Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain

Phase 3TerminatedNCT04356352

Wake Forest University Health Sciences33 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Injection Site Irritation Pain

Interventions

LidocaineDRUG

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.

EsmololDRUG

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.

PlaceboOTHER

saline water administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Patient Pain Score

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

Time frame: following administration of a sub-induction dose of propofol, 0.5 mg/kg up to 50 mg, just prior to full induction

Secondary Outcomes

Heart Rate

heart rate is measured as numbers on a scale with normal 60-100

Time frame: heart rate is measured each minute for the first 10 minutes following induction

Systolic Blood Pressure

blood pressure measured in mmHg

Time frame: Systolic Blood Pressure is measured each minute for the first 10 minutes following induction

Oxygen Saturation Percentage

oxygen saturation is measured on a percentage, with normal range \>90%

Time frame: Oxygen saturation measured each minute for the first 10 minutes following induction

Data from ClinicalTrials.gov

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