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The investigator will evaluate the side effects of oliceridine.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oliceridine | Experimental | Patients receive Oliceridine for pain control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oliceridine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically Meaningful Respiratory Compromise Events | Occurrence of clinically meaningful respiratory compromise events i.e. SpO2 ≤ 85 % for ≥3 min, etPCO2 ≤ 15 mmHg; ≥ 3 min, RR ≤ 5 bpm for ≥3 min, Apnea Event >30 s | 48 hours post first study dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel I Sessler, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Bapist Medical Center | Winston-Salem | North Carolina | 27157 | United States | ||
| Cleveland Clinic Fairview Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40446423 | Derived | Sessler DI, Ayad S, Bakal O, Disher NS, Duran JA, Weingarten TN, Dahan A, Demitrack MA, Kim J, Khanna AK; VOLITION Study Team. Oliceridine for postoperative pain and opioid-related complications: The intravenous oliceridine and opioid-related complications (VOLITION) prospective cohort study. J Clin Anesth. 2025 Jul;105:111870. doi: 10.1016/j.jclinane.2025.111870. Epub 2025 May 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oliceridine | Patients receive Oliceridine for pain control. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis population comprised of 203 participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Oliceridine | Patients receive Oliceridine for pain control. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Mean Age of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinically Meaningful Respiratory Compromise Events | Occurrence of clinically meaningful respiratory compromise events i.e. SpO2 ≤ 85 % for ≥3 min, etPCO2 ≤ 15 mmHg; ≥ 3 min, RR ≤ 5 bpm for ≥3 min, Apnea Event >30 s | all enrolled participants | Posted | Number | Events | 48 hours post first study dose. |
|
48 hours post operative
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oliceridine | Patients receive Oliceridine for pain control. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clinically Meaningful Respiratory Compromise Events | Respiratory, thoracic and mediastinal disorders | clinicaltrials.gov | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frank Skobieranda, MD | Trevena, Inc | 610-354-8840 | 248 | fskobieranda@trevenainc.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 5, 2022 | Apr 24, 2026 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| C586842 | ((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine |
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|
| Cleveland |
| Ohio |
| 44111 |
| United States |
| Cleveland Clinic Main Campus | Cleveland | Ohio | 44195 | United States |
| Count of Participants |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Post operative Pain Management | Count of Participants | Participants |
|
|
|
| 0 |
| 203 |
| 0 |
| 203 |
| 45 |
| 203 |
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