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

Sponsor

Prince of Songkla University (Other)

Overall Status

Completed

CT.gov ID

NCT01345981

Collaborator

(none)

210

Enrollment

Location

Arms

Duration (Months)

16.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Adult Disease	Drug: Lidocaine	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: lidocaine 20 mg intravenous lidocaine	Drug: Lidocaine dosage 20 mg and 40 mg
Experimental: lidocaine 40 mg intravenous lidocaine 40 mg	Drug: Lidocaine dosage 20 mg and 40 mg
Placebo Comparator: normal saline 2 ml	Drug: Lidocaine dosage 20 mg and 40 mg

Arm

Intervention/Treatment

Experimental: lidocaine 20 mg

intravenous lidocaine

Drug: Lidocaine

dosage 20 mg and 40 mg

Experimental: lidocaine 40 mg

intravenous lidocaine 40 mg

Drug: Lidocaine

dosage 20 mg and 40 mg

Placebo Comparator: normal saline

2 ml

Drug: Lidocaine

dosage 20 mg and 40 mg

Outcome Measures

Primary Outcome Measures

pain on injection [30 minutes]
4 points score for pain:o=no pain,1=mild pain,2=moderate pain,3=severe pain after propofol injection

Secondary Outcome Measures

hemodynamic change [30 minutes]
blood pressure and heart rate after propofol injection

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Songklanagarind Hospital	Hatyai	Songkhla	Thailand	90110

Sponsors and Collaborators

Prince of Songkla University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01345981

Other Study ID Numbers:

propofol-pain

First Posted:

May 2, 2011

Last Update Posted:

May 2, 2011

Last Verified:

Apr 1, 2011

Additional relevant MeSH terms:

Pain

Lidocaine

Study Results

No Results Posted as of May 2, 2011