NCT07561411 Erector Spinae Block Versus Paravertebral Block on Chronic Pain After Mastectomy
| NCT ID | NCT07561411 |
| Status | Recruiting |
| Phase | — |
| Sponsor | American University of Beirut Medical Center |
| Condition | Mastectomy; Lymphedema |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2026-05-19 |
| Primary Completion | 2028-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 132 participants in total. It began in 2026-05-19 with a primary completion date of 2028-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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)
Eligibility Criteria
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
Contact & Investigator
Nancy Abou Nafeh, MD
PRINCIPAL INVESTIGATOR
American University of Beirut Medical Center
Frequently Asked Questions
Who can join the NCT07561411 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Mastectomy; Lymphedema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07561411 currently recruiting?
Yes, NCT07561411 is actively recruiting participants. Contact the research team at na181@aub.edu.lb for enrollment information.
Where is the NCT07561411 trial being conducted?
This trial is being conducted at Beirut, Lebanon.
Who is sponsoring the NCT07561411 clinical trial?
NCT07561411 is sponsored by American University of Beirut Medical Center. The principal investigator is Nancy Abou Nafeh, MD at American University of Beirut Medical Center. The trial plans to enroll 132 participants.