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.

Study Overview

• Status: Completed
• Conditions: Adult Disease
• Intervention / Treatment: Drug: Lidocaine

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 Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Songkhla
    • Hatyai, Songkhla, Thailand, 90110
      • Songklanagarind Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain on injection	4 points score for pain:o=no pain,1=mild pain,2=moderate pain,3=severe pain after propofol injection	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hemodynamic change	blood pressure and heart rate after propofol injection	30 minutes

Collaborators and Investigators

• Sponsor: Prince of Songkla University

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: April 25, 2011
• First Submitted That Met QC Criteria: April 29, 2011
• First Posted (Estimate): May 2, 2011

Study Record Updates

• Last Update Posted (Estimate): May 2, 2011
• Last Update Submitted That Met QC Criteria: April 29, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: propofol-pain