Clinical trial NCT05307341: Improving Pain Management and Decreasing LOS After Total Hip Arthroplasty (THA) and Total Knee Arthroplasty (TKA)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain
Keywords: pain
length of stay
peri-operative
THA
TKA
Lead sponsor: More Foundation
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two arm, patient blinded, randomized, post market
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Adults 50 to 80 years, inclusive
2. Planned primary THA or TKA
3. Expressed willingness to be discharged the same day of surgery if condition allows
4. American Society of Anesthesiologists (ASA) physical classes I - III

   1. ASA I: A normal healthy patient. Example: Fit, nonobese (BMI under 30), a nonsmoking patient with good exercise tolerance.
   2. 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).
   3. 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).
5. Patients who are English competent.

Exclusion Criteria:

1. Opioid tolerant (\> 50 mg oral morphine milligram equivalents (MMEs) daily)
2. Current IV drug abuse
3. History of alcoholism
4. History of severe renal impairment
5. History of severe hepatic impairment
6. Dependent on supplemental oxygen at home
7. Pregnant
8. Incarcerated
9. Patient unable to provide informed consent
10. Patients undergoing bilateral TKA, THA
11. Patient undergoing unicompartmental knee arthroplasty (UKA)
12. Patients undergoing other concurrent surgery
13. Patients with a history of allergy to any drugs in the study.

Primary outcomes:
measure: Length of stay
timeFrame: From date and time of hospital admission until date and time of hospital discharge, assessed up to 3 days after hospital admission
measure: Discharge location
timeFrame: At date of discharge from hospital, assessed up to 3 days after hospital admission
Secondary outcomes:
measure: morphine milligram equivalent (MME) doses
timeFrame: From date and time of hospital admission until date and time of hospital discharge, assessed up to 3 days after hospital admission
measure: side effect(s)
timeFrame: From date and time of hospital admission until date and time of hospital discharge, assessed up to 3 days after hospital admission
measure: physical therapy
timeFrame: From admission date and time in PACU until discharge date and time from PACU, assessed for 12 hours after surgery
measure: patient satisfaction
timeFrame: At date and time of discharge from the hospital, within 3 days following hospital admission
measure: hospital costs
timeFrame: From date of hospital admission until date of hospital discharge, assessed for 3 days following hospital admission
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: The CORE Institute Specialty Hospital
state: Arizona
Study officials:
affiliation: More Foundation
name: Debra Sietsema, PhD
role: STUDY_DIRECTOR
References: