Pelvic Organ Prolapse
Conditions
Brief summary
The purpose of this study is to evaluate the effects of 30 mL intraperitoneal Bupivacaine without epinephrine 0.25% on postoperative pain control in patients undergoing pelvic organ prolapse repair. The investigators hypothesize that use of intraperitoneal Bupivacaine will decrease postoperative pain scores and opiate consumption in the postoperative period, following pelvic organ prolapse repair.
Interventions
DRUGBupivacaine
Intraperitoneal Bupivicaine without epinephrine 30 mg administered following completion of pelvic organ prolapse repair.
OTHERSaline
Placebo
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
4.1 Inclusion Criteria List the criteria: * Age \>= 18 years * Access to cell phone with text messaging capabilities (for same day surgery discharge) * Patients undergoing pelvic organ prolapse repair with peritoneal access 4.2
Exclusion criteria
List the criteria: * Bupivacaine allergy * History of epilepsy or other seizure disorder * EKG demonstrating asymptomatic sinus bradycardia \<40 bpm, symptomatic sinus bradycardia \<60 bpm, first degree AV block, second degree AV block, third degree AV block, prolonged QT, atrial fibrillation, supraventricular tachycardia, or myocardial infarction * Chronic liver disease proved by any ALT or AST elevation greater than 2x upper limit of normal * Serum bilirubin elevation in excess of 5 mg/dL * G6PD deficiency * Weight less than 100 lbs * Chronic opiate use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score at 4 Hours | 4 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score at 8 Hours, 12 Hours and 24 Hours | 8 hours, 12 hours and 24 hours | Pain 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 |
| Total Opiate Consumption | First 24 hours postoperatively | Total opiate consumption postoperatively while inpatient as determined by morphine milligram equivalents (MME) |
| Time to First Narcotic | Up to 24 hours | Time to first narcotic dose during inpatient stay |
| Hospital Length of Stay | Up to 24 hours | Hospital length of stay |
Countries
United States
Participant flow
Recruitment details
All participants underwent pelvic organ prolapse surgery at one academic medical center from August 16, 2023, to March 14, 2024.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 44 |
| Placebo This arm received 30 mL of placebo (saline) via intraperitoneal lavage throughout the pelvis immediately prior to loss of peritoneal access. | 47 |
| Total | 91 |
Baseline characteristics
| Characteristic | Total | Placebo | Intraperitoneal Bupivacaine |
|---|---|---|---|
| Age, Continuous | 57.8 years STANDARD_DEVIATION 12 | 57.9 years STANDARD_DEVIATION 11.7 | 57.7 years STANDARD_DEVIATION 12.3 |
| BMI | 28.9 kg/m^2 STANDARD_DEVIATION 4.47 | 28.7 kg/m^2 STANDARD_DEVIATION 4.25 | 29.0 kg/m^2 STANDARD_DEVIATION 4.68 |
| Concomitant surgeries Anterior colporrhaphy | 19 Participants | 9 Participants | 10 Participants |
| Concomitant surgeries Cystoscopy | 91 Participants | 47 Participants | 44 Participants |
| Concomitant surgeries Enterocele repair | 62 Participants | 33 Participants | 29 Participants |
| Concomitant surgeries Laparoscopic hysterectomy | 13 Participants | 8 Participants | 5 Participants |
| Concomitant surgeries Midurethral sling | 59 Participants | 34 Participants | 25 Participants |
| Concomitant surgeries Other | 11 Participants | 5 Participants | 6 Participants |
| Concomitant surgeries Posterior colporrhaphy | 64 Participants | 34 Participants | 30 Participants |
| Concomitant surgeries Posterior vaginal mesh placement | 20 Participants | 11 Participants | 9 Participants |
| Concomitant surgeries Robotic assisted laparoscopic hysterectomy | 24 Participants | 11 Participants | 13 Participants |
| Concomitant surgeries Salpingectomy | 33 Participants | 18 Participants | 15 Participants |
| Concomitant surgeries Salpingo-oophorectomy | 35 Participants | 18 Participants | 17 Participants |
| Concomitant surgeries Suprapubic catheter | 33 Participants | 18 Participants | 15 Participants |
| Concomitant surgeries Urethral bulking | 3 Participants | 0 Participants | 3 Participants |
| Concomitant surgeries Vaginal hysterectomy | 30 Participants | 15 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 89 Participants | 46 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Menopausal status Postmenopausal | 58 Participants | 30 Participants | 28 Participants |
| Menopausal status Premenopausal | 33 Participants | 17 Participants | 16 Participants |
| Primary surgical intervention Sacrocolpopexy | 61 Participants | 31 Participants | 30 Participants |
| Primary surgical intervention Uterosacral ligament suspension | 30 Participants | 16 Participants | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 88 Participants | 44 Participants | 44 Participants |
| Sex: Female, Male Female | 91 Participants | 47 Participants | 44 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Smoking status Current | 11 Participants | 6 Participants | 5 Participants |
| Smoking status Former | 19 Participants | 8 Participants | 11 Participants |
| Smoking status Never | 61 Participants | 33 Participants | 28 Participants |
| Stage of prolapse Stage 1 | 2 Participants | 1 Participants | 1 Participants |
| Stage of prolapse Stage 2 | 38 Participants | 19 Participants | 19 Participants |
| Stage of prolapse Stage 3 | 44 Participants | 21 Participants | 23 Participants |
| Stage of prolapse Stage 4 | 7 Participants | 6 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 47 |
| other Total, other adverse events | 4 / 44 | 1 / 47 |
| serious Total, serious adverse events | 0 / 44 | 0 / 47 |
Outcome results
Primary
Pain Score at 4 Hours
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
Time frame: 4 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Bupivacaine | Pain Score at 4 Hours | 3.16 score on a scale | Standard Deviation 2.68 |
| Placebo | Pain Score at 4 Hours | 3.77 score on a scale | Standard Deviation 2.52 |
Secondary
Hospital Length of Stay
Hospital length of stay
Time frame: Up to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Bupivacaine | Hospital Length of Stay | 1.0 Days | Standard Deviation 0 |
| Placebo | Hospital Length of Stay | 1.0 Days | Standard Deviation 0.15 |
Secondary
Pain Score at 8 Hours, 12 Hours and 24 Hours
Pain 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
Time frame: 8 hours, 12 hours and 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intraperitoneal Bupivacaine | Pain Score at 8 Hours, 12 Hours and 24 Hours | 8-hour | 3.27 score on a scale | Standard Deviation 3.04 |
| Intraperitoneal Bupivacaine | Pain Score at 8 Hours, 12 Hours and 24 Hours | 12-hour | 2.84 score on a scale | Standard Deviation 2.59 |
| Intraperitoneal Bupivacaine | Pain Score at 8 Hours, 12 Hours and 24 Hours | 24-hour | 3.00 score on a scale | Standard Deviation 2.41 |
| Placebo | Pain Score at 8 Hours, 12 Hours and 24 Hours | 8-hour | 3.30 score on a scale | Standard Deviation 2.37 |
| Placebo | Pain Score at 8 Hours, 12 Hours and 24 Hours | 12-hour | 2.96 score on a scale | Standard Deviation 1.94 |
| Placebo | Pain Score at 8 Hours, 12 Hours and 24 Hours | 24-hour | 2.37 score on a scale | Standard Deviation 1.98 |
Secondary
Time to First Narcotic
Time to first narcotic dose during inpatient stay
Time frame: Up to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Bupivacaine | Time to First Narcotic | 98.0 Minutes | Standard Deviation 38.6 |
| Placebo | Time to First Narcotic | 96.0 Minutes | Standard Deviation 28.3 |
Secondary
Total Opiate Consumption
Total opiate consumption postoperatively while inpatient as determined by morphine milligram equivalents (MME)
Time frame: First 24 hours postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Bupivacaine | Total Opiate Consumption | 25.4 Morphine milligram equivalents | Standard Deviation 22.4 |
| Placebo | Total Opiate Consumption | 22.0 Morphine milligram equivalents | Standard Deviation 16.4 |