Preemptive Local Anesthesia in Vaginal Surgery

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: bupivacaine and epinephrine; Drug: Placebo

• Registration Number: NCT00318292
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-24
• Study First Submitted QC: 2006-04-24
• Study First Posted: 2006-04-26
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Results First Submitted: 2009-02-18
• Results First Submitted QC: 2009-03-17
• Results First Posted: 2009-03-18
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-22
• Last Update Posted: 2010-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Women undergoing vaginal hysterectomy with McCall's culdoplasty

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLA	bupivacaine and epinephrine	Active preemptive local analgesia.
Placebo	Placebo	Placebo for preemptive local analgesia.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS) Pain Score	30 minutes post-op	Visual Analogue Scale (VAS) pain score on a scale from 0 (None) to 10 (Worst) points.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States