Preventing Propofol-associated Injection Pain

January 8, 2021 updated by: Joseph Neal, Benaroya Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98101
        • Benaroya Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

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

Exclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Saline pretreatment, saline admixture
Drug: Saline
3.3 mL normal saline
Active Comparator: Lidocaine pretreatment
Lidocaine pretreatment / saline-propofol admixture
Drug: lidocaine pretreatment
lidocaine 50 mg iv under tourniquet-control
Active Comparator: Lidocaine-Propofol admixture
saline pretreatment / Lidocaine-propofol admixture
Drug: Lidocaine / propofol admixture
lidocaine 50 mg plus propofol 50 mg intravenous (iv)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Immediately after injection of study drug. One time assessment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Immediately after injection of study drug. One time assessment
Satisfaction With Anesthetic Technique
Time Frame: Prior to discharge. One time assessment
Were you satisfied with the anesthetic technique? Yes/No
Prior to discharge. One time assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benaroya Research Institute

Investigators

  • Principal Investigator: Joseph M Neal, MD, Virginia Mason Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

March 16, 2009

First Submitted That Met QC Criteria

March 18, 2009

First Posted (Estimate)

March 19, 2009

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 8, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06091

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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