Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cosmetic |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2010 |
| End Date: | March 2016 |
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.
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).
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
We found this trial at
1
site
Click here to add this to my saved trials
