Phase II Study of Inhaled AeroLEF for Analgesia After ACL Knee Surgery

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of self-titration to effective analgesia with inhaled AeroLEF in patients with moderate/severe acute pain in the post-surgical setting.

Detailed Description
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After elective ACL knee surgery, consented patients will receive a single dose of AeroLEF for moderate/severe acute pain. Patients stop dosing if they achieve analgesia, complete the maximum available dose, or experience dose-limiting side effects.

Official Title
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A Phase II Study Evaluating Inhaled AeroLEF(Liposome-Encapsulated Fentanyl 500mcg/mL)for Post-Operative Pain in Adults After ACL Knee Surgery.

Conditions
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Pain, Post Operative Pain

Intervention / Treatment
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* Drug: AeroLEF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female between ages 18 years and 60 years. A body mass index of between 18 and 30, inclusive. If a female of child-bearing potential, the patient must have a negative urine pregnancy test at screening and baseline. Scheduled for elective ACL arthroscopic knee repair surgery, and meet the criteria of the American Society of Anesthesiologists [ASA] Physical Status Criteria of Class I or Class II, and suitability for an anesthetic plan limited to general anesthesia (inhalation/IV) with post-operative PCA initiated in a PACU setting and not requiring CPM before the 12 hours post surgery observation is completed. Scheduled for a morning surgery and anticipating remaining in the hospital for an overnight stay. Normal laboratory values for clinical chemistry, haematology and urinalysis. If a patient has abnormal clinically significant laboratory values, inclusion will be permitted at the discretion of the investigator . Physical examination with no clinically relevant findings as determined by the investigator. Able to demonstrate the ability to understand the requirements of the study, willingness to provide written informed consent (prior to any study-related procedures being performed) and able to adhere to the study restrictions, and return for the required assessments. Exclusion Criteria: History of addiction to drugs or alcohol. Exposure to any investigational drug within the 30 days prior to enrolment. Documented hypersensitivity to fentanyl or other opioid analgesics Documented hypersensitivity/allergy to the components of the liposomes used in the AeroLEF formulation History of pulmonary, cardiovascular, neurologic, endocrine, hepatic, GI, or kidney disease or therapy that would jeopardize the patient's well-being by participation in this study (excluded by ASA I and II categories) Currently receiving treatment, or have received treatment in the previous two weeks, with antidepressant or antipsychotic drugs (including monoamine oxidase inhibitors). Clinically significant ongoing medical conditions. Currently receiving treatment for chronic pain. Current therapy with narcotic or CNS-depressant medications. Current chronic therapy with NSAIDs, ASA or acetaminophen within the previous 7 days. Patient, who in the opinion of the investigator, is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments. Blood donation or other blood loss within 45 days prior to enrolment in the study totalling 100 mL or greater.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Drug: AeroLEF<br>* Inhaled AeroLEF (Liposome-Encapsulated Fentanyl 500 mcg/mL) for nebulized administration as required by the patient. Up to a 6 mL volume (2 x 3 mL doses) containing 500 mcg/ml fentanyl.<br>* Other names: Liposome-Encapsulated Fentanyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy variable is the time to effective analgesia following initiation of dosing with AeroLEF |  | Post operative period 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first perceptible analgesic effect |  | Post-operative period 12 hours | 
| Time and total of first rescue analgesic |  | Post-operative period 12 hours | 
| Duration of effective analgesia |  | Post-operative period 12 hours | 
| Pain rating scores |  | Post-operative period 12 hours | 
| Adverse events |  | Post-operative period 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Post Op pain, Fentanyl, Pain Control, Surgery