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Efficacy of Thoracic Paravertebral Block in Reducing Chronic Pain and Disability After Breast Cancer Surgery With Axillary Lymph Node Dissection


Phase 4
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Chronic Pain

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Trial Information

Efficacy of Thoracic Paravertebral Block in Reducing Chronic Pain and Disability After Breast Cancer Surgery With Axillary Lymph Node Dissection


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

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).

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Michelle Chiu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Ottawa Hospital / Ottawa Health Research Institute

Authority:

Canada: Ethics Review Committee

Study ID:

2006711-01

NCT ID:

NCT01089933

Start Date:

September 2009

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • Chronic Pain
  • Anesthesia
  • Local Anesthetics
  • Analgesia
  • Quality of life
  • Paravertebral blocks
  • Arm morbidity
  • Breast Neoplasms

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