Health Trials

Erector Spinae Block Versus Paravertebral Block on Chronic Pain After Mastectomy

ConditionsMastectomy; LymphedemaChronic PainRegional Anesthesia MorbidityOpioid Use
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAmerican University of Beirut Medical Center

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Previous thoracic surgery with an incision of >2 cm

Patient's refusal

Allergy to local anesthetics

Pregnant women

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: Paravertebral blockActive comparator 1 intervention
Group B: Erector Spinae blockExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Chronic pain

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

Time frame
3 months after mastectomy

Secondary outcomes

1

Cumulative opioid consumption

Cumulative opioid consumption

Time frame
Amount of opioids used by the patient 48 hours after the procedure
2

Pain score

Pain score measured using NRS scale (0-10)

Time frame
Pain score measured using NRS scale (0-10) on arrival to the PACU,12 hour, 24 hour,and 48 hour after the procedure
3

Time needed for performing the block

Time needed for performing the block in minutes

Time frame
Time needed for performing the block (Perioperative)
4

Complications

Incidence of complications (Yes/No)

Time frame
Incidence of complications (Yes/No) (Perioperative)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

American University of Beirut Medical Center

Lead sponsor

Source ClinicalTrials.gov
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