WithdrawnPhase 4

The Effect of Local Analgesia on Postoperative Gluteal Pain in Patients Undergoing Sacrospinous Ligament Fixation

Stopped: Never received appropriate formulation.

United States0Started 2019-02-02

Plain-language summary

This study will randomize patients to either receive intraoperative administration of local anesthetic and corticosteriod at time of sacrospinous ligament fixation compared to placebo to determine if intraoperative trigger point injection (TPI) improves postoperative gluteal and sciatic pain scores along with use of narcotic pain medications. There is a paucity of data examining interventions to potentially ameliorate the postoperative gluteal pain often associated with sacrospinous ligament colpopexy. Our study aims to determine if a compounded TPI improves postoperative pain scores and minimizes use of narcotic pain medications by 20% compared to controls.

Who can participate

Age range

21 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 21yo or older * English speaking * Stage II or greater pelvic organ prolapse * Sacrospinous Ligament Fixation (SSLF) used as apical suspension * SSLF scheduled to be performed by Dr. Janelle Evans or Dr. Marc Ashby Exclusion Criteria: * Under 21yo * Non English speaking * Patient consented, but SSLF not performed at time of surgery * Patient on chronic opiates preoperatively (greater than three months of use) * Contraindication to Marcaine or Kenalog * Prisoners and those involuntarily confined * Patients with cognitive impairment or those using a legally-authorized representative * Hysterectomy performed at time of suspension

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

objective pain score

Timeframe: 6 weeks postoperative

Trial details

NCT IDNCT03995641

SponsorKettering Health Network

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-12

View on ClinicalTrials.gov More Postoperative Pain trials