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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

NCT ID: NCT01654432

Last Updated: 2013-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-12-31

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.

Detailed Description

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Conditions

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Breast Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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General anaesthesia and sham nerve block

Breast cancer surgery under general anaesthesia

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Paravertebral Blocks (PVB)

Breast cancer surgery under ultrasound-guided paravertebral blocks plus general anesthesia

Group Type ACTIVE_COMPARATOR

Paravertebral Blocks (PVB)

Intervention Type OTHER

Interventions

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Paravertebral Blocks (PVB)

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ontario Ministry of Health and Long Term Care

OTHER_GOV

Sponsor Role collaborator

Women's College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pamela Morgan, MD, CCFP, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Locations

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Women's College Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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2011-0004-B

Identifier Type: -

Identifier Source: org_study_id