The Effect of Local Analgesia on Postoperative Gluteal Pain in Patients Undergoing Sacrospinous Ligament Fixation
Withdrawn before enrolling · Phase 4
Conditions studied: Postoperative Pain, Pelvic Organ Prolapse, Trigger Point Injection, Sacrospinous Ligament Fixation
In brief
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.
Key facts
- Study ID
- NCT03995641
- Run by
- Kettering Health Network
- People needed
- 0
- Starts
- 2019-02-02
- Expected to finish
- 2023-09-12
- Last updated by the study team
- 2025-02-05
Who can join
Age: 21 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Kettering Health Network — Dayton, Ohio, United States
Full record on ClinicalTrials.gov
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