Preventing Propofol-associated Injection Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00864682
• Other study ID #: 06091
• Status: Completed
• Phase: Phase 4
• Start date: January 2008
• Est. completion date: April 2009

Study information

• Verified date: January 2021
• Source: Benaroya Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion criteria:

• weight >40kg, <100kg

• ambulatory surgery

Exclusion criteria:

• allergy to propofol or lidocaine

• taking opioids, benzodiazepines, or nonsteroidal antiinflammatory drugs (NSAIDs)

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Saline
3.3 mL normal saline
• Lidocaine / propofol admixture
lidocaine 50 mg plus propofol 50 mg intravenous (iv)
• lidocaine pretreatment
lidocaine 50 mg iv under tourniquet-control

Locations

Country	Name	City	State
United States	Benaroya Research Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Benaroya Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Verbal Pain Score	11 point verbal pain score (VPS) 0=no pain; 10=worst imaginable pain	Immediately after injection of study drug. One time assessment.
Secondary	Complete Alleviation of Injection Pain	Total subjects within the arm versus those subjects who had no pain with injection (VPS=0)	Immediately after injection of study drug. One time assessment
Secondary	Satisfaction With Anesthetic Technique	Were you satisfied with the anesthetic technique? Yes/No	Prior to discharge. One time assessment