Post Operative PainNCT07541040
Serratus vs ESP Block for Postoperative Pain in Unilateral Breast Surgery
A study testing Serratus Posterior Superior Intercostal Plane Block in people with Post Operative Pain and Opioid Use, run by Engin Çetin at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, assessor-blinded trial compares serratus posterior superior intercostal plane block (SPSIPB) and erector spinae plane block (ESPB) for postoperative analgesia in unilateral breast surgery. 54 patients will be randomized to receive either SPSIPB or ESPB before general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Post Operative Pain, Opioid Use
- What is being tested?
- Serratus Posterior Superior Intercostal Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 1 Nov 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, 532 120 60 04 ext. 90, Doccetin52@gmail.com
About this study
Official title: Comparison of Serratus Posterior Superior Intercostal Plane Block and Erector Spinae Plane Block for Postoperative Analgesia in Unilateral Breast Surgery: A Prospective, Randomized, Assessor-Blinded Trial
This prospective, randomized, assessor-blinded trial compares serratus posterior superior intercostal plane block (SPSIPB) and erector spinae plane block (ESPB) for postoperative analgesia in unilateral breast surgery. 54 patients will be randomized to receive either SPSIPB or ESPB before general anesthesia.
The primary outcome is postoperative pain scores within the first 24 hours. The secondary outcome is opioid consumption.
Read the detailed description
This prospective, randomized, assessor-blinded, single-center clinical trial is designed to compare the effects of serratus posterior superior intercostal plane block (SPSIPB) and erector spinae plane block (ESPB) on postoperative analgesia in patients undergoing unilateral breast surgery. Eligible adult female patients will be randomly assigned in a 1:1 ratio to receive either SPSIPB or ESPB under ultrasound guidance prior to induction of general anesthesia.
All patients will receive standardized general anesthesia and postoperative multimodal analgesia. Postoperative pain will be assessed using the Numerical Rating Scale (NRS) at predefined time points within the first 24 hours, both at rest and during movement. The primary outcome is postoperative pain scores within 24 hours. The secondary outcome is total opioid consumption during the same period.
This study aims to determine whether SPSIPB provides comparable or superior analgesia compared to ESPB in unilateral breast surgery.
- Conditions
- Post Operative Pain, Opioid Use
- Being tested
- Serratus Posterior Superior Intercostal 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.
| 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: Serratus Posterior Superior Intercostal Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Scores (NRS)
Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS; 0-10, where 0 indicates no pain and 10 indicates worst imaginable pain). Pain scores will be evaluated both at rest and during movement (coughing)
Measured: T0: upon arrival at recovery (Aldrete ≥9), T1: 1 hour, T2: 4 hours, T3: 8 hours, T4: 12 hours, T5: 24 hours postoperatively
Secondary outcomes (1)
Total Opioid Consumption
Total opioid consumption will be recorded during the first 24 hours postoperatively and expressed as intravenous tramadol consumption.
Measured: T0-T1: 0-1 hour, T1-T2: 1-4 hours, T2-T3: 4-8 hours, T3-T4: 8-12 hours, and T4-T5: 12-24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start1 May 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative 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
- 54 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
- NCT07541040
- Sponsor's protocol ID
- KSH-ANREA-EC-05
- Status last verified
- Aug 2026
- First submitted
- 15 Apr 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arik E, Zengin M, Seker G, Kucuk O, Gungordu E, Ozguner Y, Alagoz A, Ergil J. Is the serratus posterior superior intercostal plane block a viable alternative to the erector spinae plane block for postoperative analgesia in breast surgery? A prospective, randomized trial. BMC Anesthesiol. 2025 Nov 29;26(1):11. doi: 10.1186/s12871-025-03531-y.
PubMed 41318393
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 Postoperative Analgesia in Unilateral Breast Surgery: A Prospective, Randomized, Assessor-Blinded Trial
- ClinicalTrials.gov ID
- NCT07541040
- Acronym / sponsor ID
- KSH-ANREA-EC-05
- Conditions
- Post Operative Pain, Opioid Use
- Keywords
- Post Operative Pain, Opioid Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Engin ÇetinOther government
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 21 Apr 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 trial compares serratus posterior superior intercostal plane block (SPSIPB) and erector spinae plane block (ESPB) for postoperative analgesia in unilateral breast surgery. 54 patients will be randomized to receive either SPSIPB or ESPB before general anesthesia.
The primary outcome is postoperative pain scores within the first 24 hours. The secondary outcome is opioid consumption.
Detailed description
This prospective, randomized, assessor-blinded, single-center clinical trial is designed to compare the effects of serratus posterior superior intercostal plane block (SPSIPB) and erector spinae plane block (ESPB) on postoperative analgesia in patients undergoing unilateral breast surgery. Eligible adult female patients will be randomly assigned in a 1:1 ratio to receive either SPSIPB or ESPB under ultrasound guidance prior to induction of general anesthesia.
All patients will receive standardized general anesthesia and postoperative multimodal analgesia. Postoperative pain will be assessed using the Numerical Rating Scale (NRS) at predefined time points within the first 24 hours, both at rest and during movement. The primary outcome is postoperative pain scores within 24 hours. The secondary outcome is total opioid consumption during the same period.
This study aims to determine whether SPSIPB provides comparable or superior analgesia compared to ESPB in unilateral breast surgery.
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: Serratus Posterior Superior Intercostal 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 | ESPB Block, SPSIP Block |
Primary outcome
Postoperative Pain Scores (NRS)
Time frame: T0: upon arrival at recovery (Aldrete ≥9), T1: 1 hour, T2: 4 hours, T3: 8 hours, T4: 12 hours, T5: 24 hours postoperatively
Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS; 0-10, where 0 indicates no pain and 10 indicates worst imaginable pain). Pain scores will be evaluated both at rest and during movement (coughing)
1 secondary outcome
Total Opioid Consumption
Time frame: T0-T1: 0-1 hour, T1-T2: 1-4 hours, T2-T3: 4-8 hours, T3-T4: 8-12 hours, and T4-T5: 12-24 hours 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.
- Background: PubMed 41318393Arik E, Zengin M, Seker G, Kucuk O, Gungordu E, Ozguner Y, Alagoz A, Ergil J. Is the serratus posterior superior intercostal plane block a viable alternative to the erector spinae plane block for postoperative analgesia in breast surgery? A prospective, randomized trial. BMC Anesthesiol. 2025 Nov 29;26(1):11. doi: 10.1186/s12871-025-03531-y.
- Individual participant dataSharing planned: No
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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 in people with Post Operative 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. (5321206004 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?
Postoperative Pain Scores (NRS) (time frame: T0: upon arrival at recovery (Aldrete ≥9), T1: 1 hour, T2: 4 hours, T3: 8 hours, T4: 12 hours, T5: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07541040, which also lists 1 linked publication.
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.