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

Women's College Hospital

Status: Unknown

Conditions: Breast Diseases

Treatments: Other: Paravertebral Blocks (PVB)

Study type: Interventional

Funder types: Other

Identifiers

NCT01654432

2011-0004-B

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

General anaesthesia and sham nerve block

Placebo Comparator group

Description:

Breast cancer surgery under general anaesthesia

Paravertebral Blocks (PVB)

Active Comparator group

Description:

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

Treatment:

Other: Paravertebral Blocks (PVB)