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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01345981
First Posted: May 2, 2011
Last Update Posted: May 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Prince of Songkla University
  Purpose
To compare the severity of pain on injection of MCT/LCT propofol with lidocaine 20 mg, 40 mg, and without lidocaine.

Condition Intervention
Adult Disease Drug: Lidocaine

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • hemodynamic change [ Time Frame: 30 minutes ]
    blood pressure and heart rate after propofol injection


Enrollment: 210
Study Start Date: October 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01345981


Locations
Thailand
Songklanagarind Hospital
Hatyai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
  More Information

Responsible Party: Assistant Professor Nalinee Kovitwanawong, Department of Anesthesiology Faculty of Medicine Prince of Songkla University Thailand
ClinicalTrials.gov Identifier: NCT01345981     History of Changes
Other Study ID Numbers: propofol-pain
First Submitted: April 25, 2011
First Posted: May 2, 2011
Last Update Posted: May 2, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lidocaine
Propofol
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General