Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain

NCT04356352 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: IRB00063576
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Conditions

Injection Site Irritation; Pain

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (3)

• Heart Rate

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

• Systolic Blood Pressure

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

• Oxygen Saturation Percentage

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

Study Arms (3)

Lidocaine

ACTIVE COMPARATOR

1 mg/kg lidocaine to a max of 100 mg

Drug: Lidocaine

Esmolol

ACTIVE COMPARATOR

0.5 mg/kg esmolol to a max of 50 mg

Drug: Esmolol

Placebo

PLACEBO COMPARATOR

Saline water

Other: Placebo

Interventions

Lidocaine DRUG

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.

Lidocaine

Esmolol DRUG

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.

Esmolol

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• ASA 1-3
• Elective surgical procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; esmolol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Michael Norton, MD
• Organization: Wake Forest University Health Sciences

mnorton@wakehealth.edu

336-716-8791

Study Officials

• Michael Norton, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: assessor asking for pain scores will be blinded from the randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: April 22, 2020
• Study Start: September 9, 2020
• Primary Completion: August 25, 2023
• Study Completion: August 25, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2023-09

Locations

US (1)