Pain
Conditions
Keywords
pain, length of stay, peri-operative, THA, TKA
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.
Interventions
DRUGsufentanil
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.
Sponsors
More Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
participant will not be informed whether participant is in the standard of care arm or treatment arm.
Intervention model description
two arm, patient blinded, randomized, post market
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | From date and time of hospital admission until date and time of hospital discharge, assessed up to 3 days after hospital admission | length of hospital stay |
| Discharge location | At date of discharge from hospital, assessed up to 3 days after hospital admission | Discharged from the PACU instead of the Medical-Surgical Unit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| side effect(s) | From date and time of hospital admission until date and time of hospital discharge, assessed up to 3 days after hospital admission | opioid related side effects |
| hospital costs | From date of hospital admission until date of hospital discharge, assessed for 3 days following hospital admission | total hospital costs |
| patient satisfaction | At date and time of discharge from the hospital, within 3 days following hospital admission | patient reported satisfaction of pain management on a 4-point Likert scale with a higher score being more satisfied |
| physical therapy | From admission date and time in PACU until discharge date and time from PACU, assessed for 12 hours after surgery | ability to complete physical therapy in PACU |
| morphine milligram equivalent (MME) doses | From date and time of hospital admission until date and time of hospital discharge, assessed up to 3 days after hospital admission | the amount of MME doses received |
Countries
United States
Contacts
Primary ContactMarc Jacofsky, PhD
Backup ContactJohn Thompson, MD
Outcome results
None listed