A Comparison of Pain Severity on Injection of MCT/LCT Propofol Between Lidocaine 20 mg, 40 mg, and Without Lidocaine.
Primary Purpose
Adult Disease
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Lidocaine
Sponsored by
About this trial
This is an interventional prevention trial for Adult Disease
Eligibility 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
Sites / Locations
- Songklanagarind Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
lidocaine 20 mg
lidocaine 40 mg
normal saline
Arm Description
intravenous lidocaine
intravenous lidocaine 40 mg
2 ml
Outcomes
Primary Outcome Measures
pain on injection
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
blood pressure and heart rate after propofol injection
Full Information
NCT ID
NCT01345981
First Posted
April 25, 2011
Last Updated
April 29, 2011
Sponsor
Prince of Songkla University
1. Study Identification
Unique Protocol Identification Number
NCT01345981
Brief Title
A Comparison of Pain Severity on Injection of MCT/LCT Propofol Between Lidocaine 20 mg, 40 mg, and Without Lidocaine.
Official Title
A Comparison of Pain Severity on Injection of MCT/LCT Propofol Between Lidocaine 20 mg, 40 mg, and Without Lidocaine.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Prince of Songkla University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lidocaine 20 mg
Arm Type
Experimental
Arm Description
intravenous lidocaine
Arm Title
lidocaine 40 mg
Arm Type
Experimental
Arm Description
intravenous lidocaine 40 mg
Arm Title
normal saline
Arm Type
Placebo Comparator
Arm Description
2 ml
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
dosage 20 mg and 40 mg
Primary Outcome Measure Information:
Title
pain on injection
Description
4 points score for pain:o=no pain,1=mild pain,2=moderate pain,3=severe pain after propofol injection
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
hemodynamic change
Description
blood pressure and heart rate after propofol injection
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Songklanagarind Hospital
City
Hatyai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Pain Severity on Injection of MCT/LCT Propofol Between Lidocaine 20 mg, 40 mg, and Without Lidocaine.
We'll reach out to this number within 24 hrs