ClinicalTrials.gg
RecruitingNCT07843212SPSIP-TLR4Updated Oct 21, 2026

Effects of SPSIP Block on Perioperative Inflammation and TLR4 in Breast Cancer Surgery

An interventional study of Serratus posterior superior intercostal plane block and Sham SPSIP Procedure in Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Breast Cancer and Toll-Like Receptors, sponsored by Mucahide Emine Fidancı Kuas. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Mucahide Emine Fidancı Kuas · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Updated Oct 21, 2026Primary outcomes revisedStart date moved+2 moreGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 396 studies in Breast Neoplasms with a site in Turkey — 81 open to participants now, 127 under way, 46 of them phase 3. Breast Neoplasms · Turkey.

Planned enrollment
184th of 318
80 · median 103
Started
2026
with 37 others
No phase
181 of 396
47 open now
Primary completion
2027-01
later than 80 of 126 live
Registered
392nd of 396
by date

Among the 396 studies in Breast Neoplasms with a site in Turkey, this one is the 184th largest by planned enrollment of the 318 interventional ones that give a count, is one of 38 that started in 2026, is one of 181 with no phase, reaches primary completion later than 80 of the 126 other live ones, and was the 392nd registered.

Breast Neoplasms

14,829 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.

Browse Breast Neoplasms studies →

Open to participants now

81 of the 396 studies in Breast Neoplasms with a site in Turkey are open now. Recruiting first, the newest first:

75 more — sign in →

All 81 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.

This study: 18 Years to 85 Years · female · healthy volunteers too.

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02

Study 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. 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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female patients aged 18 to 85 years.
  • Scheduled for elective breast cancer surgery under general anesthesia.
  • (ASA) physical status I-III.
  • Able to provide written .

Exclusion criteria

Exclusion Criteria:

  • Refusal to participate or inability to provide .
  • Allergy or 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    SPSIP Block Group

    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.

    Procedure: Serratus posterior superior intercostal plane block

  • Sham comparator
    Sham Block Group

    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.

    Procedure: Sham SPSIP Procedure

Interventions

  • ProcedureSerratus posterior superior intercostal plane block

    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.

  • ProcedureSham SPSIP Procedure

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (preoperative) to 24 hours after surgery

07

Study locations

1 of 1 sites recruiting
08

Timeline

4 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Jan 2027, 7 months after the start.

Of 2,663 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 7 months is below that.

Counting every sponsor, half of 2,773 studies reached it within 33 months; a quarter within 15 and three quarters within 66.

Start moved once since we started tracking on Sep 25, 2026: Jul 2026 → Jun 2026, on Oct 16, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2026
First posted
Sep 25, 2026
StartActual
Jun 22, 2026was Jul 2026
Primary completionEst.
Jan 30, 2027
CompletionEst.
Jan 30, 2027
Last update
Oct 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Jul 14, 2026→Jun 22, 2026
Oct 16, 2026
Primary outcomes
1 description edited
What changed in the outcomes
  • DescriptionChange in serum TLR4 concentration from baseline to 24 hours after surgery: how it is measured was reworded
Oct 21, 2026
Title
EFFECTS OFEffects of SPSIP BLOCK ON PERIOPERATİVE INFLAMMATION ANDBlock on Perioperative Inflammation and TLR4 IN BREAST CANCER SURGERYin Breast Cancer Surgery
Oct 9, 2026
Registered
First appeared on the registry
Sep 25, 2026
Show all 4 updates
  1. Oct 21, 2026
    Primary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionChange in serum TLR4 concentration from baseline to 24 hours after surgery: how it is measured was reworded
  2. Oct 16, 2026
    Start date Jul 14, 2026→Jun 22, 2026
  3. Oct 9, 2026
    Title EFFECTS OFEffects of SPSIP BLOCK ON PERIOPERATİVE INFLAMMATION ANDBlock on Perioperative Inflammation and TLR4 IN BREAST CANCER SURGERYin Breast Cancer Surgery
    + 2 other changes: verification date and responsible party
  4. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07843212
Lead sponsor
Mucahide Emine Fidancı Kuas
Responsible party
Mucahide Emine Fidancı Kuas (Resident Physician, Department of Anesthesiology and Reanimation, Erol Olcok Corum Training and Research Hospital) — Sponsor-investigator
First posted
Sep 25, 2026
Start date
Jun 22, 2026
Primary completion
Jan 30, 2027 (estimated)
Completion
Jan 30, 2027 (estimated)
Last update
Oct 21, 2026

Study contacts

Mucahide Emine Fidancı Kuas, MD
Contact
efidanci02@gmail.com
+90-553-204-9918

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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