Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID07561411

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

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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.
Not Eligible

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

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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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