Pain, Postoperative
Conditions
Keywords
Randomized controlled trial, anesthetics-local, bupivacaine, analgesia, Pain, Postoperative
Brief summary
A prospective, randomized comparison of bupivacaine to liposomal bupivacaine given by local injection at all the wound sites in patients undergoing robotic-assisted or laparoscopic urologic surgeries in an effort to determine which method reduced postoperative opioid use the most.
Detailed description
Liposomal bupivacaine was developed to extend the duration of efficacy of bupivacaine from the typical 6 - 8 hours up to 72 hours. The prolonged duration of liposomal bupivacaine was initially demonstrated in mice in 1994. Two randomized controlled trials using liposomal bupivacaine for bunionectomy and hemorrhoidectomy resulted in FDA approval for its use in humans. More recently, liposomal bupivacaine has also been found to improve pain control for patients undergoing total knee arthroplasty. Infiltration of a local anesthetic into laparoscopic port sites is a common practice that has been shown in some studies to improve postoperative pain. To compare liposomal bupivacaine and 0.25% bupivacaine for local analgesia following laparoscopic and robotic urologic surgery, a randomized comparison-controlled trial was performed.
Interventions
DRUGBupivacaine
DRUGliposomal bupivacaine
Sponsors
Knight, Richard, M.D.
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
* At least 18-years-old, undergoing laparoscopic urologic surgery.
Exclusion criteria
* Pregnant and/or nursing mothers. * Allergy to bupivacaine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Consumption Measured in Intravenous Morphine Equivalents During the Postoperative Hospital Stay | All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital. | Total opioid consumption measured in intravenous morphine equivalents during the postoperative hospital stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Pain Scores. | All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital. | Visual analog pain scores. |
| Length of Hospital Stay. | All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital. | Length of hospital stay. |
| Time to First Opioid Use. | All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital. | Time to first opioid use. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupivacaine Surgical site infiltration of 0.25% bupivacaine.
Bupivacaine | 94 |
| Liposomal Bupivacaine Surgical site infiltration of liposomal bupivacaine.
liposomal bupivacaine | 97 |
| Total | 191 |
Baseline characteristics
| Characteristic | Bupivacaine | Liposomal Bupivacaine | Total |
|---|---|---|---|
| Age, Customized Age | 63 years | 62 years | 63 years |
| BMI | 28.9 kg/m2 | 28.2 kg/m2 | 28.7 kg/m2 |
| Race/Ethnicity, Customized African American | 5 participants | 6 participants | 11 participants |
| Race/Ethnicity, Customized Asian/Pacific Islander | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Hispanic | 45 participants | 55 participants | 100 participants |
| Race/Ethnicity, Customized Unknown | 3 participants | 3 participants | 6 participants |
| Race/Ethnicity, Customized White | 41 participants | 32 participants | 73 participants |
| Region of Enrollment United States | 94 participants | 97 participants | 191 participants |
| Sex: Female, Male Female | 37 Participants | 34 Participants | 71 Participants |
| Sex: Female, Male Male | 57 Participants | 63 Participants | 120 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 100 | 0 / 106 |
| serious Total, serious adverse events | 0 / 100 | 0 / 106 |
Outcome results
Primary
Total Opioid Consumption Measured in Intravenous Morphine Equivalents During the Postoperative Hospital Stay
Total opioid consumption measured in intravenous morphine equivalents during the postoperative hospital stay
Time frame: All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupivacaine | Total Opioid Consumption Measured in Intravenous Morphine Equivalents During the Postoperative Hospital Stay | 17.3 mg (morphine equivalents) |
| Liposomal Bupivacaine | Total Opioid Consumption Measured in Intravenous Morphine Equivalents During the Postoperative Hospital Stay | 15 mg (morphine equivalents) |
Comparison: Statistical analysis was performed using SAS, version 9.2 (Statistical Analysis Software, Cary, NC). All power calculations were at the 80% level with an alpha of 0.05. Based upon opioid consumption data previously reported for robotic-assisted laparoscopic prostatectomy, a sample size of 74 would be necessary to detect a 10 mg difference in morphine equivalents totaled over the entire hospital stay. (Webster TM, Herrell SD, Chang SS, et al. The Journal of Urology 2005;174(3):912-914.p-value: 0.39Wilcoxon (Mann-Whitney)
Secondary
Length of Hospital Stay.
Length of hospital stay.
Time frame: All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.
Secondary
Time to First Opioid Use.
Time to first opioid use.
Time frame: All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.
Secondary
Visual Analog Pain Scores.
Visual analog pain scores.
Time frame: All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.