Erector Spinae Block Versus Paravertebral Block on Chronic Pain After Mastectomy

NCT07561411 | Not Yet Recruiting

• 1 other identifier: BIO-2025-0326
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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)

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Chronic pain

  Chronic pain measured using NRS scale (0-10) 3 months after mastectomy

  3 months after mastectomy

Secondary Outcomes (5)

• Cumulative opioid consumption

  Amount of opioids used by the patient 48 hours after the procedure

• Pain score

  Pain score measured using NRS scale (0-10) on arrival to the PACU,12 hour, 24 hour,and 48 hour after the procedure

• Time needed for performing the block

  Time needed for performing the block (Perioperative)

• Complications

  Incidence of complications (Yes/No) (Perioperative)

• Anxiety or depression

  Anxiety or depression measured using the Hospital Anxiety and Depression Scale (HADS; range 0-42, with subscales 0-21 each), where higher scores indicate worse anxiety and depression, assessed 3 months after the procedure.

Study Arms (2)

Paravertebral block

ACTIVE COMPARATOR

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: Paravertebral block

Erector Spinae block

EXPERIMENTAL

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

Drug: Erector Spinae block

Interventions

Paravertebral block DRUG

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.

Also known as: TPVB

Paravertebral block

Erector Spinae block DRUG

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.

Also known as: ESPB

Erector Spinae block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

MeSH Terms

Conditions

Lymphedema; Chronic Pain

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nancy Abou Nafeh, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy Abou Nafeh, MD

CONTACT

01350000; na181@aub.edu.lb

Thouraya HajAli

CONTACT

th64@aub.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)