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

Sponsor

Inonu University (Other)

Overall Status

Completed

CT.gov ID

NCT01773044

Collaborator

(none)

300

Enrollment

Location

Arms

Duration (Months)

149.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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)

Arm

Intervention/Treatment

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)

Outcome Measures

Primary Outcome Measures

Pain on injection of propofol [5 th minutes after propofol injection]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

undergoing elective surgery

Exclusion Criteria:

allergy to the study drug

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inonu university medicine faculty	Malatya		Turkey	44280

Sponsors and Collaborators

Inonu University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Borazan H, Erdem TB, Kececioglu M, Otelcioglu S. Prevention of pain on injection of propofol: a comparison of lidocaine with different doses of paracetamol. Eur J Anaesthesiol. 2010 Mar;27(3):253-7. doi: 10.1097/EJA.0b013e328330eca2.

Responsible Party:

Ülkü Özgül, department of anesthesiology, Inonu University

ClinicalTrials.gov Identifier:

NCT01773044

Other Study ID Numbers:

ulkü_1

First Posted:

Jan 23, 2013

Last Update Posted:

Jan 23, 2013

Last Verified:

Jan 1, 2013

Additional relevant MeSH terms:

Lidocaine

Study Results

No Results Posted as of Jan 23, 2013