Trial Outcomes & Findings for Improvement of Pain Following Robotic Sacrocolpopexy and Rectocele Repair for Pelvic Organ Prolapse (NCT NCT02449915)
NCT ID: NCT02449915
Last Updated: 2017-12-08
Results Overview
VAS is a validated 100 millimeter scale with no pain as 0 mm and worst pain as 100 mm. Subjects drew a vertical line on the scale corresponding to their pain level.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
18 hours after surgery
Results posted on
2017-12-08
Participant Flow
Participant milestones
| Measure |
Bupivacaine Arm
Receiving 30mL dilutional volume of liposomal bupivacaine at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
|
Placebo Arm
Receiving 30 mL volume of sterile normal saline at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
33
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Bupivacaine Arm
Receiving 30mL dilutional volume of liposomal bupivacaine at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
|
Placebo Arm
Receiving 30 mL volume of sterile normal saline at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
|
|---|---|---|
|
Overall Study
Exclusion criteria - drug use
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Intraoperative surgical findings
|
1
|
1
|
|
Overall Study
Abnormal preop lab
|
0
|
1
|
Baseline Characteristics
Improvement of Pain Following Robotic Sacrocolpopexy and Rectocele Repair for Pelvic Organ Prolapse
Baseline characteristics by cohort
| Measure |
Bupivacaine Arm
n=33 Participants
Receiving 30mL dilutional volume of the liposomal bupivacaine at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
|
Placebo Arm
n=31 Participants
Receiving 30 mL sterile normal saline at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
61 years
n=7 Participants
|
62 years
n=5 Participants
|
|
Sex/Gender, Customized
Female only
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 hours after surgeryVAS is a validated 100 millimeter scale with no pain as 0 mm and worst pain as 100 mm. Subjects drew a vertical line on the scale corresponding to their pain level.
Outcome measures
| Measure |
Bupivacaine Arm
n=33 Participants
Receiving 30mL dilutional volume of liposomal bupivacaine at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
|
Placebo Arm
n=31 Participants
Receiving 30 mL volume of sterile normal saline at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
|
|---|---|---|
|
Visual Analog Scales (VAS) for Pain at 18 Hours Postoperatively
|
15.0 mm
Interval 1.0 to 35.0
|
20.5 mm
Interval 2.75 to 41.5
|
Adverse Events
Bupivacaine Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Arm
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place