Reducing Pain and Disability After Breast Cancer Surgery (RELIeF)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Ottawa Hospital Research Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Canadian Breast Cancer Foundation
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01089933
First received: March 17, 2010
Last updated: July 26, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Breast Cancer
Chronic Pain
Procedure: Thoracic Paravertebral Block (TPVB)
Procedure: Local Anesthetic
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 180
Study Start Date: September 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089933

Contacts
Contact: Sharon Finlay, RN, CCRP 613-761-5495 sfinlay@ottawahospital.on.ca
Contact: Denise Wozny, BA 613-7614969 dwozny@ottawahospital.on.ca

Locations
Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Principal Investigator: Michelle Chiu, MD         
Sub-Investigator: Anne Lui, MD         
Sub-Investigator: Gregory L Bryson, MD         
Sub-Investigator: Christopher Chadwick, MD         
Sub-Investigator: Roanne Segal, MD         
Sub-Investigator: Peter Cross, MD         
Sub-Investigator: Taljaard Monica, PhD         
Sub-Investigator: Evans Holly, MD         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Breast Cancer Foundation
Investigators
Principal Investigator: Michelle Chiu, MD The Ottawa Hospital / Ottawa Health Research Institute
  More Information

No publications provided

Responsible Party: Dr Michelle Chiu, The Ottawa Hospital
ClinicalTrials.gov Identifier: NCT01089933     History of Changes
Other Study ID Numbers: 2006711-01, to be entered
Study First Received: March 17, 2010
Last Updated: July 26, 2011
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on September 14, 2014