Preventing Propofol-associated Injection Pain

Benaroya Research Institute

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: lidocaine pretreatment; Drug: Lidocaine / propofol admixture; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00864682

06091

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Saline pretreatment, saline admixture

Treatment:

Drug: Saline

Lidocaine pretreatment

Active Comparator group

Description:

Lidocaine pretreatment / saline-propofol admixture

Treatment:

Drug: lidocaine pretreatment

Lidocaine-Propofol admixture

Active Comparator group

Description:

saline pretreatment / Lidocaine-propofol admixture

Treatment:

Drug: Lidocaine / propofol admixture