Modified TAP (Transverse Abdominis Plane) Block in Colorectal Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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TAP (Transverse Abdominis Plane) Block With Exparel (Liposomal Bupivicaine) vs. Bupivicaine Post-op Pain Management

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Other: Pain Scale
* Drug: Exparel Injectable Product
* Drug: Bupivacaine Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age 18-75 years undergoing planned laparoscopic colon or rectal resection Exclusion Criteria: Patients younger than 18 or older than 75 years old Pregnant women Patients who have taken steroids or other immunomodulators within the last 6 months Patients on home narcotics Patients allergic to Exparel or bupivacaine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP Block with Exparel<br>TAP Block with 20 mL (266mg) of liposomal bupivacaine with 25 mL (5 mg/mL) of bupivacaine diluted in 55 mL of normal saline | Other: Pain Scale<br>* Maximum Daily Pain Scale will be recorded daily until discharge (typically under 7 days)<br>Drug: Exparel Injectable Product<br>* Given at the beginning of the surgery for post-operative pain management<br>|
| Active Comparator: TAP Block with bupivicaine<br>TAP Block with 30 mL (5mg/mL) of bupivacaine diluted in 70 mL of normal saline | Other: Pain Scale<br>* Maximum Daily Pain Scale will be recorded daily until discharge (typically under 7 days)<br>Drug: Bupivacaine Injection<br>* Given at the beginning of the surgery for post-operative pain management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | daily through study completion (up to 30 days) |