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 range21 Years

SexFEMALE

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

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