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NCT03995641
The Effect of Local Analgesia on Postoperative Gluteal Pain in Patients Undergoing Sacrospinous Ligament Fixation
Phase 4 trial testing marcaine and kenalog in Postoperative Pain. Withdrawn.
12 September 2023
Quick facts
| Lead sponsor | Kettering Health Network |
|---|---|
| Phase | Phase 4 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Start date | 2 February 2019 |
| Primary completion | 12 September 2023 |
| Estimated completion | 12 September 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- marcaine and kenalog — full drug profile →
Conditions studied
- Postoperative Pain — all drugs for Postoperative Pain →
- Pelvic Organ Prolapse — all drugs for Pelvic Organ Prolapse →
- Trigger Point Injection — all drugs for Trigger Point Injection →
- Sacrospinous Ligament Fixation — all drugs for Sacrospinous Ligament Fixation →
Sponsor
Kettering Health Network
Who can join
21 and older, female only, with Postoperative Pain or Pelvic Organ Prolapse. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03995641
- Europe PMC full search
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Related trials
Other recruiting trials for Postoperative Pain
Currently open trials in the same condition.
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- NCT07496086 — External Oblique Intercostal Block Versus Transversus Abdominis Plane Combined With Rectus Sheath Block on Postoperative · NA · recruiting
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Other Kettering Health Network trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03995641 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kettering Health Network
- Last refreshed: 5 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03995641.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing