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

NCT05307341 | Unknown Phase 4 DMC

• 1 other identifier: Pain20210928.3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

pain; length of stay; peri-operative; THA; TKA

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• 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

• 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

• physical therapy

  From admission date and time in PACU until discharge date and time from PACU, assessed for 12 hours after surgery

• patient satisfaction

  At date and time of discharge from the hospital, within 3 days following hospital admission

• hospital costs

  From date of hospital admission until date of hospital discharge, assessed for 3 days following hospital admission

Study Arms (2)

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.

Drug: sufentanil

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.

Interventions

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.

Also known as: sufentanil (DSUVIA)

Treatment

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ASA I: A normal healthy patient. Example: Fit, nonobese (BMI under 30), a nonsmoking patient with good exercise tolerance.
• 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).
• 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).
• Patients who are English competent.

You may not qualify if:

• Opioid tolerant (\> 50 mg oral morphine milligram equivalents (MMEs) daily)
• Current IV drug abuse
• History of alcoholism
• History of severe renal impairment
• History of severe hepatic impairment
• Dependent on supplemental oxygen at home
• Pregnant
• Incarcerated
• Patient unable to provide informed consent
• Patients undergoing bilateral TKA, THA
• Patient undergoing unicompartmental knee arthroplasty (UKA)
• Patients undergoing other concurrent surgery
• Patients with a history of allergy to any drugs in the study.

Sponsors & Collaborators

• More Foundation: lead

Study Sites (1)

The CORE Institute Specialty Hospital

Phoenix, Arizona, 85015, United States

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Sufentanil; Dsuvia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Debra Sietsema, PhD

  More Foundation

  STUDY DIRECTOR

Central Study Contacts

Marc Jacofsky, PhD

CONTACT

623.537.5642; marc.jacofsky@more-foundation.org

John Thompson, MD

CONTACT

866.974.2673; john.thompson@thecoreinstitute.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participant will not be informed whether participant is in the standard of care arm or treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two arm, patient blinded, randomized, post market

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: April 1, 2022
• Study Start: March 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)