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Completed

NCT Number: NCT01089933

Reducing Pain and Disability After Breast Cancer Surgery

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.

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Key information

Conditions

Breast Cancer Agnosia Breast Diseases Breast Neoplasms Chronic Pain Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thoracic paravertebral block (TPVB)

Procedure

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 names: Regional analgesia; neural blockade

Local Anesthetic

Procedure

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 names: local anesthesia

Primary outcomes

  1. The Proportion of Individuals Reporting Chronic Postoperative Pain 12 Months Following Breast Cancer Surgery With Lymph Node Dissection.

    Time frame: 1 year

Secondary outcomes

  1. 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

    Brief Pain Inventory (BPI); Flexion, extension, abduction, internal, and external rotation of the shoulder; Constant score; Quality of life was assessed using the FACTB4 and the SF-12 Health Survey (SF12); Details of the surgery, chemotherapy, and/or radiation therapy were recorded

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • Canadian Breast Cancer Foundation

Registry information

Official study title

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

Acronym: RELIeF

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Mar 19, 2010
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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