Improving Pain Management and Decreasing LOS After Total Hip Arthroplasty (THA) and Total Knee Arthroplasty (TKA)

Study Overview
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Brief Summary
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This two arm, patient blinded, randomized, post market clinical trial in a single orthopedic hospital will determine whether there is improved pain management and decreased length of stay when comparing standard of care pain management with and without sufentanil.

Detailed Description
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This two arm, patient blinded, randomized, post market clinical trial in a single orthopedic hospital will determine whether there is improved pain management and decreased length of stay (LOS) when comparing standard of care pain management with and without sufentanil. The objective is to compare LOS between patients who have had primary THA or TKA and have received standard of care peri-operative pain management and one dose of sufentanil 30 mcg sublingual pre-operatively in the operating room and one dose post-operatively in the post anesthesia care unit (PACU) versus those who have received only standard of care peri-operative pain management in a orthopedic specialty hospital.

Official Title
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Improving Pain Management and Decreasing Length of Stay After THA and TKA: A Randomized, Patient-Blinded Comparison of Standard of Care Pain Management With and Without Sufentanil

Conditions
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Pain

Intervention / Treatment
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* Drug: sufentanil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 50 to 80 years, inclusive Planned primary THA or TKA Expressed willingness to be discharged the same day of surgery if condition allows American Society of Anesthesiologists (ASA) physical classes I - III ASA I: A normal healthy patient. Example: Fit, nonobese (BMI under 30), a nonsmoking patient with good exercise tolerance. ASA II: A patient with a mild systemic disease. Example: Patient with no functional limitations and a well-controlled disease (e.g., treated hypertension, obesity with BMI under 35, frequent social drinker or is a cigarette smoker). ASA III: A patient with a severe systemic disease that is not life-threatening. Example: Patient with some functional limitation as a result of disease (e.g., poorly treated hypertension or diabetes, morbid obesity, chronic renal failure, a bronchospastic disease with intermittent exacerbation, stable angina, implanted pacemaker). Patients who are English competent. Exclusion Criteria: Opioid tolerant (> 50 mg oral morphine milligram equivalents (MMEs) daily) Current IV drug abuse History of alcoholism History of severe renal impairment History of severe hepatic impairment Dependent on supplemental oxygen at home Pregnant Incarcerated Patient unable to provide informed consent Patients undergoing bilateral TKA, THA Patient undergoing unicompartmental knee arthroplasty (UKA) Patients undergoing other concurrent surgery Patients with a history of allergy to any drugs in the study.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 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: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two arm, patient blinded, randomized, post market
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>One dose of sufentanil 30 mcg sublingual will be given pre-operatively when entering the operating room and one dose post-operatively in the PACU in addition to standard of care pain management. | Drug: sufentanil<br>* One dose of sufentanil 30 mcg sublingual pre-operatively upon entry to operating room and one dose of sufentanil 30 mcg sublingual in the PACU.<br>* Other names: sufentanil (DSUVIA);|
| No Intervention: Control<br>A multimodal approach to analgesia will be used in all subjects in the perioperative setting and will be used in both the control and treatment groups. Intraoperative dosing of opioids will be based on the anesthesiologist's clinical judgement related to the pain and hemodynamic response to surgical stimuli and on an as needed basis in the PACU. Administration of opioids in the PACU will be in response to moderate-to-severe pain. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | length of hospital stay | From date and time of hospital admission until date and time of hospital discharge, assessed up to 3 days after hospital admission | 
| Discharge location | Discharged from the PACU instead of the Medical-Surgical Unit | At date of discharge from hospital, assessed up to 3 days after hospital admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphine milligram equivalent (MME) doses | the amount of MME doses received | From date and time of hospital admission until date and time of hospital discharge, assessed up to 3 days after hospital admission | 
| side effect(s) | opioid related side effects | From date and time of hospital admission until date and time of hospital discharge, assessed up to 3 days after hospital admission | 
| physical therapy | ability to complete physical therapy in PACU | From admission date and time in PACU until discharge date and time from PACU, assessed for 12 hours after surgery | 
| patient satisfaction | patient reported satisfaction of pain management on a 4-point Likert scale with a higher score being more satisfied | At date and time of discharge from the hospital, within 3 days following hospital admission | 
| hospital costs | total hospital costs | From date of hospital admission until date of hospital discharge, assessed for 3 days following hospital admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, length of stay, peri-operative, THA, TKA