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Preventing Propofol-associated Injection Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joseph Neal, Benaroya Research Institute
ClinicalTrials.gov Identifier:
NCT00864682
First received: March 16, 2009
Last updated: February 4, 2012
Last verified: February 2012
History of Changes
  Purpose

Injection of propofol is associated with discomfort in subsets of patients. Local anesthetics have been shown to attenuate this response in some patients. This randomized, double-blind, placebo-controlled trial tests the hypothesis that lidocaine mixed with propofol will be superior to lidocaine administered directly into the vein, under tourniquet control, prior to injection of propofol. Both groups are expected to be superior to placebo.


Condition Intervention Phase
Pain
 Drug: Saline
Drug: Lidocaine / propofol admixture
Drug: lidocaine pretreatment
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Propofol Mixed With Lidocaine Versus Lidocaine Pretreatment With Tourniquet for Alleviation of Pain Associated With Propofol Injection

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Benaroya Research Institute:

Primary Outcome Measures:
  • Verbal Pain Score [ Time Frame: Immediately after injection of study drug. One time assessment. ] [ Designated as safety issue: No ]
    11 point verbal pain score (VPS) 0=no pain; 10=worst imaginable pain


Secondary Outcome Measures:
  • Complete Alleviation of Injection Pain [ Time Frame: Immediately after injection of study drug. One time assessment ] [ Designated as safety issue: No ]
    Total subjects within the arm versus those subjects who had no pain with injection (VPS=0)

  • Satisfaction With Anesthetic Technique [ Time Frame: Prior to discharge. One time assessment ] [ Designated as safety issue: No ]
    Were you satisfied with the anesthetic technique? Yes/No


Enrollment: 156
Study Start Date: January 2008
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Saline pretreatment, saline admixture
 Drug: Saline
3.3 mL normal saline
Active Comparator: Lidocaine pretreatment
Lidocaine pretreatment / saline-propofol admixture
 Drug: lidocaine pretreatment
lidocaine 50 mg iv under tourniquet-control
Active Comparator: Lidocaine-Propofol admixture
saline pretreatment / Lidocaine-propofol admixture
 Drug: Lidocaine / propofol admixture
lidocaine 50 mg plus propofol 50 mg intravenous (iv)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • weight >40kg, <100kg
  • ambulatory surgery

Exclusion criteria:

  • allergy to propofol or lidocaine
  • taking opioids, benzodiazepines, or nonsteroidal antiinflammatory drugs (NSAIDs)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00864682

Locations
United States, Washington
Benaroya Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Benaroya Research Institute
Investigators
Principal Investigator: Joseph M Neal, MD Virginia Mason Medical Center
  More Information

No publications provided by Benaroya Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Joseph Neal, PI, Benaroya Research Institute
ClinicalTrials.gov Identifier: NCT00864682     History of Changes
Other Study ID Numbers: 06091
Study First Received: March 16, 2009
Results First Received: March 24, 2009
Last Updated: February 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Benaroya Research Institute:
propofol
lidocaine
injection pain

Additional relevant MeSH terms:
Lidocaine
Propofol
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
 Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 23, 2013