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Preemptive Local Anesthesia in Vaginal Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00318292
First Posted: April 26, 2006
Last Update Posted: November 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mayo Clinic
  Purpose
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.

Condition Intervention Phase
Pain, Postoperative Drug: bupivacaine and epinephrine Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preemptive Local Anesthesia in Vaginal Surgery, A Prospective, Randomised Trial

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Visual Analogue Scale (VAS) Pain Score [ Time Frame: 30 minutes post-op ]
    Visual Analogue Scale (VAS) pain score on a scale from 0 (None) to 10 (Worst) points.


Enrollment: 90
Study Start Date: April 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PLA
Active preemptive local analgesia.
Drug: bupivacaine and epinephrine
20 ml of 0.5% bupivacaine with 1:200,000 epinephrine paracervical injection.
Placebo Comparator: Placebo
Placebo for preemptive local analgesia.
Drug: Placebo
20 ml normal saline injection.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women undergoing vaginal hysterectomy with McCall's culdoplasty
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00318292


Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Jaime B. Long, M.D. Mayo Clinic
  More Information

Publications:
Responsible Party: Jeffrey Cornella MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00318292     History of Changes
Other Study ID Numbers: 63-06
First Submitted: April 24, 2006
First Posted: April 26, 2006
Results First Submitted: February 18, 2009
Results First Posted: March 18, 2009
Last Update Posted: November 18, 2010
Last Verified: October 2010

Keywords provided by Mayo Clinic:
preemptive analgesia
paracervical block
vaginal hysterectomy

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Bupivacaine
Epinephrine
Racepinephrine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents


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