Preemptive Local Anesthesia in Vaginal Surgery

This study has been completed.

Sponsor:

Information provided by:

Mayo Clinic

ClinicalTrials.gov Identifier:

NCT00318292

First received: April 24, 2006

Last updated: October 22, 2010

Last verified: October 2010

History of Changes

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Preemptive Local Anesthesia in Vaginal Surgery, A Prospective, Randomised Trial

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy

Drug Information available for: Epinephrine bitartrate Epinephrine Epinephrine hydrochloride Racepinephrine hydrochloride Racepinephrine Bupivacaine hydrochloride Bupivacaine

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Visual Analogue Scale (VAS) Pain Score [ Time Frame: 30 minutes post-op ] [ Designated as safety issue: No ]
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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women undergoing vaginal hysterectomy with McCall's culdoplasty

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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:

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. Epub 2008 Oct 2.

Responsible Party:	Jeffrey Cornella MD, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00318292 History of Changes
Other Study ID Numbers:	63-06
Study First Received:	April 24, 2006
Results First Received:	February 18, 2009
Last Updated:	October 22, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

preemptive analgesia
paracervical block
vaginal hysterectomy

Additional relevant MeSH terms:

Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Epinephrine
Epinephryl borate
Bupivacaine
Anesthetics
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Central Nervous System Depressants
Central Nervous System Agents
Anesthetics, Local

ClinicalTrials.gov processed this record on June 18, 2013

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