Trial Outcomes & Findings for Intraperitoneal Bupivacaine for Pelvic Organ Prolapse (NCT NCT06120530)
NCT ID: NCT06120530
Last Updated: 2025-04-20
Results Overview
Patient pain will be measured by means of a numeric rating scale (scale from 0-10 with lower numbers indicating less pain and higher numbers indicating more pain) at 4 hours after surgical pelvic organ prolapse repair
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
91 participants
Primary outcome timeframe
4 hours
Results posted on
2025-04-20
Participant Flow
All participants underwent pelvic organ prolapse surgery at one academic medical center from August 16, 2023, to March 14, 2024.
Participant milestones
| Measure |
Intraperitoneal Bupivacaine
This arm received 30 mL of 0.25% bupivacaine without epinephrine via intraperitoneal lavage throughout the pelvis immediately prior to loss of peritoneal access.
|
Placebo
This arm received 30 mL of placebo (saline) via intraperitoneal lavage throughout the pelvis immediately prior to loss of peritoneal access.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
47
|
|
Overall Study
COMPLETED
|
44
|
47
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intraperitoneal Bupivacaine for Pelvic Organ Prolapse
Baseline characteristics by cohort
| Measure |
Intraperitoneal Bupivacaine
n=44 Participants
This arm received 30 mL of 0.25% bupivacaine without epinephrine via intraperitoneal lavage throughout the pelvis immediately prior to loss of peritoneal access.
|
Placebo
n=47 Participants
This arm received 30 mL of placebo (saline) via intraperitoneal lavage throughout the pelvis immediately prior to loss of peritoneal access.
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.7 years
STANDARD_DEVIATION 12.3 • n=99 Participants
|
57.9 years
STANDARD_DEVIATION 11.7 • n=107 Participants
|
57.8 years
STANDARD_DEVIATION 12.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
BMI
|
29.0 kg/m^2
STANDARD_DEVIATION 4.68 • n=99 Participants
|
28.7 kg/m^2
STANDARD_DEVIATION 4.25 • n=107 Participants
|
28.9 kg/m^2
STANDARD_DEVIATION 4.47 • n=206 Participants
|
|
Smoking status
Current
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Smoking status
Former
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Smoking status
Never
|
28 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Menopausal status
Postmenopausal
|
28 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Menopausal status
Premenopausal
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Primary surgical intervention
Uterosacral ligament suspension
|
14 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Primary surgical intervention
Sacrocolpopexy
|
30 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Concomitant surgeries
Vaginal hysterectomy
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Concomitant surgeries
Laparoscopic hysterectomy
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Concomitant surgeries
Robotic assisted laparoscopic hysterectomy
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Concomitant surgeries
Salpingectomy
|
15 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Concomitant surgeries
Salpingo-oophorectomy
|
17 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Concomitant surgeries
Midurethral sling
|
25 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Concomitant surgeries
Urethral bulking
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Concomitant surgeries
Anterior colporrhaphy
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Concomitant surgeries
Posterior colporrhaphy
|
30 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Concomitant surgeries
Posterior vaginal mesh placement
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Concomitant surgeries
Enterocele repair
|
29 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Concomitant surgeries
Cystoscopy
|
44 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Concomitant surgeries
Suprapubic catheter
|
15 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Concomitant surgeries
Other
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Stage of prolapse
Stage 1
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Stage of prolapse
Stage 2
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Stage of prolapse
Stage 3
|
23 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Stage of prolapse
Stage 4
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 hoursPatient pain will be measured by means of a numeric rating scale (scale from 0-10 with lower numbers indicating less pain and higher numbers indicating more pain) at 4 hours after surgical pelvic organ prolapse repair
Outcome measures
| Measure |
Intraperitoneal Bupivacaine
n=44 Participants
This arm received 30 mL of 0.25% bupivacaine without epinephrine via intraperitoneal lavage throughout the pelvis immediately prior to loss of peritoneal access.
|
Placebo
n=47 Participants
This arm received 30 mL of placebo (saline) via intraperitoneal lavage throughout the pelvis immediately prior to loss of peritoneal access.
|
|---|---|---|
|
Pain Score at 4 Hours
|
3.16 score on a scale
Standard Deviation 2.68
|
3.77 score on a scale
Standard Deviation 2.52
|
SECONDARY outcome
Timeframe: 8 hours, 12 hours and 24 hoursPain scores as determined by numeric rating scale (scale from 0-10 with lower numbers indicating less pain and higher numbers indicating more pain) at approximately 8, 12 and 24 hours
Outcome measures
| Measure |
Intraperitoneal Bupivacaine
n=44 Participants
This arm received 30 mL of 0.25% bupivacaine without epinephrine via intraperitoneal lavage throughout the pelvis immediately prior to loss of peritoneal access.
|
Placebo
n=47 Participants
This arm received 30 mL of placebo (saline) via intraperitoneal lavage throughout the pelvis immediately prior to loss of peritoneal access.
|
|---|---|---|
|
Pain Score at 8 Hours, 12 Hours and 24 Hours
8-hour
|
3.27 score on a scale
Standard Deviation 3.04
|
3.30 score on a scale
Standard Deviation 2.37
|
|
Pain Score at 8 Hours, 12 Hours and 24 Hours
12-hour
|
2.84 score on a scale
Standard Deviation 2.59
|
2.96 score on a scale
Standard Deviation 1.94
|
|
Pain Score at 8 Hours, 12 Hours and 24 Hours
24-hour
|
3.00 score on a scale
Standard Deviation 2.41
|
2.37 score on a scale
Standard Deviation 1.98
|
SECONDARY outcome
Timeframe: First 24 hours postoperativelyTotal opiate consumption postoperatively while inpatient as determined by morphine milligram equivalents (MME)
Outcome measures
| Measure |
Intraperitoneal Bupivacaine
n=44 Participants
This arm received 30 mL of 0.25% bupivacaine without epinephrine via intraperitoneal lavage throughout the pelvis immediately prior to loss of peritoneal access.
|
Placebo
n=47 Participants
This arm received 30 mL of placebo (saline) via intraperitoneal lavage throughout the pelvis immediately prior to loss of peritoneal access.
|
|---|---|---|
|
Total Opiate Consumption
|
25.4 Morphine milligram equivalents
Standard Deviation 22.4
|
22.0 Morphine milligram equivalents
Standard Deviation 16.4
|
SECONDARY outcome
Timeframe: Up to 24 hoursTime to first narcotic dose during inpatient stay
Outcome measures
| Measure |
Intraperitoneal Bupivacaine
n=44 Participants
This arm received 30 mL of 0.25% bupivacaine without epinephrine via intraperitoneal lavage throughout the pelvis immediately prior to loss of peritoneal access.
|
Placebo
n=47 Participants
This arm received 30 mL of placebo (saline) via intraperitoneal lavage throughout the pelvis immediately prior to loss of peritoneal access.
|
|---|---|---|
|
Time to First Narcotic
|
98.0 Minutes
Standard Deviation 38.6
|
96.0 Minutes
Standard Deviation 28.3
|
SECONDARY outcome
Timeframe: Up to 24 hoursHospital length of stay
Outcome measures
| Measure |
Intraperitoneal Bupivacaine
n=44 Participants
This arm received 30 mL of 0.25% bupivacaine without epinephrine via intraperitoneal lavage throughout the pelvis immediately prior to loss of peritoneal access.
|
Placebo
n=47 Participants
This arm received 30 mL of placebo (saline) via intraperitoneal lavage throughout the pelvis immediately prior to loss of peritoneal access.
|
|---|---|---|
|
Hospital Length of Stay
|
1.0 Days
Standard Deviation 0
|
1.0 Days
Standard Deviation 0.15
|
Adverse Events
Intraperitoneal Bupivacaine
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intraperitoneal Bupivacaine
n=44 participants at risk
This arm received 30 mL of 0.25% bupivacaine without epinephrine via intraperitoneal lavage throughout the pelvis immediately prior to loss of peritoneal access.
|
Placebo
n=47 participants at risk
This arm received 30 mL of placebo (saline) via intraperitoneal lavage throughout the pelvis immediately prior to loss of peritoneal access.
|
|---|---|---|
|
Renal and urinary disorders
Other
|
2.3%
1/44 • up to 6 weeks after surgery
|
0.00%
0/47 • up to 6 weeks after surgery
|
|
Gastrointestinal disorders
Other
|
2.3%
1/44 • up to 6 weeks after surgery
|
0.00%
0/47 • up to 6 weeks after surgery
|
|
Skin and subcutaneous tissue disorders
Other
|
2.3%
1/44 • up to 6 weeks after surgery
|
0.00%
0/47 • up to 6 weeks after surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place