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Lidocaine and Ketamine in Abdominal Surgery
NCT04084548Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Oct 2019
- Primary completion
- Dec 2027
- Countries
- 1
- Sponsor
- Cleveland Clinic
- Modality
- Small Molecules
- Conditions
- postoperative pain
01
Overview
Phase 3, randomised, double-blind trial of Lidocaine Hydrochloride Injection, without epinephrine and ketamine in postoperative pain (4 arms), sponsored by Cleveland Clinic. Primary endpoints: Pain scores at 48 hours and Total opioid consumption at 48 hours. Started Oct 2019; status: active, not recruiting.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Lidocaine and placebo
Lidocaine 1.5 mg/kg bolus followed by 2 mg/kg/hour infusion + Placebo infusion
Ketamine and placebo
Ketamine 0.5 mg/kg bolus followed by 0.3 mg/kg/hour infusion + Placebo infusion
Lidocaine and ketamine
Lidocaine 1.5 mg/kg bolus + 2 mg/kg/hour infusion AND Ketamine 0.5 mg/kg bolus + 0.3 mg/kg/hour infusion
Placebo and placebo
Placebo (normal saline) infusions
03
Who it enrols
Adults 18-80 undergoing elective inpatient abdominal surgery lasting >= 2 hours under general anesthesia, excluding those with planned postop ventilation, regional anesthesia, morbid obesity, severe cardiac/hepatic dysfunction, chronic opioid use, or contraindications to study drugs.
04
Endpoints
Primary
Pain scores
Total opioid consumption
Secondary
Overall benefit of analgesia score
Quality of recovery score
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