Preemptive Local Anesthesia in Vaginal Surgery
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 24, 2006
CompletedFirst Posted
Study publicly available on registry
April 26, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedResults Posted
Study results publicly available
March 18, 2009
CompletedNovember 18, 2010
October 1, 2010
1.9 years
April 24, 2006
February 18, 2009
October 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analogue Scale (VAS) Pain Score
Visual Analogue Scale (VAS) pain score on a scale from 0 (None) to 10 (Worst) points.
30 minutes post-op
Study Arms (2)
PLA
EXPERIMENTALActive preemptive local analgesia.
Placebo
PLACEBO COMPARATORPlacebo for preemptive local analgesia.
Interventions
20 ml of 0.5% bupivacaine with 1:200,000 epinephrine paracervical injection.
Eligibility Criteria
You may qualify if:
- Women undergoing vaginal hysterectomy with McCall's culdoplasty
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Scottsdale, Arizona, 85259, United States
Related Publications (1)
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.
PMID: 18830553RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michaele Menghini
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Jaime B. Long, M.D.
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 24, 2006
First Posted
April 26, 2006
Study Start
April 1, 2006
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
November 18, 2010
Results First Posted
March 18, 2009
Record last verified: 2010-10