MedPath

Reducing Pain and Disability After Breast Cancer Surgery

Not Applicable
Completed
Conditions
Chronic Pain
Breast Cancer
Interventions
Procedure: Local Anesthetic
Procedure: Thoracic Paravertebral Block (TPVB)
Registration Number
NCT01089933
Lead Sponsor
Ottawa Hospital Research Institute
Brief Summary

The purpose of this study is to determine if the combination of thoracic paravertebral block and multimodal analgesia will decrease chronic pain and arm morbidity in patients undergoing breast cancer surgery with lymph node dissection as compared to patients receiving local anesthesia with multimodal analgesia.

Detailed Description

Sixty percent of breast cancer patients undergo some form of breast surgery in the treatment of the early stages of the disease. The recovery from surgery can be associated with severe disabling pain persisting beyond 12 months after surgery. Research in pain has shown that early intervention of acute pain can prevent long term chronic pain.

At The Ottawa Hospital, patients receive either paravertebral blocks or wound infiltration with local anesthetic for postoperative pain management. We would like to compare these two methods of pain control to determine an analgesic technique that will reduce acute and chronic pain, and maximally improve long-term functional recovery and patient's quality of life.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
129
Inclusion Criteria
  • Patients with diagnosis of breast cancer
  • Scheduled for elective modified radical mastectomy, simple mastectomy with SLNB, breast conserving surgery (ie lumpectomy, segmental mastectomy) with ALND or ALND alone (after positive SLNB)
Exclusion Criteria
  • American Society of Anesthesiologist (ASA) class 4 or 5
  • Patients with contraindications to TPVB
  • Allergy to study medications
  • Chronic opioid use defined as daily consumption of greater than 20 mg of oral morphine or equivalent for >7days
  • Renal insufficiency defined as a creatinine clearance <40ml/min as calculated using the Cockroft-Gault formula
  • Preoperative radiation therapy
  • Inability to achieve normal shoulder range of motion as defined as <100o of shoulder abduction or flexion

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Local anesthetic + multi-modal analgesiaLocal AnestheticLocal anesthetic + multi-modal analgesia
Thoracic PVB + multimodal anesthesiaThoracic Paravertebral Block (TPVB)Thoracic PVB + multimodal anesthesia
Primary Outcome Measures
NameTimeMethod
The Proportion of Individuals Reporting Chronic Postoperative Pain 12 Months Following Breast Cancer Surgery With Lymph Node Dissection.1 year
Secondary Outcome Measures
NameTimeMethod
Arm Morbidity, Shoulder Range of Motion, Quality of Analgesia, Arm Lymphedema, Time to Meet Discharge Criteria, Quality of Recovery, Quality of Life, Incidence of Postoperative Side Effects.1 year

Brief Pain Inventory (BPI); Flexion, extension, abduction, internal, and external rotation of the shoulder; Constant score; Quality of life was assessed using the FACTB4 and the SF-12 Health Survey (SF12); Details of the surgery, chemotherapy, and/or radiation therapy were recorded

Trial Locations

Locations (1)

The Ottawa Hospital

🇨🇦

Ottawa, Ontario, Canada

© Copyright 2025. All Rights Reserved by MedPath