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

Sponsor
More Foundation (Other)
Overall Status
Recruiting
CT.gov ID
NCT05307341
Collaborator
(none)
100
1
2
15
6.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
two arm, patient blinded, randomized, post markettwo arm, patient blinded, randomized, post market
Masking:
Single (Participant)
Masking Description:
participant will not be informed whether participant is in the standard of care arm or treatment arm.
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

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.
Other Names:
  • sufentanil (DSUVIA)
  • No Intervention: 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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    1. 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

    2. 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

    3. 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

    4. 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

    5. hospital costs [From date of hospital admission until date of hospital discharge, assessed for 3 days following hospital admission]

      total hospital costs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    5. ASA I: A normal healthy patient. Example: Fit, nonobese (BMI under 30), a nonsmoking patient with good exercise tolerance.

    6. 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).

    7. 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).

    8. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The CORE Institute Specialty Hospital Phoenix Arizona United States 85015

    Sponsors and Collaborators

    • More Foundation

    Investigators

    • Study Director: Debra Sietsema, PhD, More Foundation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    More Foundation
    ClinicalTrials.gov Identifier:
    NCT05307341
    Other Study ID Numbers:
    • Pain20210928.3
    First Posted:
    Apr 1, 2022
    Last Update Posted:
    Apr 1, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by More Foundation
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 1, 2022