Phase 4
N=90
Preemptive Local Anesthesia in Vaginal Surgery
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT00318292 ↗Enrolled (actual)
90
Serious AEs
8.9%
Results posted
Mar 2009
Primary outcome: Primary: Visual Analogue Scale (VAS) Pain Score — 2.5; 4.4 points on a scale — p=.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- bupivacaine and epinephrine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Mayo Clinic
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analogue Scale (VAS) Pain Score |
2.5; 4.4 | .003 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Women undergoing vaginal hysterectomy with McCall's culdoplasty
Data sourced from ClinicalTrials.gov (NCT00318292). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.