Urinary Incontinence, Stress
Conditions
Keywords
retropubic suburethral sling, stress urinary incontinence, liposomal bupivacaine
Brief summary
The purpose of the study is to determine if the administration of liposomal bupivacaine at the completion of a suburethral sling procedure will result in decreased postoperative pain compared to no injection.
Detailed description
The purpose of the study is to determine if the administration of liposomal bupivacaine at the completion of a suburethral sling procedure will result in decreased postoperative pain compared to no injection. The hypothesis is that administration of liposomal bupivacaine at the completion of retropubic suburethral sling procedure will result in decreased postoperative pain compared to no injection. Although multiple routes for sling placement exist, no difference in pain has been found when comparing obturator verses retropubic suburethral sling. Previous trials have investigated varying formulations of injections along the sling pathway in order to reduce complications such as pain and voiding dysfunction. Local anesthesia along the trocar pathway has shown some improvements in pain. Other techniques, however, have varying results. In 2011, the FDA approved liposomal bupivacaine as a single dose wound infiltration for treatment of postoperative pain following hemorrhoidectomy and bunionectomy. Initial studies demonstrated decreased pain compared to placebo, prolonged release in a bimodal distribution, and greater sensory than motor blockade. Additionally, postoperative benefits such as decreased overall pain, decreased opioid use, and increased time to opioid need were observed. Liposomal bupivacaine may also have the advantage of reducing hospital stays and decreasing overall hospital costs. The side effect profile has similar or improved rates of adverse events compared to traditional bupivacaine, a favorable cardiac profile, and no increased risk of poor wound healing. With such promise, we aim to evaluate the use of liposomal bupivacaine to reduce postoperative pain for the placement of slings to treat stress urinary incontinence. The study will be a blinded randomized controlled trial. Patients randomized to receive liposomal bupivicaine, the standard 20ml vial will be diluted with 1 Oml of saline to a reconstituted volume of 30 ml. Those in the control group will receive 30ml of normal saline injected in the same fashion as the study arm.
Interventions
DRUGliposomal bupivacaine
Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally.
DRUGPlacebo
Normal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally.
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults greater than 18 years of age * Planning for outpatient surgical treatment of stress urinary incontinence with placement of a retropubic suburethral sling under general anesthesia
Exclusion criteria
* Pregnant or nursing * Allergy to bupivacaine * History of drug/alcohol abuse * Severe cardiovascular, hepatic, renal disease, or neurological impairment * Long-acting opioid within 3 days or any opioid use within 24 hours before surgery * Contraindication to: acetaminophen, oxycodone, and/or non-steroidal anti-inflammatory drugs (NSAID) * Administration of an investigational drug within 30 days before study * Chronic pain syndromes * Daily NSAID/opioid use * Patients having concomitant procedures or not undergoing general anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain in the Morning | Day 1 | A visual analog scale (VAS) will be used to have the patient rate her pain in the morning of postoperative day one. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Upon Discharge From Same Day Surgery | 1 day | A visual analog scale (VAS) will be used to have the patient rate her pain upon discharge from same day surgery. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported. |
| Pain Upon Discharge From Post-anesthesia Care Unit (PACU) | 1 day | A visual analog scale (VAS) will be used to have the patient rate her pain upon discharge from the PACU. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported. |
| Pain at Four Hours After Discharge Home | 1 day, 4 hours after discharge from Same Day Surgery | A visual analog scale (VAS) will be used to have the patient rate her pain four hours after being discharged home. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported. |
| Total Narcotic Consumption | Day 1 - 3 | Cumulative consumption postoperative days 1 - 3 |
| Number of Participants Reporting 'Very Satisfied' at the 1 Week Postoperative Visit | 1 week | A likert type scale will be used to have the patient rate their satisfaction with pain control at their one week postoperative visit. Count information for those who were very satisfied were provided. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain at Bedtime (Most Intense Pain) | Day 1 | Before going to bed each night the patient will record the most intense pain using a visual analog scale (VAS). The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported. |
| Pain at Bedtime (Average Pain) | Day 1 | Before going to bed each night the patient will record the average level of pain using a visual analog scale (VAS). The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported. |
| Pain at Bedtime (Current Level of Pain) | Day 1 | Before going to bed each night the patient will record their pain level at that moment using a visual analog scale (VAS). The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported. |
| Number of Participants Reporting 'Very Satisfied' at the 2 Week Postoperative Visit | 2 weeks | A likert type scale will be used to have the patient rate their satisfaction with pain control at their two week postoperative visit. Count information for those who were very satisfied were provided. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liposomal Bupivacaine Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally. | 54 |
| Saline Placebo Normal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally. | 55 |
| Total | 109 |
Baseline characteristics
| Characteristic | Liposomal Bupivacaine | Saline Placebo | Total |
|---|---|---|---|
| Age, Continuous | 51 years STANDARD_DEVIATION 11 | 53 years STANDARD_DEVIATION 10 | 52 years STANDARD_DEVIATION 10 |
| Race/Ethnicity, Customized Race African American | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Latina | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 50 Participants | 53 Participants | 103 Participants |
| Region of Enrollment United States | 54 Participants | 55 Participants | 109 Participants |
| Sex: Female, Male Female | 54 Participants | 55 Participants | 109 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 57 | 0 / 57 |
| serious Total, serious adverse events | 0 / 57 | 0 / 57 |
Outcome results
Primary
Pain in the Morning
A visual analog scale (VAS) will be used to have the patient rate her pain in the morning of postoperative day one. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine | Pain in the Morning | 9.5 scores on a scale |
| Saline Placebo | Pain in the Morning | 27.0 scores on a scale |
Comparison: The null hypothesis is that there is no difference in the pain scores between the two groups.p-value: 0.014Wilcoxon (Mann-Whitney)
Secondary
Number of Participants Reporting 'Very Satisfied' at the 1 Week Postoperative Visit
A likert type scale will be used to have the patient rate their satisfaction with pain control at their one week postoperative visit. Count information for those who were very satisfied were provided.
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liposomal Bupivacaine | Number of Participants Reporting 'Very Satisfied' at the 1 Week Postoperative Visit | 39 Participants |
| Saline Placebo | Number of Participants Reporting 'Very Satisfied' at the 1 Week Postoperative Visit | 45 Participants |
Secondary
Pain at Four Hours After Discharge Home
A visual analog scale (VAS) will be used to have the patient rate her pain four hours after being discharged home. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.
Time frame: 1 day, 4 hours after discharge from Same Day Surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine | Pain at Four Hours After Discharge Home | 3.5 score on a scale |
| Saline Placebo | Pain at Four Hours After Discharge Home | 13.0 score on a scale |
Secondary
Pain Upon Discharge From Post-anesthesia Care Unit (PACU)
A visual analog scale (VAS) will be used to have the patient rate her pain upon discharge from the PACU. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.
Time frame: 1 day
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine | Pain Upon Discharge From Post-anesthesia Care Unit (PACU) | 1.0 score on a scale |
| Saline Placebo | Pain Upon Discharge From Post-anesthesia Care Unit (PACU) | 1.0 score on a scale |
Secondary
Pain Upon Discharge From Same Day Surgery
A visual analog scale (VAS) will be used to have the patient rate her pain upon discharge from same day surgery. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.
Time frame: 1 day
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine | Pain Upon Discharge From Same Day Surgery | 2.0 score on a scale |
| Saline Placebo | Pain Upon Discharge From Same Day Surgery | 4.0 score on a scale |
Secondary
Total Narcotic Consumption
Cumulative consumption postoperative days 1 - 3
Time frame: Day 1 - 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine | Total Narcotic Consumption | 11.50 morphine equivalents | Standard Deviation 12.92 |
| Saline Placebo | Total Narcotic Consumption | 13.39 morphine equivalents | Standard Deviation 8.24 |
Other Pre-specified
Number of Participants Reporting 'Very Satisfied' at the 2 Week Postoperative Visit
A likert type scale will be used to have the patient rate their satisfaction with pain control at their two week postoperative visit. Count information for those who were very satisfied were provided.
Time frame: 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liposomal Bupivacaine | Number of Participants Reporting 'Very Satisfied' at the 2 Week Postoperative Visit | 47 Participants |
| Saline Placebo | Number of Participants Reporting 'Very Satisfied' at the 2 Week Postoperative Visit | 49 Participants |
Other Pre-specified
Pain at Bedtime (Average Pain)
Before going to bed each night the patient will record the average level of pain using a visual analog scale (VAS). The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine | Pain at Bedtime (Average Pain) | 21.5 score on a scale |
| Saline Placebo | Pain at Bedtime (Average Pain) | 21.5 score on a scale |
Other Pre-specified
Pain at Bedtime (Current Level of Pain)
Before going to bed each night the patient will record their pain level at that moment using a visual analog scale (VAS). The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine | Pain at Bedtime (Current Level of Pain) | 18.5 score on a scale |
| Saline Placebo | Pain at Bedtime (Current Level of Pain) | 24.0 score on a scale |
Other Pre-specified
Pain at Bedtime (Most Intense Pain)
Before going to bed each night the patient will record the most intense pain using a visual analog scale (VAS). The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine | Pain at Bedtime (Most Intense Pain) | 34.5 score on a scale |
| Saline Placebo | Pain at Bedtime (Most Intense Pain) | 34.5 score on a scale |