed preoperatively in the sitting position under ultrasound guidance using a linear 6-13 MHz transducer and an in-plane needle approach. Local anesthetic will be injected into the serratus posterior superior intercostal plane according to the study protocol. | Procedure or surgery | SPSIP Block Group |
| Sham SPSIP ProcedureA simulated ultrasound-guided SPSIP procedure will be performed in the sitting position using the same positioning and ultrasound preparation as the SPSIP block group, but no local anesthetic will be injected. | Procedure or surgery | Sham Block Group |
Primary outcome
Change in serum TLR4 concentration from baseline to 24 hours after surgery
Time frame: Baseline (preoperative) to 24 hours after surgery
Serum Toll-like receptor 4 (TLR4) concentration will be measured by ELISA before the intervention (baseline, T0) and 24 hours after surgery (T3). The primary outcome is the change in TLR4 concentration between T0 and T3, compared between the SPSIP block and sham-control groups.
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 21 Oct 2026.
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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.
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 in people with Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Breast Cancer, run by Mucahide Emine Fidancı Kuas 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 6 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 21 Oct 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 Mucahide Emine Fidancı Kuas, MD (+90-553-204-9918, efidanci02@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum TLR4 concentration from baseline to 24 hours after surgery (time frame: Baseline (preoperative) to 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 21 Oct 2026.