A Randomized Controlled Comparative Study of Ultrasound-guided Paravertebral Blocks as Part of a Multimodal Regimen for Ambulatory Breast Cancer Surgery
This study is currently recruiting participants.
Verified August 2012 by Women's College Hospital
Sponsor:
Women's College Hospital
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Women's College Hospital
ClinicalTrials.gov Identifier:
NCT01654432
First received: July 27, 2012
Last updated: August 1, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Diseases |
Other: Paravertebral Blocks (PVB) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Comparative Study of Ultrasound-guided Paravertebral Blocks as Part of a Multimodal Regimen for Ambulatory Breast Cancer Surgery |
Resource links provided by NLM:
Further study details as provided by Women's College Hospital:
Primary Outcome Measures:
- The primary outcome measure is the quality of recovery at discharge as assessed by the QoR27 [ Time Frame: Within 24 hours postoperatively ] [ Designated as safety issue: No ]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 [ Time Frame: on average between 24-48 hours postoperatively ] [ Designated as safety issue: No ]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 [ Time Frame: On average 72-96 hours post operatively ] [ Designated as safety issue: No ]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 [ Time Frame: On average 7-8 days postoperatively ] [ Designated as safety issue: No ]The patient will be contacted by the study coordinator, 7 days following their surgery to administer the Quality of Recovery Questionnaire (QoR27)
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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) |
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01654432
Contacts
| Contact: Mary Li, M.Sc. | 4163236400 ext 4087 | mary.li@wchospital.ca |
Locations
| Canada, Ontario | |
| Women's College Hospital | Recruiting |
| Toronto, Ontario, Canada, M5S 1B2 | |
| Contact: Mary Li, M.Sc. 4163236400 ext 4087 mary.li@wchospital.ca | |
Sponsors and Collaborators
Women's College Hospital
Ontario Ministry of Health and Long Term Care
Investigators
| Principal Investigator: | Pamela Morgan, MD, CCFP, FRCPC | Women's College Hospital |
More Information
No publications provided
| Responsible Party: | Women's College Hospital |
| ClinicalTrials.gov Identifier: | NCT01654432 History of Changes |
| Other Study ID Numbers: | 2011-0004-B |
| Study First Received: | July 27, 2012 |
| Last Updated: | August 1, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Additional relevant MeSH terms:
|
Breast Neoplasms Breast Diseases Neoplasms by Site Neoplasms Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013