Reducing Pain and Disability After Breast Cancer Surgery (RELIeF)

Ottawa Hospital Research Institute

Status: Completed

Conditions: Breast Cancer; Chronic Pain

Treatments: Procedure: Thoracic Paravertebral Block (TPVB); Procedure: Local Anesthetic

Study type: Interventional

Funder types: Other

Identifiers

NCT01089933

2006711-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 129 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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129 participants in 2 patient groups

Thoracic PVB + multimodal anesthesia

Experimental group

Description:

Thoracic PVB + multimodal anesthesia

Treatment:

Procedure: Thoracic Paravertebral Block (TPVB)

Local anesthetic + multi-modal analgesia

Active Comparator group

Description:

Local anesthetic + multi-modal analgesia

Treatment:

Procedure: Local Anesthetic