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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Infusion | Placebo Comparator | Patients will be randomized to receive a continuous infusion of Normal Saline via a Paravertebral Nerve Block. |
|
| Ropivicaine 0.4% Infusion | Active Comparator | Patients will be randomized to receive a continuous infusion of 0.4% Ropivicaine via a Paravertebral Nerve Block. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo (normal saline) Continuous Infusion | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores (NRS) | Pain score on the 0-10 Numeric Rating Scale given as part of the Brief Pain Inventory | Day following Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores | Measured on the NRS (defined above) during the first 4 postoperative days | First 4 postoperative days |
| Opioid Requirements | Both in and out of the hospital during the first 3 postoperative days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian M Ilfeld, M.D., M.S. | University of California, San Diego, Department of Anesthesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Thornton Hospital | La Jolla | California | 92093 | United States |
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| Ropivicaine 0.4% Continuous Infusion | Procedure | 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. |
|
| First 4 postoperative days |
| Opioid-related side effects | Both in and out of the hospital during the first 4 postoperative days | First 4 postoperative days |
| Sleep Disturbances | Due to breast pain during the first 4 postoperative days | First 4 postoperative days |
| Cancer Recurrence | 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 | One Year following Surgery |
| Pain and Physical Functioning | Brief Pain Inventory given by phone on postop day 1, 4, 8; and weeks 4, 12; and months 3 and 12 | Within first year of surgery |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D059373 | Mastodynia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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