Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain

Wake Forest University (WFU)

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Injection Site Irritation; Pain

Treatments: Drug: Esmolol; Other: Placebo; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04356352

IRB00063576

Details and patient eligibility

About

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

Full 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

Enrollment: 33 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

33 participants in 3 patient groups, including a placebo group

Lidocaine

Active Comparator group

Description:

1 mg/kg lidocaine to a max of 100 mg

Treatment:

Drug: Lidocaine

Esmolol

Active Comparator group

Description:

0.5 mg/kg esmolol to a max of 50 mg

Treatment:

Drug: Esmolol

Placebo

Placebo Comparator group

Description:

Saline water

Treatment:

Other: Placebo