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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Paravertebral Catheter Insertion, Mastectomy, Breast Cancer

Intervention / Treatment
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* Procedure: Placebo (normal saline) Continuous Infusion
* Procedure: Ropivicaine 0.4% Continuous Infusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Infusion<br>Patients will be randomized to receive a continuous infusion of Normal Saline via a Paravertebral Nerve Block. | Procedure: Placebo (normal saline) Continuous Infusion<br>* 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.<br>|
| Active Comparator: Ropivicaine 0.4% Infusion<br>Patients will be randomized to receive a continuous infusion of 0.4% Ropivicaine via a Paravertebral Nerve Block. | Procedure: Ropivicaine 0.4% Continuous Infusion<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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UCSD, Breast Cancer, Mastectomy, Surgery, PVB Catheter, Paravertebral Catheter, Breast Pain, Mastectomy Pain, Postoperative Pain