Preventing Propofol-associated Injection Pain

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Saline; Drug: lidocaine pretreatment; Drug: Lidocaine / propofol admixture

• Registration Number: NCT00864682
• Lead Sponsor: Benaroya Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2009-03
• Study First Submitted: 2009-03-16
• Study First Submitted QC: 2009-03-18
• Study First Posted: 2009-03-19
• Results First Submitted: 2009-03-24
• Study Completion: 2009-04
• Results First Submitted QC: 2009-06-15
• Results First Posted: 2009-08-03
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-08
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline	Saline pretreatment, saline admixture
Lidocaine pretreatment	lidocaine pretreatment	Lidocaine pretreatment / saline-propofol admixture
Lidocaine-Propofol admixture	Lidocaine / propofol admixture	saline pretreatment / Lidocaine-propofol admixture

Primary Outcome Measures

Name	Time	Method
Verbal Pain Score	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

Name	Time	Method
Satisfaction With Anesthetic Technique	Prior to discharge. One time assessment	Were you satisfied with the anesthetic technique? Yes/No
Complete Alleviation of Injection Pain	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)

Trial Locations

Locations (1)

Benaroya Research Institute; 🇺🇸 Seattle, Washington, United States