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Erector Spinae Block for Post-Operative Pain in Breast Cancer Surgery

N/A

Waitlist Available

Led By Richard Brull, MD,FRCPC

Research Sponsored by Women's College Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Day surgery procedure

Be older than 18 years old

Must not have

Allergy to amide local anaesthetics used in nerve blocks

Severe, poorly controlled cardiac conditions, significant arrhythmias, severe valvular heart diseases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months post operatively

Awards & highlights

Summary

This trial is testing different regional anaesthesia techniques to see which one provides the best post-operative analgesia for breast cancer surgery patients.

Who is the study for?

This trial is for breast cancer surgery patients with an ASA classification of I-III and a BMI under 35. It's suitable for those having day surgery without severe respiratory or cardiac conditions, no history of significant chest surgeries (except lumpectomy), and not on high-dose opioids. Participants mustn't have allergies to local anaesthetics, be pregnant/nursing, or unable to consent.

What is being tested?

The study tests the effectiveness of erector spinae plane block versus a placebo in managing post-operative pain after breast cancer surgery. The goal is to see if this technique can improve recovery by reducing opioid use and side effects like nausea while promoting earlier discharge.

What are the potential side effects?

Potential side effects may include discomfort at the injection site, risk of infection from needle puncture, possible nerve damage leading to numbness or weakness, allergic reactions to the anaesthetic used in the block, and failure of the block leading to inadequate pain relief.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My surgery is scheduled as a day procedure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to certain local anesthetics used for numbing.

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I do not have severe heart conditions or irregular heartbeats.

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I am allergic to a drug used in pain management protocols.

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I have chosen not to participate in the trial.

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I have a long-term pain condition.

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I take 30 mg or more of oxycodone daily.

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I am allergic or react badly to certain anesthesia drugs.

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I cannot have regional anesthesia due to certain health issues.

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I am unable to understand and agree to the study's details on my own.

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I have nerve issues or weakness in the same side of my chest as my cancer.

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I do not have severe breathing problems like COPD, interstitial lung disease, or uncontrolled asthma.

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I have had breast surgery before, but not a lumpectomy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months post operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acute postoperative pain at rest

Quality of postoperative recovery (QoR 15)

Secondary study objectives

Block-related complications

Duration of phase I (PACU) and phase II (surgical day care, SDC) stay

Intraoperative opioid consumption

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Erector spinae plane (ESP) block groupExperimental Treatment1 Intervention

Local anaesthetic infiltration utilising 1% lidocaine will occur, and an 80mm 22G block needle will be inserted using an in-plane cranial to caudad approach, the needle will be advanced to target the interfascial plane deep to the erector spinae muscle at the T2 transverse process. Once the needle tip is in the correct position, 20 ml of the local anaesthetic (ropivacaine 0.5% with 1:400,000 epinephrine) will be administered slowly in 5 ml aliquots under frequent aspiration and correct spread in the interfascial plane will be observed.

Group II: Control GroupPlacebo Group1 Intervention

Patients randomised to the Control group will then receive a sham subcutaneous injection of 0.5ml normal saline injected at the same site as the ESP block (see above) under ultrasound guidance to stimulate a real block procedure.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Erector spinae plane block

2020

Completed Phase 4

~1290

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Women's College HospitalLead Sponsor

106 Previous Clinical Trials

43,528 Total Patients Enrolled

6 Trials studying Breast Cancer

6,248 Patients Enrolled for Breast Cancer

Richard Brull, MD,FRCPCPrincipal InvestigatorWomen's College Hospital

Media Library

Breast Cancer Research Study Groups: Control Group, Erector spinae plane (ESP) block group

Breast Cancer Clinical Trial 2023: Erector spinae plane block Highlights & Side Effects. Trial Name: NCT03978780 — N/A

~40 spots leftby Sep 2025

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