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OpenTrials
Completed

NCT Number: NCT00864682

Preventing Propofol-associated Injection Pain

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Benaroya Research Institute

Seattle, Washington, 98101, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • allergy to propofol or lidocaine
  • taking opioids, benzodiazepines, or nonsteroidal antiinflammatory drugs (NSAIDs)

Treatment and study plan

Saline

Drug

3.3 mL normal saline

Lidocaine / propofol admixture

Drug

lidocaine 50 mg plus propofol 50 mg intravenous (iv)

lidocaine pretreatment

Drug

lidocaine 50 mg iv under tourniquet-control

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. Satisfaction With Anesthetic Technique

    Time frame: Prior to discharge. One time assessment

    Were you satisfied with the anesthetic technique? Yes/No

Sponsors and collaborators

Lead sponsor

Benaroya Research Institute

Other

Registry information

Official study title

Propofol Mixed With Lidocaine Versus Lidocaine Pretreatment With Tourniquet for Alleviation of Pain Associated With Propofol Injection

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 19, 2009
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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