Trial | NCT02890199  Report issue

Official Title

Effect of Local Anesthesia on Postoperative Pain Following Sacrospinous Ligament Fixation

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    30
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:

Lidocaine group (short-acting medication).
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:

post-operative opioid medication use
return to baseline pain status
post-operative time to first bowel movement
post-operative antiemetic use (nausea medication)
results of voiding trial after surgery
patient satisfaction with pain control
Study Started
Oct 31
2016
Primary Completion
Jun 30
2017
Anticipated
Study Completion
Jul 31
2017
Anticipated
Last Update
Oct 12
2016
Estimate

Drug Bupivacaine liposomal

Drug Lidocaine

Lidocaine group Active Comparator

0.5% lidocaine mixed with 1:200,000 epinephrine 70 milliliters (mL) will be used for local injection at the sacrospinous ligament and for anterior / posterior colporrhaphy

Bupivacaine liposomal group Experimental

1.3% bupivacaine liposomal (20 mL) injected at the sacrospinous ligament 0.5% lidocaine mixed with 1:200,000 epinephrine 50mL for the anterior / posterior colporrhaphy

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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
No Results Posted