Erector Spinae Block vs. Placebo Block Study

Launched by WOMEN'S COLLEGE HOSPITAL · Jun 5, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at a method called the Erector Spinae Block, which is a type of nerve block used during breast cancer surgery. The goal is to see if this technique can help patients manage pain better after surgery compared to a placebo, which is a fake treatment. Using nerve blocks can reduce reliance on stronger pain medications, leading to less nausea and quicker recovery times for patients.

To participate in this trial, patients need to be between the ages of 18 and 75 and have a body mass index (BMI) under 35. They should be scheduled for a same-day surgery and must not have had previous major breast surgery or certain medical conditions that could complicate treatment. Participants will receive either the Erector Spinae Block or the placebo during their surgery and be monitored for how well they manage pain afterward. It's important for anyone considering this trial to understand the criteria and talk to their doctor to see if they qualify.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ASA classification: I-III
• • BMI \< 35 kg/m2
• • Day surgery procedure
• Exclusion Criteria:
• • Prior ipsilateral breast surgery, excluding lumpectomy
• • Pre-existing neurological deficit or peripheral neuropathy involving the ipsilateral chest
• • Severe, poorly controlled cardiac conditions, significant arrhythmias, severe valvular heart diseases
• • Severe, poorly controlled respiratory conditions (severe COPD, severe interstitial lung disease, severe / poorly controlled asthma)
• • Contraindication to regional anaesthesia (e.g. bleeding diathesis, coagulopathy, sepsis, infection at the site of potential needle puncture on the posterior chest)
• • Patient refusal
• • Chronic pain disorder
• • Chronic opioid use (≥30 mg oxycodone / day)
• • Contraindication (or allergy) to a component of multi-modal analgesia protocol
• • Allergy to amide local anaesthetics used in nerve blocks
• • Contraindications to any of the components of the standardized general anaesthesia
• • Significant psychiatric disorder that would preclude objective study assessment
• • Pregnancy/ women with nursing infants
• • Unable to provide informed consent
• • Unable to speak and read English