Preventing Propofol-associated Injection Pain

NCT ID: NCT00864682

Last Updated: 2021-01-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-04-30

Brief Summary

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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

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Saline pretreatment, saline admixture

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

3.3 mL normal saline

Lidocaine pretreatment

Lidocaine pretreatment / saline-propofol admixture

Group Type ACTIVE_COMPARATOR

lidocaine pretreatment

Intervention Type DRUG

lidocaine 50 mg iv under tourniquet-control

Lidocaine-Propofol admixture

saline pretreatment / Lidocaine-propofol admixture

Group Type ACTIVE_COMPARATOR

Lidocaine / propofol admixture

Intervention Type DRUG

lidocaine 50 mg plus propofol 50 mg intravenous (iv)

Interventions

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Saline

3.3 mL normal saline

Intervention Type DRUG

Lidocaine / propofol admixture

lidocaine 50 mg plus propofol 50 mg intravenous (iv)

Intervention Type DRUG

lidocaine pretreatment

lidocaine 50 mg iv under tourniquet-control

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* weight \>40kg, \<100kg
* ambulatory surgery

Exclusion Criteria

* allergy to propofol or lidocaine
* taking opioids, benzodiazepines, or nonsteroidal antiinflammatory drugs (NSAIDs)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benaroya Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Joseph Neal

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph M Neal, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Mason Medical Center

Locations

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Benaroya Research Institute

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21455088 (View on PubMed)

Other Identifiers

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06091

Identifier Type: -

Identifier Source: org_study_id

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