Pelvic Organ Prolapse Clinical Trial
Official title:
Effect of Local Anesthesia on Postoperative Pain Following Sacrospinous Ligament Fixation
During surgery for pelvic organ prolapse, it is common for the surgeon to inject fluid into
the vaginal tissues to help with tissue dissection. It is common that anesthetic medication
is mixed into this fluid to help with pain control after surgery. Usually the pain
medication injected is short-acting. In this study the investigators plan to compare the
usual short-acting injected pain medication with a long-acting injected pain medication to
evaluate whether this improves pain control after surgery.
One type surgical procedure for prolapse will be evaluated. The procedure is sacrospinous
ligament fixation. This is suspension of the vagina to treat pelvic organ prolapse. Study
participants will be randomized to one of two study groups:
1. Lidocaine group (short-acting medication).
2. Liposomal bupivacaine group (long-acting medication)
Information will be collected on study participants, including: demographics, procedure
data, and post-operative information. The primary outcome of this study is determine if use
of long-acting injected local anesthesia at the time of sacrospinous ligament fixation leads
to less post-operative pain compared to short-acting local anesthesia.
Secondary outcomes include:
1. post-operative opioid medication use
2. return to baseline pain status
3. post-operative time to first bowel movement
4. post-operative antiemetic use (nausea medication)
5. results of voiding trial after surgery
6. patient satisfaction with pain control
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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