A Comparison of Pain Severity on Injection of MCT/LCT Propofol Between Lidocaine 20 mg, 40 mg, and Without Lidocaine.

NCT ID: NCT01345981

Last Updated: 2011-05-02

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

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-11-30

Brief Summary

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To compare the severity of pain on injection of MCT/LCT propofol with lidocaine 20 mg, 40 mg, and without lidocaine.

Detailed Description

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Background: Intravenous injection of propofol produces pain. Many factors are involved and various techniques have been tried to minimize the propofol-induce pain with variable results.

Objective: To compare the severity of pain on injection of MCT/LCT propofol with lidocaine 20 mg, 40 mg, and without lidocaine.

Design: Randomize controlled trial. Method: Two hundred and ten ASA class I - III patients undergoing elective surgery were blinded and equally allocated into 3 groups. Patients in group N, L1, and L2 received MCT/LCT propofol 10 ml mixed with 0.9% NaCl 2 ml, 1% lidocaine 2 ml, and 2% lidocaine 2 ml respectively. Pain at time of propofol injection was assessed by blinded anesthesiologist on a four point scale ; 0 = no pain, 1 = mild pain, 2 = moderate pain, and 3 = severe pain. Results: Patient's demographic data of each group were similar. There were significant differences in the incidence of propofol injection without pain among groups (p\<0.001). The numbers of patients who had moderate and severe pain in groups L1 and L2 were significantly less than those in group N (p\<0.001). The mean blood pressure and heart rate were not significant differences in among groups. Conclusion : The amount of 20 mg, and 40 mg lidocaine to MCT/LCT propofol in our study is equally effective in decreasing pain and more effective than MCT/LCT propofol alone group significantly. They were no significant differences in hemodynamics change in among groups.

Conditions

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Adult Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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lidocaine 20 mg

intravenous lidocaine

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

dosage 20 mg and 40 mg

lidocaine 40 mg

intravenous lidocaine 40 mg

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

dosage 20 mg and 40 mg

normal saline

2 ml

Group Type PLACEBO_COMPARATOR

Lidocaine

Intervention Type DRUG

dosage 20 mg and 40 mg

Interventions

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Lidocaine

dosage 20 mg and 40 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA class I - III patients
* undergoing elective surgery
* age 18-75 years

Exclusion Criteria

* allergy to propofol and lidocaine
* abnormal liver and renal functions
* has psychological problem or drug abuse
* has recieved analgesic drug 2 weeks prior to surgery
* risk of aspiration
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Department of Anesthesiology Faculty of Medicine Prince of Songkla University Thailand

Locations

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Songklanagarind Hospital

Hat Yai, Changwat Songkhla, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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propofol-pain

Identifier Type: -

Identifier Source: org_study_id

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