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


Phase 4
18 Years
N/A
Open (Enrolling)
Female
Paravertebral Catheter Insertion, Mastectomy, Breast Cancer

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Trial Information

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


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).


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Pain Scores (NRS)

Outcome Description:

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

Outcome Time Frame:

Day following Surgery

Safety Issue:

No

Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Diego, Department of Anesthesia

Authority:

United States: Institutional Review Board

Study ID:

PVB Catheter Study

NCT ID:

NCT01231204

Start Date:

October 2010

Completion Date:

November 2015

Related Keywords:

  • Paravertebral Catheter Insertion
  • Mastectomy
  • Breast Cancer
  • Breast Cancer
  • Mastectomy
  • UCSD
  • Surgery
  • PVB Catheter
  • Paravertebral Catheter
  • Breast Pain
  • Mastectomy Pain
  • Postoperative Pain
  • Breast Neoplasms

Name

Location
UCSD Thornton Hospital La Jolla, California  92037