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More info
You can access this
clinical trial
if you have
Pelvic Organ Prolapse
and you are
between 18 and 95
years old
-
The phase for this study is not defined.
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The purpose

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

Provided treatments

  • Drug: Bupivacaine liposomal
  • Drug: Lidocaine
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Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT02890199. The sponsor of the trial is Hartford Hospital and it is looking for 30 volunteers for the current phase.
Official trial title:
Effect of Local Anesthesia on Postoperative Pain Following Sacrospinous Ligament Fixation