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

NCT01654432 | Unknown

• 1 other identifier: 2011-0004-B
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Diseases

Outcome Measures

Primary Outcomes (4)

• 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)

  Within 24 hours postoperatively

• 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)

  on average between 24-48 hours postoperatively

• 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)

  On average 72-96 hours post operatively

• 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)

  On average 7-8 days postoperatively

Secondary Outcomes (1)

• Neuropathic pain

  6 months

Study Arms (2)

General anaesthesia and sham nerve block

PLACEBO COMPARATOR

Breast cancer surgery under general anaesthesia

Paravertebral Blocks (PVB)

ACTIVE COMPARATOR

Breast cancer surgery under ultrasound-guided paravertebral blocks plus general anesthesia

Other: Paravertebral Blocks (PVB)

Interventions

Paravertebral Blocks (PVB) OTHER

Paravertebral Blocks (PVB)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age, inclusive
• BMI ≤ 35

You may not qualify if:

• 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

Sponsors & Collaborators

• Women's College Hospital: lead
• Ontario Ministry of Health and Long Term Care: collaborator

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

MeSH Terms

Conditions

Breast Diseases

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pamela Morgan, MD, CCFP, FRCPC

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2012
• First Posted: July 31, 2012
• Study Start: July 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 19, 2013

Record last verified: 2013-11

Locations

CA (1)