Back to resultsPreemptive Local Anesthesia in Vaginal Surgery
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
bupivacaine and epinephrine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring preemptive analgesia, paracervical block, vaginal hysterectomy
Eligibility Criteria
Inclusion Criteria: Women undergoing vaginal hysterectomy with McCall's culdoplasty
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PLA
Placebo
Arm Description
Active preemptive local analgesia.
Placebo for preemptive local analgesia.
Outcomes
Primary Outcome Measures
Visual Analogue Scale (VAS) Pain Score
Visual Analogue Scale (VAS) pain score on a scale from 0 (None) to 10 (Worst) points.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00318292
Brief Title
Preemptive Local Anesthesia in Vaginal Surgery
Official Title
Preemptive Local Anesthesia in Vaginal Surgery, A Prospective, Randomised Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
preemptive analgesia, paracervical block, vaginal hysterectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PLA
Arm Type
Experimental
Arm Description
Active preemptive local analgesia.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for preemptive local analgesia.
Intervention Type
Drug
Intervention Name(s)
bupivacaine and epinephrine
Intervention Description
20 ml of 0.5% bupivacaine with 1:200,000 epinephrine paracervical injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
20 ml normal saline injection.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) Pain Score
Description
Visual Analogue Scale (VAS) pain score on a scale from 0 (None) to 10 (Worst) points.
Time Frame
30 minutes post-op
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women undergoing vaginal hysterectomy with McCall's culdoplasty
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime B. Long, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18830553
Citation
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.
Results Reference
result
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Preemptive Local Anesthesia in Vaginal Surgery
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