NCT01773044

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

2 months

First QC Date

December 20, 2012

Last Update Submit

January 17, 2013

Conditions

Pain on Injection of Propofol,Lidocaine, Alkalinized Lidocaine

Outcome Measures

Primary Outcomes (1)

  • Pain on injection of propofol

    5 th minutes after propofol injection

Study Arms (2)

alkalinized lidocaine & lidocaine

ACTIVE COMPARATOR
Drug: alkalinized lidocaineDrug: Lidocaine

alkalinized lidocaine &Placebo

ACTIVE COMPARATOR
Drug: alkalinized lidocaineDrug: Placebo (for alcalinized lidocaine)

Interventions

alkalinized lidocaineDRUG

recevied 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF)

alkalinized lidocaine & lidocainealkalinized lidocaine &Placebo
LidocaineDRUG

0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF),

alkalinized lidocaine & lidocaine
Placebo (for alcalinized lidocaine)DRUG
alkalinized lidocaine &Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • undergoing elective surgery

You may not qualify if:

  • allergy to the study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu university medicine faculty

Malatya, 44280, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 19696679BACKGROUND

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
department of anesthesiology

Study Record Dates

First Submitted

December 20, 2012

First Posted

January 23, 2013

Study Start

September 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

TU(1)