Reducing Pain and Disability After Breast Cancer Surgery
- Conditions
- Chronic PainBreast Cancer
- Interventions
- Procedure: Local AnestheticProcedure: 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
- 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)
- 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
Group Intervention Description Local anesthetic + multi-modal analgesia Local Anesthetic Local anesthetic + multi-modal analgesia Thoracic PVB + multimodal anesthesia Thoracic Paravertebral Block (TPVB) Thoracic PVB + multimodal anesthesia
- Primary Outcome Measures
Name Time Method The Proportion of Individuals Reporting Chronic Postoperative Pain 12 Months Following Breast Cancer Surgery With Lymph Node Dissection. 1 year
- Secondary Outcome Measures
Name Time Method 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