Pelvic Organ Prolapse
Conditions
Brief summary
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
Interventions
DRUGBupivacaine liposomal
DRUGLidocaine
Sponsors
American Association of Gynecologic Laparoscopists
Hartford Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
1. Female gender 2. Age ≥ 18 years, ≤95 years 3. 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 4. Able to give informed consent to participate
Exclusion criteria
1. Male 2. Age \<18 years, \> 95 years 3. Unable or unwilling to give informed consent to participate 4. Pregnancy 5. History of chronic pelvic pain, narcotic abuse, or daily narcotic usage in the last six months 6. Known allergy / intolerance to either lidocaine, bupivacaine liposomal, ketorolac, motrin, or acetaminophen 7. Known renal or hepatic insufficiency 8. Planned hysterectomy at the time of prolapse repair 9. Planned transobturator mid urethral sling at the time of prolapse repair
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog pain scale | 1 to 120 hours post-operative | post-operative pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative antiemetic use, in hospital | 1-2 days post-operative | — |
| Void trial | 1-2 days post-operative | Results of in-hospital void trial |
| HCHAPS pain questionnaire | 48 hours post-operative | Patient satisfaction with pain control |
| Time to first bowel movement | 1-28 days post-operative | Days to first postoperative bowel movement |
| Equivalents of morphine used for pain control post-operative while hospitalized | 1-2 days post-operative | Post-operative opioid use, in hospital |
| Equivalents of morphine used from the time of hospital discharge to post-operative day 7 | 7 days post-operative | Post-operative opioid use, after hospital discharge |
| Modified surgical pain scale | 3, 7, 14, 28 days post-operative | Return to baseline pain status |
Countries
United States
Contacts
Primary ContactKatie Propst, MD
Backup ContactDavid M. O'Sullivan, PhD
Outcome results
None listed