Preventing Propofol-associated Injection Pain
Propofol Mixed With Lidocaine Versus Lidocaine Pretreatment With Tourniquet for Alleviation of Pain Associated With Propofol Injection
1 other identifier
interventional
156
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 pain
Started Jan 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 16, 2009
CompletedFirst Posted
Study publicly available on registry
March 19, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
August 3, 2009
CompletedJanuary 27, 2021
January 1, 2021
1.2 years
March 16, 2009
March 24, 2009
January 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Complete Alleviation of Injection Pain
Immediately after injection of study drug. One time assessment
Satisfaction With Anesthetic Technique
Prior to discharge. One time assessment
Study Arms (3)
Placebo
PLACEBO COMPARATORSaline pretreatment, saline admixture
Lidocaine pretreatment
ACTIVE COMPARATORLidocaine pretreatment / saline-propofol admixture
Lidocaine-Propofol admixture
ACTIVE COMPARATORsaline pretreatment / Lidocaine-propofol admixture
Interventions
lidocaine 50 mg plus propofol 50 mg intravenous (iv)
Eligibility Criteria
You may qualify if:
- weight \>40kg, \<100kg
- ambulatory surgery
You may not qualify if:
- allergy to propofol or lidocaine
- taking opioids, benzodiazepines, or nonsteroidal antiinflammatory drugs (NSAIDs)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Benaroya Research Institute
Seattle, Washington, 98101, United States
Related Publications (1)
Walker BJ, Neal JM, Mulroy MF, Humsi JA, Bittner RC, McDonald SB. Lidocaine pretreatment with tourniquet versus lidocaine-propofol admixture for attenuating propofol injection pain: a randomized controlled trial. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):41-5. doi: 10.1097/AAP.0b013e31820306da.
PMID: 21455088DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joseph M. Neal, MD
- Organization
- Virginia Mason Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph M Neal, MD
Virginia Mason Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
March 16, 2009
First Posted
March 19, 2009
Study Start
January 1, 2008
Primary Completion
March 1, 2009
Study Completion
April 1, 2009
Last Updated
January 27, 2021
Results First Posted
August 3, 2009
Record last verified: 2021-01