A Randomized Controlled Comparative Study of Ultrasound-guided Paravertebral Blocks as Part of a Multimodal Regimen for Ambulatory Breast Cancer Surgery

Study Overview
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Brief Summary
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General anesthesia and morphine based pain medicine analgesia has been the mainstay of practice in breast cancer surgery at Women's College Hospital. There is evidence to suggest that patients have a better recovery, with less pain and nausea and vomiting when nerve blocks or freezing of nerves are given in addition to a general anesthetic. Specifically for breast cancer surgery, evidence has suggested that the use of paravertebral blocks provide patients with a better quality of recovery after surgery. The aim of this study is to examine whether patients who receive the nerve blocks using an ultrasound machine in addition to general anesthesia have a better quality of recovery than patients who receive a general anesthetic alone. The hypothesis is that patients receiving ultrasound-guided paravertebral blocks (PVB) with propofol-based general anesthesia (GA) will have a better quality of recovery than patients receiving general anesthesia-opioid-analgesia. Quality of recovery will be assessed using a modification of the QoR-27, a validated instrument to assess postoperative recovery in an ambulatory surgical population.

Official Title
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A Randomized Controlled Comparative Study of Ultrasound-guided Paravertebral Blocks as Part of a Multimodal Regimen for Ambulatory Breast Cancer Surgery

Conditions
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Breast Diseases

Intervention / Treatment
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* Other: Paravertebral Blocks (PVB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with breast cancer at stage T1-3, N0-2, M0, presenting for unilateral complete or partial mastectomy with or without sentinel lymph node dissection, with or without implant insertion ASA physical status I-II 18-85 years of age, inclusive BMI ≤ 35 Exclusion Criteria: Contraindications to paravertebral nerve block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the back area) Pregnancy History of alcohol or drug dependency/abuse History of significant psychiatric conditions that may affect patient assessment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: General anaesthesia and sham nerve block<br>Breast cancer surgery under general anaesthesia | |
| Active Comparator: Paravertebral Blocks (PVB)<br>Breast cancer surgery under ultrasound-guided paravertebral blocks plus general anesthesia | Other: Paravertebral Blocks (PVB)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure is the quality of recovery at discharge as assessed by the QoR27 | The patient will be met with by the study coordinator, just before discharge to administer the Quality of Recovery Questionnaire (QoR27) | Within 24 hours postoperatively | 
| The primary outcome measure is the quality of recovery post operatively, as assessed by the QoR27 | The patient will be contacted by the study coordinator, 2 days following their surgery to administer the Quality of Recovery Questionnaire (QoR27) | on average between 24-48 hours postoperatively | 
| The primary outcome measure is the quality of recovery at discharge as assessed by the QoR27 | The patient will be contacted by the study coordinator, 4 days following their surgery to administer the Quality of Recovery Questionnaire (QoR27) | On average 72-96 hours post operatively | 
| The primary outcome measure is the quality of recovery post operatively as assessed by the QoR27 | The patient will be contacted by the study coordinator, 7 days following their surgery to administer the Quality of Recovery Questionnaire (QoR27) | On average 7-8 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropathic pain | DN4 | 6 months |