Clinical trial NCT02890199: Effect of Local Anesthesia on Postoperative Pain Following Sacrospinous Ligament Fixation
Official title: Effect of Local Anesthesia on Postoperative Pain Following Sacrospinous Ligament Fixation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
Collaborators: name: American Association of Gynecologic Laparoscopists
First posted: 2016-09-07
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Visual analog pain scale
timeFrame: 1 to 120 hours post-operative
Secondary outcomes:
measure: Equivalents of morphine used for pain control post-operative while hospitalized
timeFrame: 1-2 days post-operative
measure: Equivalents of morphine used from the time of hospital discharge to post-operative day 7
timeFrame: 7 days post-operative
measure: Modified surgical pain scale
timeFrame: 3, 7, 14, 28 days post-operative
measure: Time to first bowel movement
timeFrame: 1-28 days post-operative
measure: Post-operative antiemetic use, in hospital
timeFrame: 1-2 days post-operative
measure: Void trial
timeFrame: 1-2 days post-operative
measure: HCHAPS pain questionnaire
timeFrame: 48 hours post-operative
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital, Urogynecology Division
state: Connecticut
Study officials:
affiliation: Hartford Hospital
name: Katie Propst, MD
role: PRINCIPAL_INVESTIGATOR
References: