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Aim: To compare the postoperative outcomes after surgical infiltration with plain bupivacaine compared to liposomal bupivacaine in patients undergoing elective, minimally invasive, general surgery procedures. To the investigators knowledge, there are no head-to-head, prospective, randomized, controlled trials of plain bupivacaine versus liposomal bupivacaine to evaluate postoperative pain and return of function.
The investigators current standard has been to use liposomal bupivacaine routinely for surgical infiltration which was a change from the historical practice of infiltration with lidocaine/bupivacaine, plain bupivacaine or no local anesthetic at all. The change was made due to the perceived benefits in analgesia past the 12-24 hours that plain bupivacaine was effective. It is not clear, however, that there are statistically significant benefits in terms of reduced narcotic use and length of hospital stay and improved pain control and return of function post-operatively.
Primary outcomes: The investigators will then measure narcotic use post-operatively as calculated by combining measures of patient-controlled analgesia (PCA) use for first 24 hours added to in-patient oral narcotic use (by referencing the electronic medical record (EMR)) as well as out-patient oral narcotic use as reported by patients. Subjective pain levels and pain interference scale and physical functioning scale will be evaluated pre-operatively and post-operatively with use of the Pain Assessment Screening Tool and Outcomes Registry (PASTOR) developed by the Defense and Veterans Center for Integrative Pain Management (DVCIPM) as a measure of perioperative pain and function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivicaine arm | Experimental | Post procedure, infiltrate wounds with liposomal bupivacaine
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| Plain Bupivicaine | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liposomal bupivicaine | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Total post operative narcotic use in morphine equivalents. | To be measured by combining measures of Patient-Controlled Analgesia pump use for the first 24 hours added to in-patient oral narcotic use (by referencing the electronic medical record (EMR) and out-patient oral narcotic use as reported by patients. | Up to fourteen days. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay post operative procedure. | Participants post operative procedure length of stay will be determined from the electronic medical record. | up to fourteen days. |
| Pain level pre and post operative procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David P Gallus, MD | United States Naval Medical Center, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center San Diego | San Diego | California | 92134 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Baseline pain level will be gathered pre operative procedure and post operative procedure day one, seven, and fourteen through the 0 to 10 pain scale with 0 being "No Pain", 5 being "Moderate Pain", and 10 being "Worse Possible Pain".
| Up to fourteen days. |
| Post operative procedure physical functioning level. | Data is gathered on POP day one, seven and fourteen through the Physical Functioning Scale (PFS), which is scored from 0 to 100 with a higher scores indicating better physical function. | Up to fourteen days. |
| Number of post operative procedure adverse events. | Data is gathered from the patient electronic medical record (EMR). | Up to fourteen days. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |