Postoperative PainSPES-CPSPNCT07674836
SPSIP Block Versus ESP Block for Chronic Pain After Unilateral Breast Surgery
A study testing Serratus Posterior Superior Intercostal Plane Block and Ultrasound-guided Erector Spinae Plane Block in people with Postoperative Pain and Opioid Use, run by Engin Çetin at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, assessor-blinded study will compare serratus posterior superior intercostal plane block and erector spinae plane block in adult female patients undergoing unilateral breast surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Pain, Opioid Use
- What is being tested?
- Serratus Posterior Superior Intercostal Plane Block and Ultrasound-guided Erector Spinae 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 Jul 2026to 1 Dec 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
- Body mass index (BMI) between 18 and 35 kg/m²
- Scheduled for elective unilateral breast surgery (mastectomy with or without sentinel lymph node biopsy)
- Ability to understand and provide written informed consent
Who cannot join
- Infection at the site of block application
- Known allergy to local anesthetics
- Coagulopathy or anticoagulant therapy
- Chronic opioid use
- Pregnancy
- Inability to communicate or cooperate
Show all 10Show fewer
- Refusal to participate
- Failed block
- Requirement of additional intraoperative analgesia outside the study protocol
- Development of serious intraoperative complications
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
University of Health Sciences Kocaeli City Hospital
İzmit, Kocaeli, 41200
Engin Çetin, M.D, 05321206004 ext. 90, Doccetin52@gmail.com
About this study
Official title: Comparison of Serratus Posterior Superior Intercostal Plane Block and Erector Spinae Plane Block for the Prevention of Chronic Postoperative Pain After Unilateral Breast Surgery: A Prospective, Randomized, Assessor-Blinded Trial
This prospective, randomized, assessor-blinded study will compare serratus posterior superior intercostal plane block and erector spinae plane block in adult female patients undergoing unilateral breast surgery. The primary outcome is chronic postoperative pain at 3 months, assessed using the Brief Pain Inventory-Short Form.
Read the detailed description
This single-center, prospective, randomized, controlled, assessor-blinded study will include adult female patients scheduled for elective unilateral breast surgery. Participants will be randomized in a 1:1 ratio to receive either serratus posterior superior intercostal plane block or erector spinae plane block before general anesthesia.
The study aims to compare the effects of these two regional anesthesia techniques on chronic postoperative pain at 3 months. Chronic pain will be assessed using the Brief Pain Inventory-Short Form.
- Conditions
- Postoperative Pain, Opioid Use
- Being tested
- Serratus Posterior Superior Intercostal Plane Block, Ultrasound-guided Erector Spinae Plane Block
- Keywords
- Post Operative Pain, Opioid Use
- Medical subject headings
- Pain, Postoperative
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
Also called SPSIPB
An ultrasound-guided interfascial plane block performed between the serratus posterior superior muscle and the underlying ribs prior to general anesthesia.
Ultrasound-guided Erector Spinae Plane BlockProcedure or surgery
Also called ESPB
An ultrasound-guided erector spinae plane block performed prior to induction of general anesthesia using 30 mL of 0.25% bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| SPSIP Block | Active comparator | Participants will receive an ultrasound-guided serratus posterior superior intercostal plane block (SPSIPB) with 30 mL of 0.25% bupivacaine prior to induction of general anesthesia. Receives: Procedure: Serratus Posterior Superior Intercostal Plane Block |
| ESPB Block | Active comparator | Participants will receive an ultrasound-guided erector spinae plane block (ESPB) with 30 mL of 0.25% bupivacaine prior to induction of general anesthesia. Receives: Procedure: Ultrasound-guided Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Postoperative Pain Assessed by the Brief Pain Inventory-Short Form
Chronic postoperative pain will be assessed using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF assesses pain severity (worst, least, average, and current pain) and pain interference with daily activities. Pain severity items are scored on a 0-10 numeric rating scale (0 = no pain; 10 = pain as bad as you can imagine). Pain interference items are scored on a 0-10 numeric rating scale (0 = does not interfere; 10 = completely interferes). Higher scores indicate worse pain severity and greater pain-related interference.
Measured: Time Frame: T0: 3 months postoperatively
Secondary outcomes (1)
Neuropathic Pain Assessed by the DN4 Questionnaire
Neuropathic pain will be assessed using the Douleur Neuropathique 4 Questions (DN4) questionnaire. The DN4 consists of 10 items with a total score ranging from 0 to 10 (0 = no neuropathic pain characteristics; 10 = all neuropathic pain characteristics present). Higher scores indicate a greater likelihood of neuropathic pain. A total score of 4 or higher is considered indicative of neuropathic pain.
Measured: T0: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Jul 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to receive either serratus posterior superior intercostal plane block (SPSIPB) or erector spinae plane block (ESPB)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Engin Çetin
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Engin Çetin, Kocaeli City Hospital
- Investigators
- Engin Çetin, M.D, Principal investigator, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674836
- Sponsor's protocol ID
- KSH-ANREA-EC-07
- Acronym
- SPES-CPSP
- Status last verified
- Aug 2026
- First submitted
- 22 Jun 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Serratus Posterior Superior Intercostal Plane Block and Erector Spinae Plane Block for the Prevention of Chronic Postoperative Pain After Unilateral Breast Surgery: A Prospective, Randomized, Assessor-Blinded Trial
- ClinicalTrials.gov ID
- NCT07674836
- Acronym / sponsor ID
- SPES-CPSP / KSH-ANREA-EC-07
- Conditions
- Postoperative Pain, Opioid Use
- Keywords
- Post Operative Pain, Opioid Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Engin ÇetinOther government
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 30 Jun 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 prospective, randomized, assessor-blinded study will compare serratus posterior superior intercostal plane block and erector spinae plane block in adult female patients undergoing unilateral breast surgery. The primary outcome is chronic postoperative pain at 3 months, assessed using the Brief Pain Inventory-Short Form.
Detailed description
This single-center, prospective, randomized, controlled, assessor-blinded study will include adult female patients scheduled for elective unilateral breast surgery. Participants will be randomized in a 1:1 ratio to receive either serratus posterior superior intercostal plane block or erector spinae plane block before general anesthesia.
The study aims to compare the effects of these two regional anesthesia techniques on chronic postoperative pain at 3 months. Chronic pain will be assessed using the Brief Pain Inventory-Short Form.
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 randomized in a 1:1 ratio to receive either serratus posterior superior intercostal plane block (SPSIPB) or erector spinae plane block (ESPB)
| Arm | Type | Receives |
|---|---|---|
| SPSIP Block | Active comparator | Procedure: Serratus Posterior Superior Intercostal Plane BlockParticipants will receive an ultrasound-guided serratus posterior superior intercostal plane block (SPSIPB) with 30 mL of 0.25% bupivacaine prior to induction of general anesthesia. |
| ESPB Block | Active comparator | Procedure: Ultrasound-guided Erector Spinae Plane BlockParticipants will receive an ultrasound-guided erector spinae plane block (ESPB) with 30 mL of 0.25% bupivacaine prior to induction of general anesthesia. |
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
- Body mass index (BMI) between 18 and 35 kg/m²
- Scheduled for elective unilateral breast surgery (mastectomy with or without sentinel lymph node biopsy)
- Ability to understand and provide written informed consent
Key exclusion criteria (10 listed)
- Infection at the site of block application
- Known allergy to local anesthetics
- Coagulopathy or anticoagulant therapy
- Chronic opioid use
- Pregnancy
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 BlockAlso: SPSIPBAn ultrasound-guided interfascial plane block performed between the serratus posterior superior muscle and the underlying ribs prior to general anesthesia. | Procedure or surgery | SPSIP Block |
| Ultrasound-guided Erector Spinae Plane BlockAlso: ESPBAn ultrasound-guided erector spinae plane block performed prior to induction of general anesthesia using 30 mL of 0.25% bupivacaine. | Procedure or surgery | ESPB Block |
Primary outcome
Chronic Postoperative Pain Assessed by the Brief Pain Inventory-Short Form
Time frame: Time Frame: T0: 3 months postoperatively
Chronic postoperative pain will be assessed using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF assesses pain severity (worst, least, average, and current pain) and pain interference with daily activities. Pain severity items are scored on a 0-10 numeric rating scale (0 = no pain; 10 = pain as bad as you can imagine). Pain interference items are scored on a 0-10 numeric rating scale (0 = does not interfere; 10 = completely interferes). Higher scores indicate worse pain severity and greater pain-related interference.
1 secondary outcome
Neuropathic Pain Assessed by the DN4 Questionnaire
Time frame: T0: 3 months postoperatively
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 30 Sep 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.
Engin Çetin, M.D principal investigator
Kocaeli City 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 Serratus Posterior Superior Intercostal Plane Block and Ultrasound-guided Erector Spinae Plane Block in people with Postoperative Pain and Opioid Use, run by Engin Çetin 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 10 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 30 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. 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 Engin Çetin, M.D. (05321206004 ext. 90, Doccetin52@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Postoperative Pain Assessed by the Brief Pain Inventory-Short Form (time frame: Time Frame: T0: 3 months postoperatively). 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 30 Sep 2026.