Trial Outcomes & Findings for Trial Liposomal Bupivacaine Following Retropubic Suburethral Sling for Stress Urinary Incontinence (NCT NCT02296099)

NCT ID: NCT02296099

Last Updated: 2018-08-16

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 114 participants
• Primary outcome timeframe: Day 1
• Results posted on: 2018-08-16

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	57	57
Overall Study COMPLETED	54	55
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial Liposomal Bupivacaine Following Retropubic Suburethral Sling for Stress Urinary Incontinence

Baseline characteristics by cohort

Measure	Liposomal Bupivacaine n=54 Participants 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.	Saline Placebo n=55 Participants 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.	Total n=109 Participants Total of all reporting groups
Age, Continuous	51 years STANDARD_DEVIATION 11 • n=5 Participants	53 years STANDARD_DEVIATION 10 • n=7 Participants	52 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	55 Participants n=7 Participants	109 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	50 Participants n=5 Participants	53 Participants n=7 Participants	103 Participants n=5 Participants
Race/Ethnicity, Customized Race · African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Latina	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	54 Participants n=5 Participants	55 Participants n=7 Participants	109 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Liposomal Bupivacaine n=54 Participants 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.	Saline Placebo n=55 Participants 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.
Pain in the Morning	9.5 scores on a scale Interval 2.0 to 33.25	27.0 scores on a scale Interval 8.0 to 48.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Liposomal Bupivacaine n=54 Participants 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.	Saline Placebo n=55 Participants 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.
Pain Upon Discharge From Post-anesthesia Care Unit (PACU)	1.0 score on a scale Interval 0.0 to 9.0	1.0 score on a scale Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Liposomal Bupivacaine n=54 Participants 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.	Saline Placebo n=55 Participants 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.
Pain Upon Discharge From Same Day Surgery	2.0 score on a scale Interval 0.0 to 11.25	4.0 score on a scale Interval 0.0 to 22.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Liposomal Bupivacaine n=54 Participants 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.	Saline Placebo n=55 Participants 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.
Pain at Four Hours After Discharge Home	3.5 score on a scale Interval 1.0 to 23.25	13.0 score on a scale Interval 3.0 to 42.0

SECONDARY outcome

Timeframe: Day 1 - 3

Cumulative consumption postoperative days 1 - 3

Outcome measures

Measure	Liposomal Bupivacaine n=54 Participants 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.	Saline Placebo n=55 Participants 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.
Total Narcotic Consumption	11.50 morphine equivalents Standard Deviation 12.92	13.39 morphine equivalents Standard Deviation 8.24

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Liposomal Bupivacaine n=54 Participants 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.	Saline Placebo n=55 Participants 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.
Number of Participants Reporting 'Very Satisfied' at the 1 Week Postoperative Visit	39 Participants	45 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Liposomal Bupivacaine n=54 Participants 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.	Saline Placebo n=55 Participants 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.
Number of Participants Reporting 'Very Satisfied' at the 2 Week Postoperative Visit	47 Participants	49 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Liposomal Bupivacaine n=54 Participants 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.	Saline Placebo n=55 Participants 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.
Pain at Bedtime (Current Level of Pain)	18.5 score on a scale Interval 5.0 to 43.25	24.0 score on a scale Interval 9.0 to 46.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Liposomal Bupivacaine n=54 Participants 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.	Saline Placebo n=55 Participants 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.
Pain at Bedtime (Most Intense Pain)	34.5 score on a scale Interval 7.75 to 64.0	34.5 score on a scale Interval 20.0 to 55.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Liposomal Bupivacaine n=54 Participants 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.	Saline Placebo n=55 Participants 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.
Pain at Bedtime (Average Pain)	21.5 score on a scale Interval 7.0 to 39.5	21.5 score on a scale Interval 12.0 to 40.0

Adverse Events

Liposomal Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Research Specialist

TriHealth

Phone: 513-862-2341

Email: ganga_devaiah@trihealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place