Back to resultsA Randomized Controlled Comparative Study of Ultrasound-guided Paravertebral Blocks as Part of a Multimodal Regimen for Ambulatory Breast Cancer Surgery
Primary Purpose
Breast Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Paravertebral Blocks (PVB)
Sponsored by
About this trial
This is an interventional treatment trial for Breast Diseases
Eligibility Criteria
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
Sites / Locations
- Women's College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
General anaesthesia and sham nerve block
Paravertebral Blocks (PVB)
Arm Description
Breast cancer surgery under general anaesthesia
Breast cancer surgery under ultrasound-guided paravertebral blocks plus general anesthesia
Outcomes
Primary Outcome Measures
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)
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)
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)
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)
Secondary Outcome Measures
Neuropathic pain
DN4
Full Information
NCT ID
NCT01654432
First Posted
July 27, 2012
Last Updated
November 15, 2013
Sponsor
Women's College Hospital
Collaborators
Ontario Ministry of Health and Long Term Care
1. Study Identification
Unique Protocol Identification Number
NCT01654432
Brief Title
A Randomized Controlled Comparative Study of Ultrasound-guided Paravertebral Blocks as Part of a Multimodal Regimen for Ambulatory Breast Cancer Surgery
Official Title
A Randomized Controlled Comparative Study of Ultrasound-guided Paravertebral Blocks as Part of a Multimodal Regimen for Ambulatory Breast Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women's College Hospital
Collaborators
Ontario Ministry of Health and Long Term Care
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
General anaesthesia and sham nerve block
Arm Type
Placebo Comparator
Arm Description
Breast cancer surgery under general anaesthesia
Arm Title
Paravertebral Blocks (PVB)
Arm Type
Active Comparator
Arm Description
Breast cancer surgery under ultrasound-guided paravertebral blocks plus general anesthesia
Intervention Type
Other
Intervention Name(s)
Paravertebral Blocks (PVB)
Primary Outcome Measure Information:
Title
The primary outcome measure is the quality of recovery at discharge as assessed by the QoR27
Description
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
Title
The primary outcome measure is the quality of recovery post operatively, as assessed by the QoR27
Description
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
Title
The primary outcome measure is the quality of recovery at discharge as assessed by the QoR27
Description
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
Title
The primary outcome measure is the quality of recovery post operatively as assessed by the QoR27
Description
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 Outcome Measure Information:
Title
Neuropathic pain
Description
DN4
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Morgan, MD, CCFP, FRCPC
Organizational Affiliation
Women's College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's College Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Randomized Controlled Comparative Study of Ultrasound-guided Paravertebral Blocks as Part of a Multimodal Regimen for Ambulatory Breast Cancer Surgery
We'll reach out to this number within 24 hrs