Reducing Pain and Disability After Breast Cancer Surgery

Breast Cancer Clinical Trial

— RELIeF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01089933
• Other study ID #: 2006711-01
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: June 2013

Study information

• Verified date: November 2023
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: June 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chronic Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Breast Cancer Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Proportion of Individuals Reporting Chronic Postoperative Pain 12 Months Following Breast Cancer Surgery With Lymph Node Dissection.		1 year
Secondary	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.	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	1 year

External Links

•   full publication, including results