Recruiting

Pain Management

Sponsor:

More Foundation

Code:

NCT05307341

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

sufentanil

Study Details

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

Study ID

NCT05307341

Start date

Mar, 2022

Status verified date

Mar, 2022

Completion date

Jun, 2023

Anticipated

Primary completion date

Jun, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Length of stay [ Time Frame: From date and time of hospital admission until date and time of hospital discharge, assessed up to 3 days after hospital admission ]
  • Discharge location [ Time Frame: At date of discharge from hospital, assessed up to 3 days after hospital admission ]

Central Contacts and Locations

Locations

The CORE Institute Specialty Hospital

Recruiting

Phoenix, Arizona, United States, 85015

Contacts

Principal Investigator:

John Thompson, MD

More Information

Sponsor

More Foundation

Last update posted

Apr 1, 2022

Last verified

Mar, 2022

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by More Foundation on 2022-04-01.