Actively Recruiting
The Effect of Erector Spinae Block Versus Paravertebral Block on the Incidence of Chronic Pain After Mastectomy: A Randomized Controlled Trial
Led by American University of Beirut Medical Center · Updated on 2026-06-02
132
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the erector spinae block (ESB) compared to the paravertebral block (PVB) to see if ESB can reduce the occurrence of chronic pain three months after total mastectomy in adults aged 18 to 80 years. This study aims to determine whether ESB provides equivalent or improved outcomes in chronic pain and other postoperative measures such as opioid use, pain scores, and psychological effects like anxiety or depression. The trial is a prospective randomized clinical study conducted at a medical center. Participants will be randomly assigned to receive either the erector spinae block or the paravertebral block before undergoing total mastectomy, with or without axillary dissection. The paravertebral block is performed using ultrasound guidance to inject ropivacaine near the spinal nerves at specific thoracic levels. The erector spinae block involves injecting ropivacaine at similar thoracic levels but targets a different muscle area, also under ultrasound guidance. Both procedures use carefully measured doses of local anesthetic. During the study, participants will have their pain levels assessed immediately after surgery in the recovery area and at 24 and 48 hours postoperatively. Opioid consumption will be recorded for the first 48 hours after surgery. Researchers will also measure the time needed to perform each block, monitor for complications, and evaluate anxiety or depression along with pain intensity at three months after surgery. The main outcome is the incidence of chronic pain at three months following mastectomy.
CONDITIONS
Brief Title
Erector Spinae Block Versus Paravertebral Block on Chronic Pain After Mastectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 general anesthesia.
- ASA classification 1 to 3.
You will not qualify if you...
- Previous thoracic surgery with an incision larger than 2 cm.
- Patient refusal to participate.
- Allergy to local anesthetics.
- Pregnant women.
- Contraindications to thoracic paravertebral block, including intrathoracic infection, infection at the puncture site, cancer invasion at the puncture site, severe spinal deformity, history of spinal surgery, severe coagulopathy, or anticoagulant use.
- ASA classification of 4 or higher.
- History of chronic pain or untreated severe clinical depression.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Perioperative period
Participants receive either an erector spinae block or a paravertebral block as regional anesthesia during mastectomy surgery to help reduce acute and chronic post-surgical pain.
1 visit (in-person) on the day of surgery
Duration - 3 months
Participants are monitored for pain levels, opioid consumption, complications, and anxiety or depression up to 3 months after surgery to assess the incidence of chronic pain.
4 visits (in-person or remote) including assessments at 48 hours, and 3 months post surgery
Trial Site Locations
Total: 1 location
1
American University of Beirut Medical Center
Beirut, Lebanon
Actively Recruiting
Research Team
N
Nancy Abou Nafeh, MD
T
Thouraya HajAli
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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