Reducing Pain and Disability After Breast Cancer Surgery (RELIeF)

This study has been completed.
Sponsor:
Collaborator:
Canadian Breast Cancer Foundation
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01089933
First received: March 17, 2010
Last updated: October 14, 2014
Last verified: October 2014

March 17, 2010
October 14, 2014
September 2009
September 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01089933 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Reducing Pain and Disability After Breast Cancer Surgery
Efficacy of Thoracic Paravertebral Block in Reducing Chronic Pain and Disability After Breast Cancer Surgery With Axillary Lymph Node Dissection

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Breast Cancer
  • Chronic Pain
  • 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
  • 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
  • Experimental: Thoracic PVB + multimodal anesthesia
    Thoracic PVB + multimodal anesthesia
    Intervention: Procedure: Thoracic Paravertebral Block (TPVB)
  • Active Comparator: Local anesthetic + multi-modal analgesia
    Local anesthetic + multi-modal analgesia
    Intervention: Procedure: Local Anesthetic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
145
June 2013
September 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01089933
2006711-01, to be entered
No
Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
Canadian Breast Cancer Foundation
Principal Investigator: Michelle Chiu, MD The Ottawa Hospital / Ottawa Health Research Institute
Ottawa Hospital Research Institute
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP