NCT04979247

Intravenous Oliceridine and Opioid-related Complications

Intravenous Oliceridine and Opioid-related Complications: VOLITION: A Multicenter Pilot Cohort Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigator will evaluate the side effects of oliceridine.

Detailed description

The investigator will evaluate the side effects of oliceridine. Limited information suggests that oliceridine may cause fewer side effects than the standard opioids given post surgery. Oliceridine is effective for treating acute pain, and is approved by the FDA. Patients will wear a device that continuously monitors breathing. Data from this monitor will be blinded to the clinical staff. Primary Aims include: The investigators will evaluate the proportion of patients having an adjudicated meaningful respiratory compromise with a specified precision of 0.15 using a 95% confidence interval at 24 hours post first study dose.

Conditions

• Major Surgery

Interventions

Type	Name	Description
DRUG	Oliceridine	Near the end of surgery, patients will be given ≤1.5 mg of oliceridine as a bolus. Postoperatively, patient-controlled analgesia (PCA) will be started with no background infusion, demand doses of 0.35 mg, with a 6 minute lock-out. Additional boluses (≤1 mg) of oliceridine will be given as deemed necessary (based on NRS score and clinical assessment of the patient) as soon as 15 minutes after the initial 1.5 mg loading dose. In addition to supplemental 1 mg bolus doses, the PCA demand dose can be increased to a maximum of 0.5 mg oliceridine.

Timeline

• Start date: 2021-09-15
• Primary completion: 2023-12-21
• Completion: 2024-01-10
• First posted: 2021-07-28
• Last updated: 2025-10-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study