Preemptive Local Anesthesia in Vaginal Surgery

Phase 4 Completed 90 enrolled Mayo Clinic

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Preemptive analgesia is an intervention which provides an anesthetic prior to initiating a painful stimulus. This trial is examining the effects of a local anesthetic given at the point of innervation prior to performing a vaginal hysterectomy with suspension sutures.

Timeline

Start: 2006-04
Primary completion: 2008-03
Completion: 2008-03

Outcome

Met primary endpoint

registry Preemptive Local Analgesia (PLA) vs Placebo; p = .003; Mean Difference (Final Values) -1.9 (95% CI -3.2 to -0.7); t-test, 2 sided NCT00318292 ↗

Publications

Results Long JB, Eiland RJ, Hentz JG, Mergens PA, Magtibay PM, Kho RM, Magrina JF, Cornella JL. Randomized trial of preemptive local analgesia in vaginal surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jan;20(1):5-10. doi: 10.1007/s00192-008-0716-6. Epub 2008 Oct 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bupivacaine	Other / unclassified	0.5 %	Other
Subject	Epinephrine	Other / unclassified	—	Other