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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Mastectomy; Paravertebral Catheter Insertion
• Intervention / Treatment: Procedure: Placebo (normal saline) Continuous Infusion; Procedure: Ropivicaine 0.4% Continuous Infusion

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).

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • UCSD Thornton Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores (NRS)	Pain score on the 0-10 Numeric Rating Scale given as part of the Brief Pain Inventory	Day following Surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	Measured on the NRS (defined above) during the first 4 postoperative days	First 4 postoperative days
Opioid Requirements	Both in and out of the hospital during the first 3 postoperative days	First 4 postoperative days
Opioid-related side effects	Both in and out of the hospital during the first 4 postoperative days	First 4 postoperative days
Sleep Disturbances	Due to breast pain during the first 4 postoperative days	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	One Year following Surgery
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	Within first year of surgery

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Brian M Ilfeld, M.D., M.S., University of California, San Diego, Department of Anesthesia

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: October 27, 2010
• First Submitted That Met QC Criteria: October 29, 2010
• First Posted (Estimate): November 1, 2010

Study Record Updates

• Last Update Posted (Estimate): April 11, 2016
• Last Update Submitted That Met QC Criteria: April 7, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Postoperative Pain; Breast Cancer; Surgery; Mastectomy; Paravertebral Catheter; UCSD; PVB Catheter; Breast Pain; Mastectomy Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mastodynia
• Other Study ID Numbers: PVB Catheter Study