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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Active Comparator | 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. |
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| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sufentanil | Drug | 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. |
|
| 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 |
| 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) |
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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
Patients who are English competent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marc Jacofsky, PhD | Contact | 623.537.5642 | marc.jacofsky@more-foundation.org | |
| John Thompson, MD | Contact | 866.974.2673 | john.thompson@thecoreinstitute.com |
| Name | Affiliation | Role |
|---|---|---|
| Debra Sietsema, PhD | More Foundation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The CORE Institute Specialty Hospital | Recruiting | Phoenix | Arizona | 85015 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017409 | Sufentanil |
| C000655104 | Dsuvia |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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two arm, patient blinded, randomized, post market
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participant will not be informed whether participant is in the standard of care arm or treatment arm.
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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 |