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Completed

NCT Number: NCT01345981

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Songklanagarind Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

dosage 20 mg and 40 mg

Primary outcomes

  1. pain on injection

    Time frame: 30 minutes

    4 points score for pain:o=no pain,1=mild pain,2=moderate pain,3=severe pain after propofol injection

Secondary outcomes

  1. hemodynamic change

    Time frame: 30 minutes

    blood pressure and heart rate after propofol injection

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 2, 2011
Registry last updated
May 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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