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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2023-06-30

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.

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two arm, patient blinded, randomized, post market

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

participant will not be informed whether participant is in the standard of care arm or treatment arm.

Study Groups

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Treatment

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.

Group Type ACTIVE_COMPARATOR

sufentanil

Intervention Type 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.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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sufentanil

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.

Intervention Type DRUG

Other Intervention Names

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sufentanil (DSUVIA)

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No