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 ]
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