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Preventing Propofol-associated Injection Pain

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: March 19, 2009
Last Update Posted: February 7, 2012
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 (Responsible Party):
Joseph Neal, Benaroya Research Institute
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:

Further study details as provided by Joseph Neal, Benaroya Research Institute:

Primary Outcome Measures:
  • Verbal Pain Score [ Time Frame: Immediately after injection of study drug. One time assessment. ]
    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 ]
    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 ]
    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)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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): NCT00864682

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

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
First Submitted: March 16, 2009
First Posted: March 19, 2009
Results First Submitted: March 24, 2009
Results First Posted: August 3, 2009
Last Update Posted: February 7, 2012
Last Verified: February 2012

Keywords provided by Joseph Neal, Benaroya Research Institute:
injection pain

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General