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

Not Applicable

• Conditions: Breast Diseases
• Interventions: Other: Paravertebral Blocks (PVB)

• Registration Number: NCT01654432
• Lead Sponsor: Women's College Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-07-27
• Study First Submitted QC: 2012-07-27
• Study First Posted: 2012-07-31
• Primary Completion: 2013-05
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-15
• Last Update Posted: 2013-11-19
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paravertebral Blocks (PVB)	Paravertebral Blocks (PVB)	Breast cancer surgery under ultrasound-guided paravertebral blocks plus general anesthesia

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Neuropathic pain	6 months	DN4

Trial Locations

Locations (1)

Women's College Hospital; 🇨🇦 Toronto, Ontario, Canada