A Phase 4 interventional study of Exparel and Marcaine in Urinary Tract Diseases, sponsored by Loma Linda University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-24.
Sponsored by Loma Linda University · Phase 4, Interventional, and Treatment
A prospective, randomized controlled study to determine the efficacy of liposomal bupivacaine given by local injection at all the wound sites in patients undergoing urologic surgeries.
A prospective, randomized controlled study to determine the efficacy of liposomal bupivacaine given by local injection at all the wound sites in patients undergoing urologic surgeries. Subjects of prospective study will be randomly divided using electronic program into two groups:
The first group will receive intraoperative local Liposomal Bupivacaine injection at the port placement site. The control group will receive will local Marcaine (bupivacaine HCl) injection
Primary Outcome Measures:
193 studies on the registry are indexed under Urologic Diseases; 51 are open to participants now.
This study's enrollment of 136 is above the median of 80 across 135 interventional studies indexed under Urologic Diseases.
Browse Urologic Diseases studies →Loma Linda University is the lead sponsor of 297 studies on the registry; 48 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 23 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site.
Drug: Exparel
This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site.
Drug: Marcaine
This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.
Also known as: liposomal bupivacaine
This group will receive intraoperative Bupivacaine HCl injection at the surgical site.
Also known as: Bupivacaine HCl
Total Opioid Consumption
Postoperative analgesic use will be measured in oral morphine equivalents dose given to patients in the first three days postoperatively
Time frame: Postoperative days 1-3
Postoperative Pain Assessment
Pain score (0-10) will be used. This will be based on a standard visual analog scale, where 0 indicates no pain and 10 indicates the most severe pain reported by patients.
Time frame: Postoperative day 1
Length of Hospital Stay
Duration of hospital stay after the surgery until time of discharge
Time frame: Duration of stay in hours
Postoperative Complications
Any complication related to the surgery within 30 days
Time frame: 30 days postoperatively
| Milestone | Exparel | Marcaine |
|---|---|---|
| Started | 63 | 73 |
| Completed | 63 | 73 |
| Not completed | 0 | 0 |
Postoperative analgesic use will be measured in oral morphine equivalents dose given to patients in the first three days postoperatively
| morphine equivalent | Exparel | Marcaine |
|---|---|---|
| Total Opioid Consumption | 16.4 ± 19.4 | 15.3 ± 16.2 |
Pain score (0-10) will be used. This will be based on a standard visual analog scale, where 0 indicates no pain and 10 indicates the most severe pain reported by patients.
| units on a scale | Exparel | Marcaine |
|---|---|---|
| Postoperative Pain Assessment | 4.6 ± 2.1 | 4.6 ± 2.4 |
Duration of hospital stay after the surgery until time of discharge
| Hours | Exparel | Marcaine |
|---|---|---|
| Length of Hospital Stay | 37 ± 31.8 | 36 ± 24 |
Any complication related to the surgery within 30 days
| Participants | Exparel | Marcaine |
|---|---|---|
| Postoperative Complications | 6 | 6 |
Collected over 30-days postoperatively. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Exparel | 0/63 (0%) | 6/63 (9.5%) | 0/63 (0%) |
| Marcaine | 0/73 (0%) | 6/73 (8.2%) | 0/73 (0%) |
| Event | Exparel | Marcaine |
|---|---|---|
| Postoperative IleusGastrointestinal disorders | 4/63 | 4/73 |
| Postoperative BleedingSurgical and medical procedures | 1/63 | 0/73 |
| Postoperative HypotensionSurgical and medical procedures | 1/63 | 1/73 |
| StrictureRenal and urinary disorders | 0/63 | 1/73 |
| Age, Categorical(Participants) | Exparel | Marcaine | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 30 | 38 | 68 |
| >=65 years | 33 | 35 | 68 |
| Age, Continuous(years) | Exparel | Marcaine | Total |
|---|---|---|---|
| Mean | 61.6 ± 12.3 | 62.7 ± 10.7 | 62.2 ± 11.4 |
| Sex: Female, Male(Participants) | Exparel | Marcaine | Total |
|---|---|---|---|
| Female | 40 | 48 | 88 |
| Male | 23 | 25 | 48 |
| Race (NIH/OMB)(Participants) | Exparel | Marcaine | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 63 | 73 | 136 |
| Region of Enrollment(participants) | Exparel | Marcaine | Total |
|---|---|---|---|
| United States | 63 | 73 | 136 |
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