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

Phase 4

• Conditions: Pain
• Interventions: Drug: sufentanil

• Registration Number: NCT05307341
• Lead Sponsor: More Foundation

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.

Study Timeline

• Study First Submitted: 2022-01-27
• Status Verified: 2022-03
• Study Start: 2022-03
• Study First Submitted QC: 2022-03-29
• Last Update Submitted: 2022-03-29
• Study First Posted: 2022-04-01
• Last Update Posted: 2022-04-01
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	sufentanil	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
hospital costs	From date of hospital admission until date of hospital discharge, assessed for 3 days following hospital admission	total hospital costs
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

Trial Locations

Locations (1)

The CORE Institute Specialty Hospital; 🇺🇸 Phoenix, Arizona, United States