Pain, Postoperative
Conditions
Brief summary
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
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.
Interventions
OTHERPain Scale
Maximum Daily Pain Scale will be recorded daily until discharge (typically under 7 days)
Given at the beginning of the surgery for post-operative pain management
DRUGBupivacaine Injection
Given at the beginning of the surgery for post-operative pain management
Sponsors
Ochsner Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients age 18-75 years undergoing planned laparoscopic colon or rectal resection
Exclusion criteria
1. Patients younger than 18 or older than 75 years old 2. Pregnant women 3. Patients who have taken steroids or other immunomodulators within the last 6 months 4. Patients on home narcotics 5. Patients allergic to Exparel or bupivacaine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scale | daily through study completion (up to 30 days) | Daily Pain Scale using Wong-baker FACES Pain Rating Scale 0 (no pain) - 10 (worst pain imaginable) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | daily through study completion (up to 30 days) | Duration of hospitalization post-operatively |
| Narcotic use | daily through study completion (up to 30 days) | Total amount of narcotic used for pain control postoperatively |
Countries
United States
Outcome results
None listed