Urinary Tract Diseases
Conditions
Keywords
Bupivacaine, Minimally Invasive Surgical Procedures
Brief summary
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.
Detailed description
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: * Total opioid consumption measured in intravenous morphine equivalents dose during the postoperative hospital Stay * Postoperative pain assessment using visual Analog Pain Scores & Brief Pain Inventory form. * Length of Hospital Stay * Time to First Opioid Use. * Postoperative Constipation , paralytic ileus
Interventions
DRUGExparel
This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.
DRUGMarcaine
This group will receive intraoperative Bupivacaine HCl injection at the surgical site.
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing urologic surgery.
Exclusion criteria
* Pregnant and/or nursing mothers. * Allergy to bupivacaine. * History of drug/alcohol abuse. * Severe cardiovascular, hepatic, renal disease or neurological impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Consumption | Postoperative days 1-3 | Postoperative analgesic use will be measured in oral morphine equivalents dose given to patients in the first three days postoperatively |
| Postoperative Pain Assessment | Postoperative day 1 | 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. |
| Length of Hospital Stay | Duration of stay in hours | Duration of hospital stay after the surgery until time of discharge |
| Postoperative Complications | 30 days postoperatively | Any complication related to the surgery within 30 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exparel This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site.
Exparel: This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site. | 63 |
| Marcaine This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site.
Marcaine: This group will receive intraoperative Bupivacaine HCl injection at the surgical site. | 73 |
| Total | 136 |
Baseline characteristics
| Characteristic | Marcaine | Total | Exparel |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 35 Participants | 68 Participants | 33 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants | 68 Participants | 30 Participants |
| Age, Continuous | 62.7 years STANDARD_DEVIATION 10.7 | 62.2 years STANDARD_DEVIATION 11.4 | 61.6 years STANDARD_DEVIATION 12.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 73 Participants | 136 Participants | 63 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 73 participants | 136 participants | 63 participants |
| Sex: Female, Male Female | 48 Participants | 88 Participants | 40 Participants |
| Sex: Female, Male Male | 25 Participants | 48 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 73 |
| other Total, other adverse events | 0 / 63 | 0 / 73 |
| serious Total, serious adverse events | 6 / 63 | 6 / 73 |
Outcome results
Primary
Length of Hospital Stay
Duration of hospital stay after the surgery until time of discharge
Time frame: Duration of stay in hours
Population: During an audit by the compliance department of Loma Linda University, it was noted that some consents were incomplete and therefore could not undergo further analysis. Data presented has been taken from abstracts with preliminary analyses presented prior to the audit and subsequently should be interpreted with caution.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exparel | Length of Hospital Stay | 37 Hours | Standard Deviation 31.8 |
| Marcaine | Length of Hospital Stay | 36 Hours | Standard Deviation 24 |
Primary
Postoperative Complications
Any complication related to the surgery within 30 days
Time frame: 30 days postoperatively
Population: During an audit by the compliance department of Loma Linda University, it was noted that some consents were incomplete and therefore could not undergo further analysis. Data presented has been taken from abstracts with preliminary analyses presented prior to the audit and subsequently should be interpreted with caution.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exparel | Postoperative Complications | 6 Participants |
| Marcaine | Postoperative Complications | 6 Participants |
Primary
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
Population: During an audit by the compliance department of Loma Linda University, it was noted that some consents were incomplete and therefore could not undergo further analysis. Data presented has been taken from abstracts with preliminary analyses presented prior to the audit and subsequently should be interpreted with caution.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exparel | Postoperative Pain Assessment | 4.6 units on a scale | Standard Deviation 2.1 |
| Marcaine | Postoperative Pain Assessment | 4.6 units on a scale | Standard Deviation 2.4 |
Primary
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
Population: During an audit by the compliance department of Loma Linda University, it was noted that some consents were incomplete and therefore could not undergo further analysis. Data presented has been taken from abstracts with preliminary analyses presented prior to the audit and subsequently should be interpreted with caution.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exparel | Total Opioid Consumption | 16.4 morphine equivalent | Standard Deviation 19.4 |
| Marcaine | Total Opioid Consumption | 15.3 morphine equivalent | Standard Deviation 16.2 |