Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain

NCT ID: NCT04356352

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-09
• Study Completion Date: 2023-08-25

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

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

Conditions

Injection Site Irritation; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lidocaine

1 mg/kg lidocaine to a max of 100 mg

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: 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.

Esmolol

0.5 mg/kg esmolol to a max of 50 mg

Group Type: ACTIVE_COMPARATOR

Esmolol

Intervention Type: 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.

Placebo

Saline water

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Norton, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00063576

Identifier Type: -

Identifier Source: org_study_id