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

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 Overview

• Status: Unknown
• Conditions: Breast Diseases
• Intervention / Treatment: Other: Paravertebral Blocks (PVB)

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 1B2
      • Women's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: General anaesthesia and sham nerve block; Breast cancer surgery under general anaesthesia
ACTIVE_COMPARATOR: Paravertebral Blocks (PVB); Breast cancer surgery under ultrasound-guided paravertebral blocks plus general anesthesia	Other: Paravertebral Blocks (PVB)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Women's College Hospital
• Collaborators: Ontario Ministry of Health and Long Term Care
• Investigators: Principal Investigator: Pamela Morgan, MD, CCFP, FRCPC, Women's College Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ACTUAL): May 1, 2013
• Study Completion (ANTICIPATED): December 1, 2013

Study Registration Dates

• First Submitted: July 27, 2012
• First Submitted That Met QC Criteria: July 27, 2012
• First Posted (ESTIMATE): July 31, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 19, 2013
• Last Update Submitted That Met QC Criteria: November 15, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases
• Other Study ID Numbers: 2011-0004-B