Overview

This trial is active, not recruiting.

Conditions paravertebral catheter insertion, mastectomy, breast cancer
Treatments placebo (normal saline) continuous infusion, ropivicaine 0.4% continuous infusion
Phase phase 4
Sponsor University of California, San Diego
Start date October 2010
End date November 2012
Trial size 60 participants
Trial identifier NCT01231204, PVB Catheter Study

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Patients will be randomized to receive a continuous infusion of Normal Saline via a Paravertebral Nerve Block.
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)
Patients will be randomized to receive a continuous infusion of 0.4% Ropivicaine via a Paravertebral Nerve Block.
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.

Primary Outcomes

Measure
Pain Scores (NRS)
time frame: Day following Surgery

Secondary Outcomes

Measure
Pain scores
time frame: First 4 postoperative days
Opioid Requirements
time frame: First 4 postoperative days
Opioid-related side effects
time frame: First 4 postoperative days
Sleep Disturbances
time frame: First 4 postoperative days
Cancer Recurrence
time frame: One Year following Surgery
Pain and Physical Functioning
time frame: Within first year of surgery

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks
Principal investigator Brian M Ilfeld, M.D., M.S.
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).
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by University of California, San Diego.