Pain on Injection of Propofol: a Comparison of Lidocaine and Alkalinized Lidocaine

NCT ID: NCT01773044

Last Updated: 2013-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-11-30

Brief Summary

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Aim: The aim of this study was to compare the efficacy of pretreatment 0.5 mg/kg lidocaine and 0.5 mg/kg alkalinized lidocaine for prevention of propofol induced pain.

Methods: In this double-blind, placebo controlled study, 300 adults patients ASA I or II, scheduled to undergo elective surgery, were randomly assigned into three groups of 100 each. Group L, recevied 0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF), Group A, 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF) and control group received isotonic saline pretreatment in the dorsum of the hand, followed by propofol 30 sec later. A blinded researcher assessed the patient's pain level via a four-point scale.

Detailed Description

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Conditions

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Pain on Injection of Propofol,Lidocaine, Alkalinized Lidocaine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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alkalinized lidocaine & lidocaine

Group Type ACTIVE_COMPARATOR

alkalinized lidocaine

Intervention Type DRUG

recevied 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF)

Lidocaine

Intervention Type DRUG

0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF),

alkalinized lidocaine &Placebo

Group Type ACTIVE_COMPARATOR

alkalinized lidocaine

Intervention Type DRUG

recevied 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF)

Placebo (for alcalinized lidocaine)

Intervention Type DRUG

Interventions

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alkalinized lidocaine

recevied 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF)

Intervention Type DRUG

Lidocaine

0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF),

Intervention Type DRUG

Placebo (for alcalinized lidocaine)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* undergoing elective surgery

Exclusion Criteria

* allergy to the study drug
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Inonu University

OTHER

Sponsor Role lead

Responsible Party

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Ülkü Özgül

department of anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Inonu university medicine faculty

Malatya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Borazan H, Erdem TB, Kececioglu M, Otelcioglu S. Prevention of pain on injection of propofol: a comparison of lidocaine with different doses of paracetamol. Eur J Anaesthesiol. 2010 Mar;27(3):253-7. doi: 10.1097/EJA.0b013e328330eca2.

Reference Type BACKGROUND
PMID: 19696679 (View on PubMed)

Other Identifiers

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ulkü_1

Identifier Type: -

Identifier Source: org_study_id

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