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Single Blind, Randomized Controlled study to see if TAP Block with Exparel provides better pain relief than TAP Block with bupivicaine. Differences in Pain Scale, Length of Stay, and Total Narcotic use in the hospital will be evaluated.
Subjects recruited into the study will undergo surgery as scheduled. During the procedure they will receive a TAP Block with one of the pain medications. TAP Block in the experimental arm will be performed with 20 mL (266mg) of liposomal bupivacaine with 25 mL (5 mg/mL) of bupivacaine diluted in 55 mL of normal saline. The control arm will have a TAP Block performed with 30 mL (5mg/mL) of bupivacaine diluted in 70 mL of normal saline. These doses are consistent with prior studies of TAP Block with liposomal bupivacaine. Subjects will be monitored for pain as per standard of care and will be given pain medication as needed.
Subject Recruitment and Screening Patients will be recruited from the Ochsner Colorectal Surgery Clinic at the time of a preoperative visit.
Study Procedures
Screening & Baseline Visit After obtaining informed consent the subjects relevant medical and surgical history will be documented. Demographics and vitals will be documented. Current use of pain medication will be recorded. A physical exam will be performed.
Day of Surgery Routine vital signs will be obtained preoperatively. During the operation subject will receive a TAP Block containing their randomized local injection mixture as described above. Following surgery the subject will recover the PACU and pain medication will be provided on demand. Initial postoperative vital signs and pain scores will be obtained at this time.
Post-Operative Course Postoperatively subject will have regularly scheduled vital signs and pain scores obtained, and recorded for study use. Narcotic and non-narcotic pain medication will be provided on demand; dosages will be recorded for study use. Subjects will be followed until they are discharged at which time study participation will be complete.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAP Block with Exparel | Experimental | TAP Block with 20 mL (266mg) of liposomal bupivacaine with 25 mL (5 mg/mL) of bupivacaine diluted in 55 mL of normal saline |
|
| TAP Block with bupivicaine | Active Comparator | TAP Block with 30 mL (5mg/mL) of bupivacaine diluted in 70 mL of normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain Scale | Other | Maximum Daily Pain Scale will be recorded daily until discharge (typically under 7 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scale | Daily Pain Scale using Wong-baker FACES Pain Rating Scale 0 (no pain) - 10 (worst pain imaginable) | daily through study completion (up to 30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | Duration of hospitalization post-operatively | daily through study completion (up to 30 days) |
| Narcotic use | Total amount of narcotic used for pain control postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Whitlow, MD | Ochsner | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35849756 | Derived | Chevrollier GS, Klinger AL, Green HJ, Gastanaduy MM, Johnston WF, Vargas HD, Kann BR, Whitlow CB, Paruch JL. Liposomal Bupivacaine Transversus Abdominis Plane Blocks in Laparoscopic Colorectal Resections: A Single-Institution Randomized Controlled Trial. Dis Colon Rectum. 2023 Feb 1;66(2):322-330. doi: 10.1097/DCR.0000000000002346. Epub 2022 May 24. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 28, 2023 | Apr 19, 2023 | 3 |
| 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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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Exparel Injectable Product | Drug | Given at the beginning of the surgery for post-operative pain management |
|
| Bupivacaine Injection | Drug | Given at the beginning of the surgery for post-operative pain management |
|
| daily through study completion (up to 30 days) |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |