Erector Spinae Block Versus Paravertebral Block on Chronic Pain After Mastectomy (NCT07561411) | Clinical Trial Compass
RecruitingNot Applicable
Erector Spinae Block Versus Paravertebral Block on Chronic Pain After Mastectomy
Lebanon132 participantsStarted 2026-05-19
Plain-language summary
The goal of this clinical trial is to learn if the erector spinae block can reduce the incidence of chronic pain compared to the paravertebral block in adult patients undergoing total mastectomy. The study includes patients aged 18 to 80 years scheduled for mastectomy, with or without axillary dissection. The main questions it aims to answer are:
* Does erector spinae block reduce the incidence of chronic pain at 3 months after mastectomy compared to paravertebral block?
* Does erector spinae block affect postoperative outcomes such as opioid consumption at 48 hours, pain scores (in PACU, 24 and 48 hours), block performance time, and the incidence of complications, anxiety or depression, and pain intensity at 3 months?
Researchers will compare patients receiving erector spinae block to those receiving paravertebral block to determine if erector spinae block provides equivalent or improved outcomes in terms of chronic pain and perioperative measures.
Participants will:
* Be randomly assigned to receive either erector spinae block or paravertebral block prior to surgery
* Undergo total mastectomy (with or without axillary dissection)
* Have their pain assessed in the PACU and at 24 and 48 hours postoperatively
* Have opioid consumption measured during the first 48 hours after surgery
* Be followed up at 3 months to assess chronic pain, pain intensity, and psychological outcomes (anxiety or depression)
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
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:
* Adult patients between 18 and 80 years old.
* Scheduled to total mastectomy with or without axillary dissection
* Willing to receive regional anesthesia in addition to GA
* ASA classification 1-3
Exclusion Criteria:
* Previous thoracic surgery with an incision of \>2 cm
* Patient's refusal
* Allergy to local anesthetics
* Pregnant women
* Any contraindications to thoracic PVB, including intrathoracic infection, infection at the puncture site, cancer invasion of the puncture site, severe spinal deformity, history of spinal surgery, and severe coagulopathy; anticoagulants intake.
* American Society of Anesthesiologists (ASA) classification of 4 or higher,
* History of chronic pain or untreated clinical severe depression
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
Chronic pain
Timeframe: 3 months after mastectomy
Trial details
NCT IDNCT07561411
SponsorAmerican University of Beirut Medical Center