Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain

Phase 2

Terminated

• Conditions: Injection Site Irritation; Pain
• Interventions: Drug: Lidocaine; Drug: Esmolol; Other: Placebo

• Registration Number: NCT04356352
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-04-19
• Study First Submitted QC: 2020-04-19
• Study First Posted: 2020-04-22
• Study Start: 2020-09-09
• Primary Completion: 2023-08-25
• Study Completion: 2023-08-25
• Status Verified: 2023-09
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine	Lidocaine	1 mg/kg lidocaine to a max of 100 mg
Esmolol	Esmolol	0.5 mg/kg esmolol to a max of 50 mg
Placebo	Placebo	Saline water

Primary Outcome Measures

Name	Time	Method
Patient Pain Score	following administration of a sub-induction dose of propofol, 0.5 mg/kg up to 50 mg, just prior to full induction	pain scoring system previously used by studies looking at various remedies to decrease Propofol injection pain - 0-10 with 0=no pain up to 10=worst pain imaginable

Secondary Outcome Measures

Name	Time	Method
Heart Rate	heart rate is measured each minute for the first 10 minutes following induction	heart rate is measured as numbers on a scale with normal 60-100
Systolic Blood Pressure	Systolic Blood Pressure is measured each minute for the first 10 minutes following induction	blood pressure measured in mmHg
Oxygen Saturation Percentage	Oxygen saturation measured each minute for the first 10 minutes following induction	oxygen saturation is measured on a percentage, with normal range \>90%

Trial Locations

Locations (1)

Wake Forest Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States