A Phase 4 interventional study of Bupivacaine and Placebo in Pelvic Organ Prolapse, sponsored by TriHealth Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-08.
Sponsored by TriHealth Inc. · Phase 4, Interventional, and Supportive care
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.
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.
521 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.
This study's enrollment of 70 is below the median of 80 across 336 interventional studies indexed under Pelvic Organ Prolapse.
Browse Pelvic Organ Prolapse studies →TriHealth Inc. is the lead sponsor of 102 studies on the registry; 9 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Contraindication
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Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Drug: Bupivacaine
Those subjects in the placebo arm will have 30 mL sterile normal saline injected. Ten mL will be injected into the perineum in the posterior vaginal area and 20 mL will be injected into the port site wounds in the abdomen (5 sites, 4 mL per incision).
Drug: Placebo
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).
Also known as: Exparel
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).
Also known as: Normal Saline
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
| Milestone | Bupivacaine Arm | Placebo Arm |
|---|---|---|
| Started | 35 | 35 |
| Completed | 33 | 31 |
| Not completed | 2 | 4 |
| Withdrew: Exclusion criteria - drug use | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Intraoperative surgical findings | 1 | 1 |
| Withdrew: Abnormal preop lab | 0 | 1 |
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.
| mm | Bupivacaine Arm | Placebo Arm |
|---|---|---|
| Visual Analog Scales (VAS) for Pain at 18 Hours Postoperatively | 15.0 (1 to 35) | 20.5 (2.75 to 41.5) |
Collected over From time of surgery to 12 weeks after surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bupivacaine Arm | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Placebo Arm | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Age, Continuous(years) | Bupivacaine Arm | Placebo Arm | Total |
|---|---|---|---|
| Median | 64 (57 to 68) | 61 (54 to 70) | 62 (55.3 to 68) |
| Sex/Gender, Customized(Participants) | Bupivacaine Arm | Placebo Arm | Total |
|---|---|---|---|
| Female only | 33 | 31 | 64 |
| Ethnicity (NIH/OMB)(Participants) | Bupivacaine Arm | Placebo Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 33 | 30 | 63 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Bupivacaine Arm | Placebo Arm | Total |
|---|---|---|---|
| United States | 33 | 31 | 64 |
The record gives a start of Mar 2015, a primary completion of Aug 2016 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2017, 1 year 4 months after primary completion.
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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bupivacaine