TerminatedPhase 2/3

Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain

Stopped: feasibility of enrollment

United States33 participantsStarted 2020-09-09

Plain-language 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

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Patient Pain Score

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

Trial details

NCT IDNCT04356352

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-25

Results submitted2024-08-09

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