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Reducing Pain and Disability After Breast Cancer Surgery (RELIeF)

Primary Purpose

Breast Cancer, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Thoracic Paravertebral Block (TPVB)
Local Anesthetic
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Anesthesia, Local Anesthetics, Analgesia, Quality of life, Paravertebral blocks, Arm morbidity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • The Ottawa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Thoracic PVB + multimodal anesthesia

Local anesthetic + multi-modal analgesia

Arm Description

Thoracic PVB + multimodal anesthesia

Local anesthetic + multi-modal analgesia

Outcomes

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).

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.

Full Information

First Posted
March 17, 2010
Last Updated
May 9, 2017
Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Breast Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01089933
Brief Title
Reducing Pain and Disability After Breast Cancer Surgery
Acronym
RELIeF
Official Title
Efficacy of Thoracic Paravertebral Block in Reducing Chronic Pain and Disability After Breast Cancer Surgery With Axillary Lymph Node Dissection
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Breast Cancer Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Chronic Pain
Keywords
Anesthesia, Local Anesthetics, Analgesia, Quality of life, Paravertebral blocks, Arm morbidity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thoracic PVB + multimodal anesthesia
Arm Type
Experimental
Arm Description
Thoracic PVB + multimodal anesthesia
Arm Title
Local anesthetic + multi-modal analgesia
Arm Type
Active Comparator
Arm Description
Local anesthetic + multi-modal analgesia
Intervention Type
Procedure
Intervention Name(s)
Thoracic Paravertebral Block (TPVB)
Other Intervention Name(s)
Regional analgesia; neural blockade
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Local Anesthetic
Other Intervention Name(s)
local anesthesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Chiu, MD
Organizational Affiliation
The Ottawa Hospital / Ottawa Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
24165901
Citation
Chiu M, Bryson GL, Lui A, Watters JM, Taljaard M, Nathan HJ. Reducing persistent postoperative pain and disability 1 year after breast cancer surgery: a randomized, controlled trial comparing thoracic paravertebral block to local anesthetic infiltration. Ann Surg Oncol. 2014 Mar;21(3):795-801. doi: 10.1245/s10434-013-3334-6. Epub 2013 Oct 29.
Results Reference
result

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Reducing Pain and Disability After Breast Cancer Surgery

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