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:
Information provided by:
Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01345981
First received: April 25, 2011
Last updated: April 29, 2011
Last verified: April 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345981

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

No publications provided

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
Study First Received: April 25, 2011
Last Updated: April 29, 2011
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Lidocaine
Propofol
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on August 19, 2014