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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01231204
First received: October 27, 2010
Last updated: December 19, 2012
Last verified: December 2012
History of Changes

October 27, 2010
December 19, 2012
October 2010
November 2012   (final data collection date for primary outcome measure)
Pain Scores (NRS) [ Time Frame: Day following Surgery ] [ Designated as safety issue: No ]
Pain score on the 0-10 Numeric Rating Scale given as part of the Brief Pain Inventory
  • Pain and Physical Functioning [ Time Frame: Day of Surgery ] [ Designated as safety issue: No ]
    Brief Pain Inventory (includes the 11-point NRS of pain intensity)
  • Pain and Physical Functioning [ Time Frame: 3 Days following surgery ] [ Designated as safety issue: No ]
    Brief Pain Inventory (includes the 11-point NRS of pain intensity)
Complete list of historical versions of study NCT01231204 on ClinicalTrials.gov Archive Site
  • Pain scores [ Time Frame: First 4 postoperative days ] [ Designated as safety issue: No ]
    Measured on the NRS (defined above) during the first 4 postoperative days
  • Opioid Requirements [ Time Frame: First 4 postoperative days ] [ Designated as safety issue: No ]
    Both in and out of the hospital during the first 3 postoperative days
  • Opioid-related side effects [ Time Frame: First 4 postoperative days ] [ Designated as safety issue: No ]
    Both in and out of the hospital during the first 4 postoperative days
  • Sleep Disturbances [ Time Frame: First 4 postoperative days ] [ Designated as safety issue: No ]
    Due to breast pain during the first 4 postoperative days
  • Cancer Recurrence [ Time Frame: One Year following Surgery ] [ Designated as safety issue: No ]
    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
  • Pain and Physical Functioning [ Time Frame: Within first year of surgery ] [ Designated as safety issue: No ]
    Brief Pain Inventory given by phone on postop day 1, 4, 8; and weeks 4, 12; and months 3 and 12
  • Pain scores [ Time Frame: Day of Surgery ] [ Designated as safety issue: No ]
    Measured on the NRS (defined above) during the first 3 postoperative days
  • Opioid Requirements [ Time Frame: Day of Surgery ] [ Designated as safety issue: No ]
    Both in and out of the hospital during the first 3 postoperative days
  • Opioid-related side effects [ Time Frame: Day of Surgery ] [ Designated as safety issue: No ]
    Both in and out of the hospital during the first 3 postoperative days
  • Sleep Disturbances [ Time Frame: Day of Surgery ] [ Designated as safety issue: No ]
    Due to breast pain during the first 3 postoperative days
  • Cancer Recurrence [ Time Frame: One Year following Surgery ] [ Designated as safety issue: No ]
    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
  • Pain scores [ Time Frame: 3 days following surgery ] [ Designated as safety issue: No ]
    Measured on the NRS (defined above) during the first 3 postoperative days
  • Opioid Requirements [ Time Frame: 3 days following surgery ] [ Designated as safety issue: No ]
    Both in and out of the hospital during the first 3 postoperative days
  • Opioid-related side effects [ Time Frame: 3 days following surgery ] [ Designated as safety issue: No ]
    Both in and out of the hospital during the first 3 postoperative days
  • Sleep Disturbances [ Time Frame: 3 days following surgery ] [ Designated as safety issue: No ]
    Due to breast pain during the first 3 postoperative days
  • Cancer Recurrence [ Time Frame: 3 years following surgery ] [ Designated as safety issue: No ]
    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
Not Provided
Not Provided
 
Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks
Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks

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.

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).
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Paravertebral Catheter Insertion
  • Mastectomy
  • Breast Cancer
  • Procedure: 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.
  • 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.
  • Placebo Comparator: Placebo Infusion
    Patients will be randomized to receive a continuous infusion of Normal Saline via a Paravertebral Nerve Block.
    Intervention: Procedure: Placebo (normal saline) Continuous Infusion
  • Active Comparator: Ropivicaine 0.4% Infusion
    Patients will be randomized to receive a continuous infusion of 0.4% Ropivicaine via a Paravertebral Nerve Block.
    Intervention: Procedure: Ropivicaine 0.4% Continuous Infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
November 2015
November 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01231204
PVB Catheter Study
No
Brian M. Ilfeld, MD, MS, University of California, San Diego
University of California, San Diego
Not Provided
Principal Investigator: Brian M Ilfeld, M.D., M.S. University of California, San Diego, Department of Anesthesia
University of California, San Diego
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP