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

Women's College Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Breast Diseases

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: On average 7-8 days postoperatively

Secondary Outcomes

Neuropathic pain

DN4

Time frame: 6 months