A Randomized Controlled Comparative Study of Ultrasound-guided Paravertebral Blocks as Part of a Multimodal Regimen for Ambulatory Breast Cancer Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
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: November 15, 2013
Last verified: November 2013
  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)


Secondary Outcome Measures:
  • Neuropathic pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    DN4


Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654432

Locations
Canada, Ontario
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
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: November 15, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Breast Diseases
Breast Neoplasms
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014