Pelvic Organ Prolapse
Conditions
Keywords
sacrocolpopexy, rectocele repair
Brief summary
To determine if the injection of liposomal bupivacaine to laparoscopic port sites and rectocele repair incisions at the completion of a robotic sacrocolpopexy with concomitant rectocele repair will result in decreased postoperative pain compared to injection of placebo.
Detailed description
In the last 20 years, laparoscopic surgery has assumed an important role in gynecological surgery. Unfortunately, patient surveys indicate there has been little improvement in the incidence and severity of postsurgical pain in the past two decades. Postoperative pain is a common complaint, occurring in 5-15% of patients and has been shown to significantly contribute to overall patient dissatisfaction. It can lead to increased consumption of opioids, with subsequent nausea, delayed bowel function, and prolonged postoperative recovery. In an attempt to address pain related complications with port-site wounds, various methods of pain control have been attempted. Currently, no standard of care exists and management is based on surgeon and anesthesiologist preferences. This study seeks to determine if the injection of liposomal bupivacaine to laparoscopic port sites and rectocele repair incisions at the completion of a robotic sacrocolpopexy with concomitant rectocele repair will result in decreased postoperative pain compared to injection of placebo.
Interventions
DRUGBupivacaine
At the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure), those subjects in the liposomal bupivacaine arm will have 30mL dilutional volume injected. Ten mL will be injected into the perineum in the posterior vaginal area and 20 mL will be injected the port site wounds in the abdomen (5 sites, 4 ml per incision).
DRUGPlacebo
At the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure), those subjects in the placebo arm will have 30mL total volume injected. Ten mL will be injected into the perineum in the posterior vaginal area and 20 mL will be injected the port site wounds in the abdomen (5 sites, 4 ml per incision).
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults 18 years of age or older * Planning for surgical treatment of POP with robotic sacrocolpopexy and rectocele repair under general anesthesia * Patient undergoing concurrent hysterectomy and/or sub-urethral sling will be included
Exclusion criteria
* Pregnant or nursing * Allergy to bupivacaine * History of drug/alcohol abuse * Severe cardiovascular, hepatic, renal disease, or neurological impairment * Long-acting opioid use within 3 days or any opioid use within 24 hours before surgery * Contraindication to: acetaminophen, oxycodone, non-steroidal anti- inflammatory drugs (NSAID) * Administration of an investigational drug within 30 days before study * Chronic pain syndromes * Daily NSAID/opioid use * Patients not undergoing general anesthesia * Patients undergoing concurrent transvaginal mesh removal, anal sphincteroplasty, or fistula repair
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scales (VAS) for Pain at 18 Hours Postoperatively | 18 hours after surgery | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupivacaine Arm 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) | 33 |
| Placebo Arm 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) | 31 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Abnormal preop lab | 0 | 1 |
| Overall Study | Exclusion criteria - drug use | 1 | 0 |
| Overall Study | Intraoperative surgical findings | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Placebo Arm | Total | Bupivacaine Arm |
|---|---|---|---|
| Age, Continuous | 61 years | 62 years | 64 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 63 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 31 Participants | 64 Participants | 33 Participants |
| Sex/Gender, Customized Female only | 31 Participants | 64 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 31 |
| other Total, other adverse events | 0 / 33 | 0 / 31 |
| serious Total, serious adverse events | 0 / 33 | 0 / 31 |
Outcome results
Primary
Visual Analog Scales (VAS) for Pain at 18 Hours Postoperatively
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.
Time frame: 18 hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupivacaine Arm | Visual Analog Scales (VAS) for Pain at 18 Hours Postoperatively | 15.0 mm |
| Placebo Arm | Visual Analog Scales (VAS) for Pain at 18 Hours Postoperatively | 20.5 mm |
p-value: 0.52Wilcoxon (Mann-Whitney)