Median Effective Dose of Lidocaine for the Prevention of Pain Caused by the Injection of Propofol Formulated With Medium-/Long-chain Triglycerides

Propofol is widely used in general anesthesia induction, but the occurrence of peripheral intravenous pain is relatively high, causing anxiety, fear and other adverse emotions in patients , aggravating the stress response, and even leading to adverse events of cardiovascular system . The use of mediate-long chain fat emulsion propofol partly reduces the incidence of injection pain but patients can still suffer from different degrees of pain. Advanced intravenous injection of lidocaine can alleviate the pain of propofol injection, but its application method and dose are controversial. It is worthy of further discussion on how to select the appropriate dose of advanced intravenous injection of lidocaine to effectively prevent the injection pain of mediate-long chain fat emulsion propofol, and simultaneously avoid the adverse reactions of intravenous lidocaine, thus improving patient satisfaction and perioperative safety. In this study, in order to provide clinical references, sequential method was used to find the median effective dose (ED50) by means of pre-intravenous injection of lidocaine to suppress pain in mediate-long chain fat emulsion propofol injection.

Study Overview

• Status: Completed
• Conditions: Lidocaine; Injection Pain
• Intervention / Treatment: Drug: Lidocaine

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225012
      • the Affiliated Hospital of Yangzhou University, Yangzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ages ranged from 18 to 65.
• ASA Ⅰ or Ⅱ level.

Exclusion Criteria:

• Allergy or contraindication to lidocaine or propofol; required for Central venipuncture catheterization;
• Abnormal liver or kidney function;
• Heavy drinking and long-term use of sedatives, analgesics or anti-anxiety drugs;
• Hearing and language impairment;
• Peripheral vascular disease;
• Severe cardiovascular disease or neurological disorders;
• Failure of one-time peripheral venipuncture;
• Infection of hand or wrist skin.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Lidocaine pre-intravenous injection; The initial dose of lidocaine for pre-injection was set at 0.5mg /kg according to previous literature and preliminary test results. The dose of lidocaine was according to the patients' pain level. If there is no pain (negative reaction), the dose of lidocaine in the next patient will be reduced until the patient has pain. If there is pain (positive reaction), the dose of lidocaine will be increased in the next patient until the patient is painless.

Drug: Lidocaine; Advanced intravenous injection of lidocaine before the propofol injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The appearance of intravenous injection pain	Yes or No	through study completion, an average of 2 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The levels of intravenous injection pain	The intravenous injection pain in this study was divided into the following 5 levels according to its severity: level 0: After repeated questioning, the patient did not feel any abnormal sensation; level 1: upon inquiry, the patient felt swelling at the intravenous injection site; Level 2: Upon inquiry, the patient felt pain and had no body movement reaction (facial pain expression, arm withdrawal, tears, etc.); Level 3: Upon inquiry, the patient had pain and body movement reaction. Or complain of pain without inquiry; Level 4: the patient has a strong reaction and body movement reaction. Level 2 and above is defined as injection pain.	through study completion, an average of 2 minutes
If any adverse memory or pain during the induction of general anesthesia	Patients recalled by visual analogue scale (VAS) to assess injection pain level : Mark 0 is painless. Mark 10 is violent pain, The numbers between them was pain of varying degrees.	Before patients left the postanesthetic care unit (PACU)

Collaborators and Investigators

• Sponsor: Yangzhou University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 16, 2018
• Primary Completion (ACTUAL): November 16, 2018
• Study Completion (ACTUAL): June 13, 2019

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (ACTUAL): July 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 20190604

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No