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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
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.
The CORE Institute Specialty Hospital
Phoenix, Arizona, United States
RECRUITINGLength of stay
length of hospital stay
Time frame: 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
Time frame: At date of discharge from hospital, assessed up to 3 days after hospital admission
morphine milligram equivalent (MME) doses
the amount of MME doses received
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At date and time of discharge from the hospital, within 3 days following hospital admission
hospital costs
total hospital costs
Time frame: From date of hospital admission until date of hospital discharge, assessed for 3 days following hospital admission
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