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

NCT ID: NCT01231204

Last Updated: 2016-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2016-03-31

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).

Conditions

Paravertebral Catheter Insertion; Mastectomy; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo Infusion

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

Group Type: PLACEBO_COMPARATOR

Placebo (normal saline) Continuous Infusion

Intervention Type: PROCEDURE

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.

Ropivicaine 0.4% Infusion

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

Group Type: ACTIVE_COMPARATOR

Ropivicaine 0.4% Continuous Infusion

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Brian M. Ilfeld, MD, MS

Associate Professor, In Residence

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian M Ilfeld, M.D., M.S.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego, Department of Anesthesia

Locations

UCSD Thornton Hospital

La Jolla, California, United States

Countries

United States

Other Identifiers

PVB Catheter Study

Identifier Type: -

Identifier Source: org_study_id