Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks
Primary Purpose
Paravertebral Catheter Insertion, Mastectomy, Breast Cancer
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Placebo (normal saline) Continuous Infusion
Ropivicaine 0.4% Continuous Infusion
Sponsored by
About this trial
This is an interventional treatment trial for Paravertebral Catheter Insertion focused on measuring Breast Cancer, Mastectomy, UCSD, Surgery, PVB Catheter, Paravertebral Catheter, Breast Pain, Mastectomy Pain, Postoperative Pain
Eligibility 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
Sites / Locations
- UCSD Thornton Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo Infusion
Ropivicaine 0.4% Infusion
Arm Description
Patients will be randomized to receive a continuous infusion of Normal Saline via a Paravertebral Nerve Block.
Patients will be randomized to receive a continuous infusion of 0.4% Ropivicaine via a Paravertebral Nerve Block.
Outcomes
Primary Outcome Measures
Pain Scores (NRS)
Pain score on the 0-10 Numeric Rating Scale given as part of the Brief Pain Inventory
Secondary Outcome Measures
Pain scores
Measured on the NRS (defined above) during the first 4 postoperative days
Opioid Requirements
Both in and out of the hospital during the first 3 postoperative days
Opioid-related side effects
Both in and out of the hospital during the first 4 postoperative days
Sleep Disturbances
Due to breast pain during the first 4 postoperative days
Cancer Recurrence
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
Brief Pain Inventory given by phone on postop day 1, 4, 8; and weeks 4, 12; and months 3 and 12
Full Information
NCT ID
NCT01231204
First Posted
October 27, 2010
Last Updated
April 7, 2016
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT01231204
Brief Title
Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks
Official Title
Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paravertebral Catheter Insertion, Mastectomy, Breast Cancer
Keywords
Breast Cancer, Mastectomy, UCSD, Surgery, PVB Catheter, Paravertebral Catheter, Breast Pain, Mastectomy Pain, Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo Infusion
Arm Type
Placebo Comparator
Arm Description
Patients will be randomized to receive a continuous infusion of Normal Saline via a Paravertebral Nerve Block.
Arm Title
Ropivicaine 0.4% Infusion
Arm Type
Active Comparator
Arm Description
Patients will be randomized to receive a continuous infusion of 0.4% Ropivicaine via a Paravertebral Nerve Block.
Intervention Type
Procedure
Intervention Name(s)
Placebo (normal saline) Continuous Infusion
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ropivicaine 0.4% Continuous Infusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Scores (NRS)
Description
Pain score on the 0-10 Numeric Rating Scale given as part of the Brief Pain Inventory
Time Frame
Day following Surgery
Secondary Outcome Measure Information:
Title
Pain scores
Description
Measured on the NRS (defined above) during the first 4 postoperative days
Time Frame
First 4 postoperative days
Title
Opioid Requirements
Description
Both in and out of the hospital during the first 3 postoperative days
Time Frame
First 4 postoperative days
Title
Opioid-related side effects
Description
Both in and out of the hospital during the first 4 postoperative days
Time Frame
First 4 postoperative days
Title
Sleep Disturbances
Description
Due to breast pain during the first 4 postoperative days
Time Frame
First 4 postoperative days
Title
Cancer Recurrence
Description
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
Time Frame
One Year following Surgery
Title
Pain and Physical Functioning
Description
Brief Pain Inventory given by phone on postop day 1, 4, 8; and weeks 4, 12; and months 3 and 12
Time Frame
Within first year of surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian M Ilfeld, M.D., M.S.
Organizational Affiliation
University of California, San Diego, Department of Anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Thornton Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks
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