Erector Spinae Block Versus Paravertebral Block on Chronic Pain After Mastectomy

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)

Conditions

• Mastectomy; Lymphedema
• Chronic Pain
• Regional Anesthesia Morbidity
• Opioid Use

Interventions

DRUG

Paravertebral block

Thoracic paravertebral block is performed at the level of T4 or T5 if no axillary procedure is to be performed, and additionally at the level of T2 if axillary procedure is planned. A high-frequency transducer probe connected to an ultrasound (US) machine is positioned in a para-median sagittal plane, approximately 2-2.5 cm lateral to the spinous process at the ipsilateral side of surgery location to localize the transverse process and the paravertebral space. The skin is sterilized and the US probe covered with a sterile cap. A 22-gauge, 100 mm stimuplex nerve block needle is introduced in an in-plane direction. After perforating the costotransverse ligament and confirming negative aspiration of blood, 20ml of a mixture of ropivacaine 0.5% is injected. Anterior displacement of the pleura indicates appropriate spread of local anaesthesia (LA) in the paravertebral space.

DRUG

Erector Spinae block

The ESB is performed at the level of T4-T5 if no axillary procedure is to be performed, and additionally at the level of T2 (5ml) if axillary procedure is planned. A transducer probe is positioned in a para-median sagittal plane approximately 3 cm lateral to the spinous process at the ipsilateral side of surgery. Following the same sterilization procedure, the 10 cm stimuplex needle is introduced in an in-plane direction. The transverse process of the vertebrae, trapezius muscle, rhomboid major and erector spinae muscle are visualized, and 25 ml of ropivacaine 0.5% mixture is injected after confirming negative aspiration of blood (lower the concentration not to exceed 2 mg/kg ideal body weight). The LA spread lifts the erector spinae muscle off the bony shadow of the transverse process.

Sponsors & Collaborators

• American University of Beirut Medical Center

  lead OTHER

Principal Investigators

• Nancy Abou Nafeh, MD · American University of Beirut Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2028-05-01

Completion

2028-05-01

Countries

• Lebanon

Study Locations