Clinical trial NCT01089933: Reducing Pain and Disability After Breast Cancer Surgery
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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Chronic Pain
Keywords: Anesthesia
Local Anesthetics
Analgesia
Quality of life
Paravertebral blocks
Arm morbidity
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Breast Cancer Foundation
First posted: 2010-03-19
Enrollment: 129
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The Proportion of Individuals Reporting Chronic Postoperative Pain 12 Months Following Breast Cancer Surgery With Lymph Node Dissection.
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital / Ottawa Health Research Institute
name: Michelle Chiu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.