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

Phase 4

Completed

• Conditions: Pain on Injection of Propofol,Lidocaine, Alkalinized Lidocaine
• Interventions: Drug: alkalinized lidocaine; Drug: Lidocaine; Drug: Placebo (for alcalinized lidocaine)

• Registration Number: NCT01773044
• Lead Sponsor: Inonu University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Study First Submitted: 2012-12-20
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-17
• Last Update Submitted: 2013-01-17
• Study First Posted: 2013-01-23
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• undergoing elective surgery

Exclusion Criteria

• allergy to the study drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
alkalinized lidocaine & lidocaine	Lidocaine	-
alkalinized lidocaine & lidocaine	alkalinized lidocaine	-
alkalinized lidocaine &Placebo	alkalinized lidocaine	-
alkalinized lidocaine &Placebo	Placebo (for alcalinized lidocaine)	-

Primary Outcome Measures

Name	Time	Method
Pain on injection of propofol	5 th minutes after propofol injection

Trial Locations

Locations (1)

Inonu university medicine faculty; 🇹🇷 Malatya, Turkey