Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT04356352

Collaborator

(none)

150

Enrollment

Location

Arms

45.7

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Injection Site Irritation Pain	Drug: Lidocaine Drug: Esmolol Other: Placebo	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 propofolsubjects 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 (Participant, Care Provider)

Masking Description:

assessor asking for pain scores will be blinded from the randomization

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 9, 2020

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Pain with propofol injection [following administration of a sub-induction dose of propofol, 0.5 mg/kg up to 50 mg, just prior to full induction]
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)

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest Health Sciences	Winston-Salem	North Carolina	United States	27157

Sponsors and Collaborators

Wake Forest University Health Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wake Forest University Health Sciences

ClinicalTrials.gov Identifier:

NCT04356352

Other Study ID Numbers:

IRB00063576

First Posted:

Apr 22, 2020

Last Update Posted:

Jul 27, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Lidocaine

Esmolol

Study Results

No Results Posted as of Jul 27, 2022