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
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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2014