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

Phase 4

Completed

• Conditions: Breast Cancer; Paravertebral Catheter Insertion; Mastectomy
• Interventions: Procedure: Placebo (normal saline) Continuous Infusion; Procedure: Ropivicaine 0.4% Continuous Infusion

• Registration Number: NCT01231204
• Lead Sponsor: University of California, San Diego

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).

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-27
• Study First Submitted QC: 2010-10-29
• Study First Posted: 2010-11-01
• Primary Completion: 2012-11
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-07
• Last Update Posted: 2016-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Infusion	Placebo (normal saline) Continuous Infusion	Patients will be randomized to receive a continuous infusion of Normal Saline via a Paravertebral Nerve Block.
Ropivicaine 0.4% Infusion	Ropivicaine 0.4% Continuous Infusion	Patients will be randomized to receive a continuous infusion of 0.4% Ropivicaine via a Paravertebral Nerve Block.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Opioid-related side effects	First 4 postoperative days	Both in and out of the hospital during the first 4 postoperative days
Cancer Recurrence	One Year following Surgery	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	Within first year of surgery	Brief Pain Inventory given by phone on postop day 1, 4, 8; and weeks 4, 12; and months 3 and 12
Pain scores	First 4 postoperative days	Measured on the NRS (defined above) during the first 4 postoperative days
Opioid Requirements	First 4 postoperative days	Both in and out of the hospital during the first 3 postoperative days
Sleep Disturbances	First 4 postoperative days	Due to breast pain during the first 4 postoperative days

Trial Locations

Locations (1)

UCSD Thornton Hospital; 🇺🇸 La Jolla, California, United States