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Clinical Trials in Canada / NCT03978780
Starting soon Not applicable

Erector Spinae Block vs. Placebo Block Study

NCT03978780 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2026-06
Last updated
2025-07-16

Condition(s) studied

Breast CancerNerve BlockRegional AnesthesiaNeuromuscular Blockade

Investigational drug(s) / intervention(s)

Erector spinae plane blockPlacebo Block

Erector spinae plane block: 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.

Placebo Block: 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 under ultrasound guidance to stimulate a real block procedure.

Study summary

Regional anaesthesia combined with general anaesthesia has become common in the perioperative management of breast cancer surgery patients. Regional techniques have been recognised to provide excellent post-operative analgesia. It enhances multi-modal analgesia regimes while being opioid sparing, reducing incidence of post-operative nausea and vomiting and allowing earlier mobilisation/discharge and improving treatment success. Therefore identifying the correct regional anaesthetic technique for this group of patients is important in providing optimum peri-operative care.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Women's College Hospital Toronto Ontario

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03978780 on ClinicalTrials.gov ↗ ← All trials in Canada