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Pain on Injection of Propofol: a Comparison of Lidocaine and Alkalinized Lidocaine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01773044
First Posted: January 23, 2013
Last Update Posted: January 23, 2013
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 (Responsible Party):
Ülkü Özgül, Inonu University
  Purpose

Aim: The aim of this study was to compare the efficacy of pretreatment 0.5 mg/kg lidocaine and 0.5 mg/kg alkalinized lidocaine for prevention of propofol induced pain.

Methods: In this double-blind, placebo controlled study, 300 adults patients ASA I or II, scheduled to undergo elective surgery, were randomly assigned into three groups of 100 each. Group L, recevied 0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF), Group A, 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF) and control group received isotonic saline pretreatment in the dorsum of the hand, followed by propofol 30 sec later. A blinded researcher assessed the patient's pain level via a four-point scale.


Condition Intervention Phase
Pain on Injection of Propofol,Lidocaine, Alkalinized Lidocaine Drug: alkalinized lidocaine Drug: Lidocaine Drug: Placebo (for alcalinized lidocaine) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Ülkü Özgül, Inonu University:

Primary Outcome Measures:
  • Pain on injection of propofol [ Time Frame: 5 th minutes after propofol injection ]

Enrollment: 300
Study Start Date: September 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: alkalinized lidocaine & lidocaine Drug: alkalinized lidocaine
recevied 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF)
Drug: Lidocaine
0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF),
Active Comparator: alkalinized lidocaine &Placebo Drug: alkalinized lidocaine
recevied 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF)
Drug: Placebo (for alcalinized lidocaine)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • undergoing elective surgery

Exclusion Criteria:

  • allergy to the study drug
  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): NCT01773044


Locations
Turkey
Inonu university medicine faculty
Malatya, Turkey, 44280
Sponsors and Collaborators
Inonu University
  More Information

Publications:
Responsible Party: Ülkü Özgül, department of anesthesiology, Inonu University
ClinicalTrials.gov Identifier: NCT01773044     History of Changes
Other Study ID Numbers: ulkü_1
First Submitted: December 20, 2012
First Posted: January 23, 2013
Last Update Posted: January 23, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Lidocaine
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