Overview

This trial is active, not recruiting.

Condition breast diseases
Treatment paravertebral blocks (pvb)
Sponsor Women's College Hospital
Collaborator Ontario Ministry of Health and Long Term Care
Start date July 2011
End date May 2013
Trial size 60 participants
Trial identifier NCT01654432, 2011-0004-B

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Breast cancer surgery under general anaesthesia
(Active Comparator)
Breast cancer surgery under ultrasound-guided paravertebral blocks plus general anesthesia
paravertebral blocks (pvb)

Primary Outcomes

Measure
The primary outcome measure is the quality of recovery at discharge as assessed by the QoR27
time frame: Within 24 hours postoperatively
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
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
The primary outcome measure is the quality of recovery post operatively as assessed by the QoR27
time frame: On average 7-8 days postoperatively

Secondary Outcomes

Measure
Neuropathic pain
time frame: 6 months

Eligibility Criteria

Female participants from 18 years up to 85 years old.

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

Additional Information

Official title A Randomized Controlled Comparative Study of Ultrasound-guided Paravertebral Blocks as Part of a Multimodal Regimen for Ambulatory Breast Cancer Surgery
Principal investigator Pamela Morgan, MD, CCFP, FRCPC
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Women's College Hospital.