Postoperative Acute PainNCT07246720
IPP-PSP Block vs. SPSIPB in Breast Surgery
A study testing Interpectoral-Pectoserratus Plane Block and Serratus Posterior Superior Intercostal Plane Block in people with Postoperative Acute Pain and Breast Cancer, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized clinical study aims to compare the analgesic efficacy of the interpectoral-pectoserratus plane block and the serratus posterior superior intercostal plane block for postoperative pain management in patients undergoing breast cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Acute Pain, Breast Cancer, Regional Anesthesia
- What is being tested?
- Interpectoral-Pectoserratus Plane Block and Serratus Posterior Superior Intercostal Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2025to 30 Jun 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
- 18-65 years of age
- ASA I-II-III risk groups
- Patients with informed consent
- Patients undergoing breast cancer surgery
Who cannot join
- ASA ≥ IV
- History of allergy to local anesthetics
- Known coagulation disorders
- Infection near the insertion site
- Chronic analgesic use
- Patients with diabetes mellitus and those receiving neoadjuvant chemotherapy (due to potential impairment of pain sensation)
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- Body mass index >30
- Dementia or confusion
- Lack of cooperation
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
Zonguladk Bulent ecevit University
Zonguldak, Kozlu, 67600
Hande aydemir, prof.dr, +90 372 261 23 00, hande.aydemir@beun.edu.tr
About this study
Official title: Interpectoral-pectoserratus Plane Block vs. Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Patients Undergoing Breast Cancer Surgery
This prospective, randomized clinical study aims to compare the analgesic efficacy of the interpectoral-pectoserratus plane block and the serratus posterior superior intercostal plane block for postoperative pain management in patients undergoing breast cancer surgery. Both techniques are ultrasound-guided regional anesthesia methods targeting different interfascial planes of the thoracic wall. The study will evaluate postoperative pain scores, opioid consumption, Quality of recovery and potential complications. The findings are expected to contribute to optimizing regional anesthesia strategies for enhanced recovery and improved analgesia following breast cancer surgery.
- Conditions
- Postoperative Acute Pain, Breast Cancer, Regional Anesthesia
- Being tested
- Interpectoral-Pectoserratus Plane Block, Serratus Posterior Superior Intercostal Plane Block
- Keywords
- Interpectoral-Pectoserratus Plane Block, Serratus Posterior Superior Intercostal Plane Block, Breast Cancer Surgery, Opioid Consumption, Pain Management
- Medical subject headings
- Pain, Postoperative, Breast Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpectoral-Pectoserratus Plane BlockProcedure or surgery
Ultrasound-guided injection between pectoralis major-minor and pectoralis minor-serratus anterior planes.
Serratus Posterior Superior Intercostal Plane BlockProcedure or surgery
Ultrasound-guided injection between the serratus posterior superior muscle and the intercostal muscles.
| Study group | Role | What they receive |
|---|---|---|
| Group IPP-PSP | Active comparator | Interpectoral-Pectoserratus Plane Block Receives: Procedure: Interpectoral-Pectoserratus Plane Block |
| Group SPSIPB | Active comparator | Serratus Posterior Superior Intercostal Plane Block 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.
Cumulative opioid consumption
Cumulative opioid consumption in the first 24 postoperative hours after the completion of the surgical procedure
Measured: in the first 24 hours after completion of the surgical procedure
Secondary outcomes (2)
Postsurgical Quality of Recovery measured by the Quality of Recovery questionnaire
Postsurgical recovery by Quality of Recovery questionnaire (QoR-15) on first (D1) day after surgery.
The minimum score on the Quality of Recovery questionnaire is 0 and the maximum score 150. Higher scores mean better quality of recovery.
Measured: first day after surgery
Number of episodes of postoperative pain
Number of episodes of postoperative pain (NRS score ≥ 4) at rest and at deep inspiration in the first 24 postoperative hours after the completion of the surgical procedure
Measured: In the first 24 hours after completion of the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start15 Nov 2025 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Acute 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağdaş Baytar, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246720
- Sponsor's protocol ID
- 2025/16-9
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interpectoral-pectoserratus Plane Block vs. Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Patients Undergoing Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT07246720
- Acronym / sponsor ID
- 2025/16-9
- Conditions
- Postoperative Acute Pain, Breast Cancer, Regional Anesthesia
- Keywords
- Interpectoral-Pectoserratus Plane Block, Serratus Posterior Superior Intercostal Plane Block, Breast Cancer Surgery, Opioid Consumption, Pain Management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 15 Nov 2025 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 24 Nov 2025 (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 clinical study aims to compare the analgesic efficacy of the interpectoral-pectoserratus plane block and the serratus posterior superior intercostal plane block for postoperative pain management in patients undergoing breast cancer surgery. Both techniques are ultrasound-guided regional anesthesia methods targeting different interfascial planes of the thoracic wall. The study will evaluate postoperative pain scores, opioid consumption, Quality of recovery and potential complications. The findings are expected to contribute to optimizing regional anesthesia strategies for enhanced recovery and improved analgesia following breast cancer surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group IPP-PSP | Active comparator | Procedure: Interpectoral-Pectoserratus Plane BlockInterpectoral-Pectoserratus Plane Block |
| Group SPSIPB | Active comparator | Procedure: Serratus Posterior Superior Intercostal Plane BlockSerratus Posterior Superior Intercostal Plane Block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years of age
- ASA I-II-III risk groups
- Patients with informed consent
- Patients undergoing breast cancer surgery
Key exclusion criteria (9 listed)
- ASA ≥ IV
- History of allergy to local anesthetics
- Known coagulation disorders
- Infection near the insertion site
- Chronic analgesic 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 |
|---|---|---|
| Interpectoral-Pectoserratus Plane BlockUltrasound-guided injection between pectoralis major-minor and pectoralis minor-serratus anterior planes. | Procedure or surgery | Group IPP-PSP |
| Serratus Posterior Superior Intercostal Plane BlockUltrasound-guided injection between the serratus posterior superior muscle and the intercostal muscles. | Procedure or surgery | Group SPSIPB |
Primary outcome
Cumulative opioid consumption
Time frame: in the first 24 hours after completion of the surgical procedure
Cumulative opioid consumption in the first 24 postoperative hours after the completion of the surgical procedure
2 secondary outcomes
Postsurgical Quality of Recovery measured by the Quality of Recovery questionnaire
Time frame: first day after surgery
Number of episodes of postoperative pain
Time frame: In the first 24 hours after completion of the surgical procedure
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 24 Nov 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpectoral-Pectoserratus Plane Block and Serratus Posterior Superior Intercostal Plane Block in people with Postoperative Acute Pain and Breast Cancer, run by Zonguldak Bulent Ecevit University 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 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: opening soon, as of the sponsor's last update on 24 Nov 2025. 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 çağdaş baytar, MD (+905542255960, cagdasbaytar31@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative opioid consumption (time frame: in the first 24 hours after completion of the surgical procedure). 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 24 Nov 2025.