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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months post operatively

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

My surgery is scheduled as a day procedure.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acute postoperative pain at rest

Quality of postoperative recovery (QoR 15)

Secondary outcome measures

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

~1360

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Women's College HospitalLead Sponsor

100 Previous Clinical Trials

38,743 Total Patients Enrolled

5 Trials studying Breast Cancer

1,748 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the main purpose of this research experiment?

"During the 24 hours after surgery, primary outcome will be monitored to assess acute restful pain. Secondary evaluations include potential opioid-related side effects (e.g., nausea, vomiting and itching), cumulative oral morphine equivalent post procedure, and patient satisfaction with prescribed analgesia."

Answered by AI

Are there any opportunities to partake in this research experiment at present?

"Unfortunately, the details hosted on clinicaltrials.gov indicate that this study is not accepting applications at present. Originally posted in September of 2022, with its last update occurring in March 10th 2021; although recruiting has ceased for this trial, there are still over two-thousand six hundred and forty one other medical studies searching for participants."

Answered by AI

Is this research study accepting participants who are thirty and above in age?

"Pursuant to the study's rules, the youngest participants must be 18 while the oldest may not exceed 65."

Answered by AI

May I be included in this experiment?

"The ongoing clinical trial is recruiting 60 participants who meet the criteria of BMI below 35 kg/m2 and requiring day surgery procedure. The age range for potential candidates lies between 18-65 years old."

Answered by AI

Recent research and studies

Regional Anesthesia & Pain MedicineJournal

Interfascial Block at the Serratus Muscle Plane Versus Conventional Analgesia in Breast Surgery: A Randomized Controlled Trial

Mazzinari, Guido, Lucas Rovira, Alma Casasempere, Juan Ortega, Luis Cort, José-Miguel Esparza-Miñana, and Moncef Belaouchi. 2019. “Interfascial Block at the Serratus Muscle Plane Versus Conventional Analgesia in Breast Surgery: A Randomized Controlled Trial”. Regional Anesthesia & Pain Medicine. BMJ. doi:10.1136/rapm-2018-000004.

Journal of Clinical AnesthesiaJournal

Ultrasound Guided Erector Spinae Plane Block Reduces Postoperative Opioid Consumption Following Breast Surgery: A Randomized Controlled Study

Gürkan, Yavuz, Can Aksu, Alparslan Kuş, Ufuk H. Yörükoğlu, and Cennet T. Kılıç. 2018. “Ultrasound Guided Erector Spinae Plane Block Reduces Postoperative Opioid Consumption Following Breast Surgery: A Randomized Controlled Study”. Journal of Clinical Anesthesia. Elsevier BV. doi:10.1016/j.jclinane.2018.06.033.

AnaesthesiaJournal

Serratus Plane Block: A Novel Ultrasound-guided Thoracic Wall Nerve Block

Blanco, R., T. Parras, J. G. McDonnell, and A. Prats-Galino. 2013. “Serratus Plane Block: A Novel Ultrasound-guided Thoracic Wall Nerve Block”. Anaesthesia. Wiley. doi:10.1111/anae.12344.

Regional Anesthesia and Pain MedicineJournal