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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Racepinephrine
Epinephryl borate
Bupivacaine
Anesthetics
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Central Nervous System Depressants
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 31, 2014