- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07246720
IPP-PSP Block vs. SPSIPB in Breast Surgery
November 17, 2025 updated by: Çağdaş Baytar, Zonguldak Bulent Ecevit University
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.
Study Overview
Status
Not yet recruiting
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: çağdaş baytar, MD
- Phone Number: +905542255960
- Email: cagdasbaytar31@gmail.com
Study Locations
-
-
Kozlu
-
Zonguldak, Kozlu, Turkey (Türkiye), 67600
- Zonguladk Bulent ecevit University
-
Contact:
- Hande aydemir, prof.dr
- Phone Number: +90 372 261 23 00
- Email: hande.aydemir@beun.edu.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 18-65 years of age
- ASA I-II-III risk groups
- Patients with informed consent
- Patients undergoing breast cancer surgery
Exclusion Criteria: • Ages <18 and >65
- 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)
- Body mass index >30
- Dementia or confusion
- Lack of cooperation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group IPP-PSP
Interpectoral-Pectoserratus Plane Block
|
Ultrasound-guided injection between pectoralis major-minor and pectoralis minor-serratus anterior planes.
|
|
Active Comparator: Group SPSIPB
Serratus Posterior Superior Intercostal Plane Block
|
Ultrasound-guided injection between the serratus posterior superior muscle and the intercostal muscles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
in the first 24 hours after completion of the surgical procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postsurgical Quality of Recovery measured by the Quality of Recovery questionnaire
Time Frame: first day after surgery
|
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. |
first day after surgery
|
|
Number of episodes of postoperative pain
Time Frame: In the first 24 hours after completion of the surgical procedure
|
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
|
In the first 24 hours after completion of the surgical procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 15, 2025
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
November 17, 2025
First Submitted That Met QC Criteria
November 17, 2025
First Posted (Actual)
November 24, 2025
Study Record Updates
Last Update Posted (Actual)
November 24, 2025
Last Update Submitted That Met QC Criteria
November 17, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Nervous System Diseases
- Postoperative Complications
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Neurobehavioral Manifestations
- Skin Diseases
- Breast Diseases
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Skin and Connective Tissue Diseases
- Signs and Symptoms
- Pain, Postoperative
- Breast Neoplasms
- Agnosia
Other Study ID Numbers
- 2025/16-9
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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