Effect of Continuous Erector Spinae Plane Block With Ropivacaine on Postoperative Pain and NF-κB … (NCT07562945) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Continuous Erector Spinae Plane Block With Ropivacaine on Postoperative Pain and NF-κB Levels After Mastectomy
Indonesia40 participantsStarted 2026-05-01
Plain-language summary
This study aims to evaluate the effect of continuous erector spinae plane block (CESPB) using ropivacaine on postoperative pain in patients undergoing elective mastectomy. In addition to pain control, this study investigates the impact of CESPB on systemic inflammatory response as measured by nuclear factor kappa B (NF-κB) levels, opioid consumption, and quality of recovery. Patients will be randomly assigned to receive CESPB or standard analgesia without block. Outcomes will be assessed within the first 24 hours after surgery. The findings are expected to provide evidence on the clinical and biological benefits of CESPB as part of multimodal analgesia in breast surgery.
Who can participate
Age range
30 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:
* Female patients aged 18 to 65 years
* Diagnosed with breast cancer
* Scheduled for elective mastectomy under general anesthesia
* American Society of Anesthesiologists (ASA) physical status I-III
* Able to understand and provide written informed consent
* Body mass index (BMI) 18-29 kg/m²
Exclusion Criteria:
* Contraindications to regional anesthesia
* Contraindications or allergy to ropivacaine or local anesthetics
* Inability to use a visual analog scale (VAS) for pain assessment
* Inability to understand or operate patient-controlled analgesia (PCA)
* History of chronic pain or ongoing infection requiring treatment
* History of chronic analgesic use
* History of autoimmune disease
* Uncontrolled systemic disease
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.