PainPhase 4NCT05307341
Improving Pain Management and Decreasing LOS After Total Hip Arthroplasty (THA) and Total Knee Arthroplasty (TKA)
A Phase 4 study testing sufentanil in people with Pain, run by More Foundation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Pain
- What is being tested?
- sufentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2022to Jun 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The CORE Institute Specialty Hospital
Phoenix, Arizona, 85015
Rona Curphy, 602-795-6020, rona.curphy@thecoreinstitute.com
John Thompson, MD
About this study
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
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.
Read the 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.
- Conditions
- Pain
- Being tested
- sufentanil
- Keywords
- pain, length of stay, peri-operative, THA, TKA
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sufentanilDrug
Also called sufentanil (DSUVIA)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
length of hospital stay
Measured: 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
Measured: At date of discharge from hospital, assessed up to 3 days after hospital admission
Secondary outcomes (5)
morphine milligram equivalent (MME) doses
the amount of MME doses received
Measured: 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)
opioid related side effects
Measured: From date and time of hospital admission until date and time of hospital discharge, assessed up to 3 days after hospital admission
physical therapy
ability to complete physical therapy in PACU
Measured: From admission date and time in PACU until discharge date and time from PACU, assessed for 12 hours after surgery
patient satisfaction
patient reported satisfaction of pain management on a 4-point Likert scale with a higher score being more satisfied
Measured: At date and time of discharge from the hospital, within 3 days following hospital admission
hospital costs
total hospital costs
Measured: From date of hospital admission until date of hospital discharge, assessed for 3 days following hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study startMar 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two arm, patient blinded, randomized, post market
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- More Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Debra Sietsema, PhD, Study director, More Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307341
- Sponsor's protocol ID
- Pain20210928.3
- Status last verified
- Mar 2022
- First submitted
- 27 Jan 2022
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05307341
- Acronym / sponsor ID
- Pain20210928.3
- Conditions
- Pain
- Keywords
- pain, length of stay, peri-operative, THA, TKA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- More FoundationUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- two arm, patient blinded, randomized, post market
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: sufentanilOne 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. |
| 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Patients who are English competent.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sufentanilAlso: sufentanil (DSUVIA)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. | Drug | Treatment |
Primary outcome
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
length of hospital stay
Discharge location
Time frame: At date of discharge from hospital, assessed up to 3 days after hospital admission
Discharged from the PACU instead of the Medical-Surgical Unit
5 secondary outcomes
morphine milligram equivalent (MME) doses
Time frame: 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)
Time frame: From date and time of hospital admission until date and time of hospital discharge, assessed up to 3 days after hospital admission
physical therapy
Time frame: From admission date and time in PACU until discharge date and time from PACU, assessed for 12 hours after surgery
patient satisfaction
Time frame: At date and time of discharge from the hospital, within 3 days following hospital admission
hospital costs
Time frame: From date of hospital admission until date of hospital discharge, assessed for 3 days following hospital admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra Sietsema, PhD study director
More Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sufentanil in people with Pain, run by More Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Jacofsky, PhD (623.537.5642, marc.jacofsky@more-foundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.