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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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).


Sponsor: University of California, San Diego

Current Primary Outcome: Pain Scores (NRS) [ Time Frame: Day following Surgery ]

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


Original Primary Outcome:

  • Pain and Physical Functioning [ Time Frame: Day of Surgery ]
    Brief Pain Inventory (includes the 11-point NRS of pain intensity)
  • Pain and Physical Functioning [ Time Frame: 3 Days following surgery ]
    Brief Pain Inventory (includes the 11-point NRS of pain intensity)


Current Secondary Outcome:

  • Pain scores [ Time Frame: First 4 postoperative days ]
    Measured on the NRS (defined above) during the first 4 postoperative days
  • Opioid Requirements [ Time Frame: First 4 postoperative days ]
    Both in and out of the hospital during the first 3 postoperative days
  • Opioid-related side effects [ Time Frame: First 4 postoperative days ]
    Both in and out of the hospital during the first 4 postoperative days
  • Sleep Disturbances [ Time Frame: First 4 postoperative days ]
    Due to breast pain during the first 4 postoperative days
  • Cancer Recurrence [ Time Frame: One Year following Surgery ]
    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 ]
    Brief Pain Inventory given by phone on postop day 1, 4, 8; and weeks 4, 12; and months 3 and 12


Original Secondary Outcome:

  • Pain scores [ Time Frame: Day of Surgery ]
    Measured on the NRS (defined above) during the first 3 postoperative days
  • Opioid Requirements [ Time Frame: Day of Surgery ]
    Both in and out of the hospital during the first 3 postoperative days
  • Opioid-related side effects [ Time Frame: Day of Surgery ]
    Both in and out of the hospital during the first 3 postoperative days
  • Sleep Disturbances [ Time Frame: Day of Surgery ]
    Due to breast pain during the first 3 postoperative days
  • Cancer Recurrence [ Time Frame: One Year following Surgery ]
    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 ]
    Measured on the NRS (defined above) during the first 3 postoperative days
  • Opioid Requirements [ Time Frame: 3 days following surgery ]
    Both in and out of the hospital during the first 3 postoperative days
  • Opioid-related side effects [ Time Frame: 3 days following surgery ]
    Both in and out of the hospital during the first 3 postoperative days
  • Sleep Disturbances [ Time Frame: 3 days following surgery ]
    Due to breast pain during the first 3 postoperative days
  • Cancer Recurrence [ Time Frame: 3 years following surgery ]
    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


Information By: University of California, San Diego

Dates:
Date Received: October 27, 2010
Date Started: October 2010
Date Completion:
Last Updated: April 7, 2016
Last Verified: April 2016