Breast Cancer, Mastectomy, Paravertebral Catheter Insertion
Conditions
Keywords
Breast Cancer, Mastectomy, UCSD, Surgery, PVB Catheter, Paravertebral Catheter, Breast Pain, Mastectomy Pain, Postoperative Pain
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 description
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).
Interventions
PROCEDUREPlacebo (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.
PROCEDURERopivicaine 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.
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores (NRS) | Day following Surgery | Pain score on the 0-10 Numeric Rating Scale given as part of the Brief Pain Inventory |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Requirements | First 4 postoperative days | Both in and out of the hospital during the first 3 postoperative days |
| Opioid-related side effects | First 4 postoperative days | Both in and out of the hospital during the first 4 postoperative days |
| Pain scores | First 4 postoperative days | Measured on the NRS (defined above) during the first 4 postoperative days |
| Cancer Recurrence | 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 | 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 |
| Sleep Disturbances | First 4 postoperative days | Due to breast pain during the first 4 postoperative days |
Countries
United States
Outcome results
None listed