Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04356352
• Other study ID #: IRB00063576
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: September 9, 2020
• Est. completion date: August 25, 2023

Study information

• Verified date: September 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: August 25, 2023
• Est. primary completion date: August 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Injection Site Irritation
• Pain

Intervention

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.
• 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.

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

Locations

Country	Name	City	State
United States	Wake Forest Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Heart rate		vital signs each minute for the first 10 minutes following induction
Secondary	Blood pressure		vital signs each minute for the first 10 minutes following induction
Secondary	Oxygen saturation		vital signs each minute for the first 10 minutes following induction