Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01231204
First received: October 27, 2010
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

Research study to determine if putting local anesthetic—or numbing medication—through a tiny tube placed next to the nerves that go to a breast prior to and following a mastectomy will decrease subsequent pain.


Condition Intervention Phase
Paravertebral Catheter Insertion
Mastectomy
Breast Cancer
Procedure: Placebo (normal saline) Continuous Infusion
Procedure: Ropivicaine 0.4% Continuous Infusion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Pain Scores (NRS) [ Time Frame: Day following Surgery ] [ Designated as safety issue: No ]
    Pain score on the 0-10 Numeric Rating Scale given as part of the Brief Pain Inventory


Secondary Outcome Measures:
  • Pain scores [ Time Frame: First 4 postoperative days ] [ Designated as safety issue: No ]
    Measured on the NRS (defined above) during the first 4 postoperative days

  • Opioid Requirements [ Time Frame: First 4 postoperative days ] [ Designated as safety issue: No ]
    Both in and out of the hospital during the first 3 postoperative days

  • Opioid-related side effects [ Time Frame: First 4 postoperative days ] [ Designated as safety issue: No ]
    Both in and out of the hospital during the first 4 postoperative days

  • Sleep Disturbances [ Time Frame: First 4 postoperative days ] [ Designated as safety issue: No ]
    Due to breast pain during the first 4 postoperative days

  • Cancer Recurrence [ Time Frame: One Year following Surgery ] [ Designated as safety issue: No ]
    Patients' records will be investigated for indications of cancer recurrence up to 3 years following catheter placement (including estrogen receptor status as + or -). Patients may be contacted by phone if records suggest that the patient has not returned to the original surgeon within the previous 12 months

  • Pain and Physical Functioning [ Time Frame: Within first year of surgery ] [ Designated as safety issue: No ]
    Brief Pain Inventory given by phone on postop day 1, 4, 8; and weeks 4, 12; and months 3 and 12


Estimated Enrollment: 60
Study Start Date: October 2010
Estimated Study Completion Date: November 2015
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Infusion
Patients will be randomized to receive a continuous infusion of Normal Saline via a Paravertebral Nerve Block.
Procedure: Placebo (normal saline) Continuous Infusion
Patients randomized to this group will receive an initial catheter placement using the standard Ultrasound-guided Technique. For the surgical procedure they will receive 15cc of 0.5%Ropivicaine. Following the surgical procedure they will receive a pain pump filled with normal saline. The normal saline infusion will continue for the 3 days following surgery. All patients will have access to other pain relievers for break-through pain. All patients will have the outcome measures assessed.
Active Comparator: Ropivicaine 0.4% Infusion
Patients will be randomized to receive a continuous infusion of 0.4% Ropivicaine via a Paravertebral Nerve Block.
Procedure: Ropivicaine 0.4% Continuous Infusion
Patients randomized to this group will receive an initial catheter placement using the standard Ultrasound-guided Technique. For the surgical procedure they will receive 15cc of 0.5%Ropivicaine. Following the surgical procedure they will receive a pain pump filled with 0.4%Ropivicaine. The 0.4%Ropivicaine infusion will continue for the 3 days following surgery. All patients will have access to other pain relievers for break-through pain. All patients will have the outcome measures assessed.

Detailed Description:

Specific Aim 1: To determine if, compared with current and customary analgesia, the addition of a multiple-day ambulatory continuous paravertebral block decreases the incidence and severity of post-mastectomy pain.

Hypothesis 1: Following mastectomy, the incidence and severity of breast pain will be significantly decreased in the week following surgery with a multiple-day ambulatory continuous paravertebral block as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).

Hypothesis 2: Following mastectomy, the incidence and severity of chronic pain will be significantly decreased three months following multiple-day ambulatory continuous paravertebral blocks as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • undergoing unilateral or bilateral mastectomy
  • desiring analgesia with a paravertebral nerve block(s)
  • age 18 years or older
  • female

Exclusion Criteria:

  • morbid obesity as defined by a body mass index > 40
  • renal insufficiency
  • chronic opioid use
  • history of opioid abuse
  • any comorbidity which results in moderate or severe functional limitation
  • inability to communicate with the investigators or hospital staff
  • pregnancy
  • incarceration
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01231204

Locations
United States, California
UCSD Thornton Hospital
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Brian M Ilfeld, M.D., M.S. University of California, San Diego, Department of Anesthesia
  More Information

No publications provided

Responsible Party: Brian M. Ilfeld, MD, MS, Associate Professor, In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01231204     History of Changes
Other Study ID Numbers: PVB Catheter Study
Study First Received: October 27, 2010
Last Updated: November 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Breast Cancer
Mastectomy
UCSD
Surgery
PVB Catheter
Paravertebral Catheter
Breast Pain
Mastectomy Pain
Postoperative Pain

Additional relevant MeSH terms:
Breast Neoplasms
Mastodynia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014