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

University of California San Diego

Status and phase: Completed; Phase 4

Conditions: Breast Cancer; Mastectomy; Paravertebral Catheter Insertion

Treatments: Procedure: Ropivicaine 0.4% Continuous Infusion; Procedure: Placebo (normal saline) Continuous Infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01231204

PVB Catheter Study

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Placebo Infusion

Placebo Comparator group

Description:

Patients will be randomized to receive a continuous infusion of Normal Saline via a Paravertebral Nerve Block.

Treatment:

Procedure: Placebo (normal saline) Continuous Infusion

Ropivicaine 0.4% Infusion

Active Comparator group

Description:

Patients will be randomized to receive a continuous infusion of 0.4% Ropivicaine via a Paravertebral Nerve Block.

Treatment:

Procedure: Ropivicaine 0.4% Continuous Infusion