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

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Breast Diseases Cancer Mastectomy

U.S. FDA Resources

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.

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:	December 19, 2012
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 May 23, 2013