A Randomized Controlled Comparative Study of Ultrasound-guided Paravertebral Blocks as Part of a Multimodal Regimen for Ambulatory Breast Cancer Surgery
18 Years
85 Years
Female
Breast Diseases
Trial Information
A Randomized Controlled Comparative Study of Ultrasound-guided Paravertebral Blocks as Part of a Multimodal Regimen for Ambulatory Breast Cancer Surgery
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
The primary outcome measure is the quality of recovery at discharge as assessed by the QoR27
Outcome Description:
The patient will be met with by the study coordinator, just before discharge to administer the Quality of Recovery Questionnaire (QoR27)
Outcome Time Frame:
Within 24 hours postoperatively
Safety Issue:
No
Principal Investigator
Pamela Morgan, MD, CCFP, FRCPC
Investigator Role:
Principal Investigator
Investigator Affiliation:
Women's College Hospital
Authority:
Canada: Ethics Review Committee
Study ID:
2011-0004-B
NCT ID:
NCT01654432
Start Date:
July 2011
Completion Date:
May 2013
Related Keywords:
- Breast Diseases
- Breast Neoplasms
- Breast Diseases
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