Comparison of ESP and SPSIP Blocks in Breast Surgery (NCT06611644) | Clinical Trial Compass
CompletedNot Applicable
Comparison of ESP and SPSIP Blocks in Breast Surgery
Turkey (Türkiye)75 participantsStarted 2024-07-06
Plain-language summary
This study aims to compare the efficacy of the ESP and SPSIP blocks in managing postoperative pain following breast surgery. Breast surgery, particularly after oncological and reconstructive procedures, often leads to significant postoperative pain. Effective pain control is crucial for accelerating recovery, reducing the risk of complications, and facilitating early discharge. Both ESP and SPSIP blocks involve the administration of local anesthetics into fascial plane spaces to achieve peripheral nerve blockade and control pain. This study will evaluate the effectiveness of these blocks in terms of pain scores, opioid consumption, and overall patient satisfaction to determine the optimal approach for postoperative pain management in breast surgery.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Age between 18 and 65 years.
* Scheduled for breast surgery (Modified Radical Mastectomy with or without axillary lymph node dissection, Mastopexy, Reduction Mammoplasty).
* Preoperative anesthesia risk classified as ASA I-III according to the American -Society of Anesthesiologists (ASA) classification.
* Patients who provide informed consent for participation in the study.
Exclusion Criteria
* History of coagulation disorders.
* Patients using aspirin or medically prescribed anticoagulants.
* Patients with severe systemic diseases (ASA IV).
* Patients undergoing emergency surgery.
* Patients younger than 18 or older than 65 years.
* Patients who do not develop adequate sensory block after the procedure.
* Presence of infection at the block site.
* Patients with thoracic deformities.
* Patients who decline to participate in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative Opioid Consumption
Timeframe: 24 hours
2
Numeric Rating Scale (NRS)
Timeframe: 24 hours postoperatively (measured at 0, 2, 6, 12, and 24 hours)