Status:
TERMINATED
Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Injection Site Irritation
Pain
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
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...
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 ...
Eligibility Criteria
Inclusion
- 18-60 years of age
- ASA 1-3
- Elective surgical procedure
Exclusion
- 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
Key Trial Info
Start Date :
September 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2023
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04356352
Start Date
September 9 2020
End Date
August 25 2023
Last Update
September 19 2024
Active Locations (1)
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1
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States, 27157