A Phase 4 interventional study of Exparel and Ropivacaine in Colorectal Surgery and TAP Blocks, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-04-27.
Sponsored by University of California, Davis · Phase 4, Interventional, and Treatment
This is a prospective randomized study designed to compare the pain control from a single shot of liposomal bupivacaine (Exparel) against transversus abominus plane (TAP) catheters with ropivicaine bolus in patients undergoing elective colorectal surgery.
At UC Davis, it is standard practice to place TAP blocks with catheters for adult colorectal surgery patients for perioperative pain control. This practice, however, is resource intensive, adds the risk of catheter-related complications, and adds increased burden to patients by requiring them to be tethered to 2 catheters.
An alternative TAP can be performed using a single shot of liposomal bupivacaine (Exparel), an extended release local anesthetic that is FDA-approved for surgical plane infiltration including TAP blocks.
With this prospective study, we seek to improve patient care at UC Davis and educate other institutions through the use of concrete data comparing these 2 treatment options.
University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single injection of Exparel
Drug: Exparel
Injection of Ropivicaine (Naropin) bolus and placement of Ropivicaine catheters
Drug: Ropivacaine
Patients will receive an injection of 30ml of volume to each abdominal side with a total of 60 ml for bilateral TAP blocks.
Also known as: Bupivacaine liposome injectable suspension
Patients will receive 30ml of ropivicaine. Peripheral nerve catheters will be placed approximately 3-5cm into the TAP space and secured to the skin with tegaderm tape. Infusions will be ordered with CADD pumps and will be initiated at a rate of 8ml/hr of 0.2% ropivicaine on the inpatient floor.
Also known as: Naropin
Mean Opioid Consumption in Morphine Opioid Equivalents in mg
Anticipate superior efficacy and pain control with liposomal bupivacaine TAP blocks measured by use of opioids (measured in oral morphine equivalents) in the first 48 hours following surgery Will use opioid consumption in morphine equivalents as a comparison
Time frame: 48 hours from start of surgery
| Milestone | Liposomal Bupivacaine Group | Ropivacaine Catheter Group |
|---|---|---|
| Started | 42 | 44 |
| Completed | 42 | 44 |
| Not completed | 0 | 0 |
Anticipate superior efficacy and pain control with liposomal bupivacaine TAP blocks measured by use of opioids (measured in oral morphine equivalents) in the first 48 hours following surgery Will use opioid consumption in morphine equivalents as a comparison
| IV morphine equivalents (mg) | Group 1 | Group 2 |
|---|---|---|
| Mean Opioid Consumption in Morphine Opioid Equivalents in mg | 112.12 ± 112.8 | 97.95 ± 58.15 |
Collected over From study enrollment in the preoperative holding area for 2 hospital days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Group 2 | 0/44 (0%) | 0/44 (0%) | 0/44 (0%) |
| Age, Continuous(years) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Mean | 57.4 (19 to 79) | 57.1 (19 to 80) | 57.2 (19 to 80) |
| Sex: Female, Male(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Female | 21 | 24 | 45 |
| Male | 21 | 20 | 41 |
| Race and Ethnicity Not Collected(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| United States | 42 | 44 | 86 |
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Plan to share: No
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University of California, Davis