Reducing Pain and Disability After Breast Cancer Surgery (RELIeF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01089933
Recruitment Status : Completed
First Posted : March 19, 2010
Last Update Posted : May 11, 2017
Canadian Breast Cancer Foundation
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Chronic Pain Procedure: Thoracic Paravertebral Block (TPVB) Procedure: Local Anesthetic Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Thoracic Paravertebral Block in Reducing Chronic Pain and Disability After Breast Cancer Surgery With Axillary Lymph Node Dissection
Study Start Date : September 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Thoracic PVB + multimodal anesthesia
Thoracic PVB + multimodal anesthesia
Procedure: Thoracic Paravertebral Block (TPVB)
The middle of the spinous process above the nerve to be blocked is located and the overlying skin marked 2.5 centimeters lateral to this. Subcutaneous lidocaine is injected and a 22 G Tuohy tipped 8 cm needle is inserted at this level and advanced to identify the transverse process. The needle is then moved caudad off the transverse process and inserted a centimeter into the paravertebral space. Five mls of 0.5% ropivacaine with 1:200,000 epinephrine is injected at each paravertebral space. Blocks adjacent to the C7-T5 spinous processes are performed. For patients randomized to the LA group: The patients are identically positioned, sedated and identical landmarks are used to perform sham paravertebral blocks via a subcutaneous saline injection of 0.5mL with a 25G needle at each level.
Other Name: Regional analgesia; neural blockade

Active Comparator: Local anesthetic + multi-modal analgesia
Local anesthetic + multi-modal analgesia
Procedure: Local Anesthetic
At the conclusion of surgery, the surgeon will infiltrate the incision with 10 ml of saline 0.9% (TPVB group) or 0.5% ropivacaine (LA group). An axillary drain will be placed. After closure of the wound, 20 ml of saline 0.9% (TPVB group) or 0.5% ropivacaine (LA group) will be injected through the drain and the drain clamped for 30 minutes after injection.
Other Name: local anesthesia

Primary Outcome Measures :
  1. The proportion of individuals reporting chronic postoperative pain 12 months following breast cancer surgery with lymph node dissection. Chronic pain will be defined by a Numeric Rating Scale (NRS) score of >3 (rest or with arm movement). [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 1 year ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01089933

Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Breast Cancer Foundation
Principal Investigator: Michelle Chiu, MD The Ottawa Hospital / Ottawa Health Research Institute

Publications of Results:
Responsible Party: Ottawa Hospital Research Institute Identifier: NCT01089933     History of Changes
Other Study ID Numbers: 2006711-01
to be entered
First Posted: March 19, 2010    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017

Keywords provided by Ottawa Hospital Research Institute:
Local Anesthetics
Quality of life
Paravertebral blocks
Arm morbidity

Additional relevant MeSH terms:
Breast Neoplasms
Chronic Pain
Neoplasms by Site
Breast Diseases
Skin Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents