Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain

A Comparison of Lidocaine, Esmolol, and Placebo Without Use of a Tourniquet for Relieving Pain From Intravenous Administration of Propofol

The primary hypothesis is that esmolol and lidocaine, when given without the use of a tourniquet, provide relief of propofol injection pain that is superior to placebo when assessed using the propofol pain scoring tool

Study Overview

• Status: Terminated
• Conditions: Pain; Injection Site Irritation
• Intervention / Treatment: Drug: Lidocaine; Drug: Esmolol; Other: Placebo

Detailed Description

The study will include three arms: lidocaine, esmolol, and placebo. Eligible patients will be 18-60 years old, ASA physical status 1-3, and scheduled for an elective surgical procedure. Patients will be randomized to receive lidocaine, esmolol, or placebo. Both the patients and the administering/observing providers will be blinded to the study drug or placebo being administered

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Lynnette Harris, BSN; Phone Number: 336-716-8791; Email: lcharris@wakehealth.edu
• Study Contact Backup: Name: Michael Norton, MD; Phone Number: 336-716-4498; Email: mnorton@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18-60 years of age
• ASA 1-3
• Elective surgical procedure

Exclusion Criteria:

• BMI ≥ 45
• Pregnancy
• Requirement for RSI or awake intubation
• Suspected or known difficult airway
• Contraindication to IV in either upper extremity
• Chronic pain syndrome including fibromyalgia
• Use of opioids, NSAIDs, or other analgesics within 24 hours (including preoperative PO Celebrex, Lyrica, Tylenol, etc.)
• Any use of opioids in the past three months
• Significant cardiopulmonary or hepatic dysfunction
• Hypersensitivity to study medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lidocaine; 1 mg/kg lidocaine to a max of 100 mg	Drug: Lidocaine; 1 mg/kg lidocaine to a max of 100 mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
Active Comparator: Esmolol; 0.5 mg/kg esmolol to a max of 50 mg	Drug: Esmolol; 0.5 mg/kg esmolol to a max of 50mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
Placebo Comparator: Placebo; Saline water	Other: Placebo; saline water administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain with propofol injection	the proportion of patients with pain using a pain scoring system previously used by studies looking at various remedies to decrease propofol injection pain In this scoring system, patients are observed and their responses and behaviors are rated according a specific rubric (Table 1)	following administration of a sub-induction dose of propofol, 0.5 mg/kg up to 50 mg, just prior to full induction

Secondary Outcome Measures

Outcome Measure	Time Frame
Heart rate	vital signs each minute for the first 10 minutes following induction
Blood pressure	vital signs each minute for the first 10 minutes following induction
Oxygen saturation	vital signs each minute for the first 10 minutes following induction

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Michael Norton, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2020
• Primary Completion (Actual): August 25, 2023
• Study Completion (Actual): August 25, 2023

Study Registration Dates

• First Submitted: April 19, 2020
• First Submitted That Met QC Criteria: April 19, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; 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; Adrenergic beta-1 Receptor Antagonists; Lidocaine; Esmolol
• Other Study ID Numbers: IRB00063576

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes