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

Pain Clinical Trial

Official title:

Improving Pain Management and Decreasing Length of Stay After THA and TKA: A Randomized, Patient-Blinded Comparison of Standard of Care Pain Management With and Without Sufentanil

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05307341
• Other study ID #: Pain20210928.3
• Status: Recruiting
• Phase: Phase 4
• Start date: March 2022
• Est. completion date: June 2023

Study information

• Verified date: March 2022
• Source: More Foundation
• Contact: Marc Jacofsky, PhD
• Phone: 623.537.5642
• Email: marc.jacofsky[@]more-foundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	The CORE Institute Specialty Hospital	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
More Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	side effect(s)	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
Secondary	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
Secondary	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
Secondary	hospital costs	total hospital costs	From date of hospital admission until date of hospital discharge, assessed for 3 days following hospital admission