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

NCT01231204 | Completed Phase 4

• 1 other identifier: PVB Catheter Study
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Paravertebral Catheter Insertion; Mastectomy; Breast Cancer

Keywords

Breast Cancer; Mastectomy; UCSD; Surgery; PVB Catheter; Paravertebral Catheter; Breast Pain; Mastectomy Pain; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Pain Scores (NRS)

  Pain score on the 0-10 Numeric Rating Scale given as part of the Brief Pain Inventory

  Day following Surgery

Secondary Outcomes (6)

• Pain scores

  First 4 postoperative days

• Opioid Requirements

  First 4 postoperative days

• Opioid-related side effects

  First 4 postoperative days

• Sleep Disturbances

  First 4 postoperative days

• Cancer Recurrence

  One Year following Surgery

Study Arms (2)

Placebo Infusion

PLACEBO COMPARATOR

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

Procedure: Placebo (normal saline) Continuous Infusion

Ropivicaine 0.4% Infusion

ACTIVE COMPARATOR

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

Procedure: Ropivicaine 0.4% Continuous Infusion

Interventions

Placebo (normal saline) Continuous Infusion 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.

Placebo Infusion

Ropivicaine 0.4% Continuous Infusion 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.

Ropivicaine 0.4% Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing unilateral or bilateral mastectomy
• desiring analgesia with a paravertebral nerve block(s)
• age 18 years or older
• female

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Thornton Hospital

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Mastodynia; Pain, Postoperative

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Brian M Ilfeld, M.D., M.S.

  University of California, San Diego, Department of Anesthesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, In Residence

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: November 1, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: March 1, 2016
• Last Updated: April 11, 2016

Record last verified: 2016-04

Locations

US (1)