Clinical trial NCT01654432: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Diseases
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
First posted: 2012-07-31
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The primary outcome measure is the quality of recovery at discharge as assessed by the QoR27
timeFrame: Within 24 hours postoperatively
measure: The primary outcome measure is the quality of recovery post operatively, as assessed by the QoR27
timeFrame: on average between 24-48 hours postoperatively
measure: The primary outcome measure is the quality of recovery at discharge as assessed by the QoR27
timeFrame: On average 72-96 hours post operatively
measure: The primary outcome measure is the quality of recovery post operatively as assessed by the QoR27
timeFrame: On average 7-8 days postoperatively
Secondary outcomes:
measure: Neuropathic pain
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Women's College Hospital
name: Pamela Morgan, MD, CCFP, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: