Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Injection Site Irritation, Pain

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Esmolol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: subjects randomized to receive either lidocaine, esmolol, or placebo immediately prior to the administration of propofol for their surgical procedure to treat injection site pain caused by propofol
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | Measure Description | 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 |