Reducing Pain and Disability After Breast Cancer Surgery

NCT01089933 | Completed Results

• 1 other identifier: 2006711-01
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Chronic Pain

Keywords

Anesthesia; Local Anesthetics; Analgesia; Quality of life; Paravertebral blocks; Arm morbidity

Outcome Measures

Primary Outcomes (1)

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

  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.

  1 year

Study Arms (2)

Thoracic PVB + multimodal anesthesia

EXPERIMENTAL

Thoracic PVB + multimodal anesthesia

Procedure: Thoracic Paravertebral Block (TPVB)

Local anesthetic + multi-modal analgesia

ACTIVE COMPARATOR

Local anesthetic + multi-modal analgesia

Procedure: Local Anesthetic

Interventions

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.

Also known as: Regional analgesia; neural blockade

Thoracic PVB + multimodal anesthesia

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.

Also known as: local anesthesia

Local anesthetic + multi-modal analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Breast Cancer Foundation: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related 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. Ann Surg Oncol. 2014 Mar;21(3):795-801. doi: 10.1245/s10434-013-3334-6. Epub 2013 Oct 29.

  PMID: 24165901 RESULT

Related Links

• full publication, including results

MeSH Terms

Conditions

Breast Neoplasms; Chronic Pain; Agnosia

Interventions

Nerve Block; Anesthetics, Local; Anesthesia, Local

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Results Point of Contact

• Title: Dr Michelle Chiu
• Organization: OHRI

mchiu@toh.ca

613-798-5555

Study Officials

• Michelle Chiu, MD

  The Ottawa Hospital / Ottawa Health Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 19, 2010
• Study Start: September 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: June 1, 2013
• Last Updated: April 4, 2025
• Results First Posted: November 7, 2023

Record last verified: 2025-03

Locations

CA (1)