Effect of Local Anesthesia on Postoperative Pain Following Sacrospinous Ligament Fixation
Status unconfirmed · Not applicable
Conditions studied: Pelvic Organ Prolapse
In brief
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
Key facts
- Study ID
- NCT02890199
- Run by
- Hartford Hospital
- People needed
- 30
- Starts
- 2016-10-01
- Expected to finish
- 2017-07-01
- Last updated by the study team
- 2016-10-12
Who can join
Age: 18 and older, up to 95. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female gender
- Age ≥ 18 years, ≤95 years
- Planned vaginal sacrospinous ligament fixation with anterior and/or posterior colporrhaphy (SSLF APC) to treat pelvic organ prolapse with or without retropubic mid urethral sling
- Able to give informed consent to participate
You may not qualify if…
- Male
- Age <18 years, > 95 years
- Unable or unwilling to give informed consent to participate
- Pregnancy
- History of chronic pelvic pain, narcotic abuse, or daily narcotic usage in the last six months
- Known allergy / intolerance to either lidocaine, bupivacaine liposomal, ketorolac, motrin, or acetaminophen
- Known renal or hepatic insufficiency
- Planned hysterectomy at the time of prolapse repair
- Planned transobturator mid urethral sling at the time of prolapse repair
Where it is running
- Hartford Hospital, Urogynecology Division — Hartford, Connecticut, United States (enrolling)
Full record on ClinicalTrials.gov
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