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
  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:


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:
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 April 15, 2014