Postoperative Pain ManagementPhase 4FUSIONNCT03927911
Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries
A Phase 4 study testing EXPAREL and Bupivacaine in people with Postoperative Pain Management, run by Pacira Pharmaceuticals, Inc at 12 sites in United States.
Trial summary
Primary Objective: The primary objective of this study is to compare postsurgical opioid consumption through 72 hours postsurgery in patients receiving local infiltration analgesia (LIA) with EXPAREL and bupivacaine HCl (EXPAREL group) with that of patients receiving standard of care (SOC) (control group) in adult… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain Management
- What is being tested?
- EXPAREL and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 12 sitesUnited States
- Study dates
- 31 Jul 2019to 4 Aug 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old at the time of screening.
- Primary surgical indication is related to spinal degenerative disease, including any of the following:
- Spinal stenosis
- Spondylolisthesis
- Radiculopathy/instability disc disorders
- Degenerative disc disease
Show all 24Show fewer
- Medically cleared for elective spine surgery.
- Scheduled to undergo:
- Elective (i.e., not emergency)
- Lumbosacral (i.e., L1-S1)
- Posterior approach with posterior instrumentation
- Cohort 1 - Open only:
- Open or mini-open surgical technique with:
- 1-level (i.e., spanning 2 vertebrae) or 2-level (i.e., spanning 3 contiguous vertebrae)
- Primary fusion or revision fusion
- Open or mini-open surgical technique
- Cohort 2 - Tubular or percutaneous cohort only:
- 1-level (i.e., spanning 2 vertebrae) or 2-level (i.e., spanning 3 contiguous vertebrae)
- Primary fusion or revision fusion
- Tubular or percutaneous surgical technique
- Cohort 3 - Lumbar decompression without fusion outpatient cohort only:
- Radiculopathy
- Spinal stenosis
- Able to provide informed consent and adhere to all study assessments and visit schedule
Who cannot join
- Serious spinal pathology determined by Investigator that might meaningfully affect postsurgical outcomes, including any of the following:
- Suspected cauda equina syndrome (e.g., bowel/bladder involvement)
- Infection
- Tumor
- Fracture
- Systemic inflammatory spondyloarthropathy
Show all 49Show fewer
- Contraindication to local anesthesia according to the clinical judgment of the Investigator and based on the EXPAREL label.
- Patients who most likely will require patient-controlled analgesia (PCA) pumps in EXPAREL group.
- Anterior surgical approaches, including any of the following:
- Anterior lumbar interbody fusion (ALIF)
- Oblique lumbar interbody fusion (OLIF)
- Anterior-posterior or 360º fusion
- Lateral surgical approaches, including any of the following:
- Extreme lateral interbody fusion (XLIF)
- Direct lateral interbody fusion (DLIF)
- High-dose presurgical opioid use:
- Mean daily intake greater than 100 mg mEq PO in the past 30 days
- Known allergy, hypersensitivity, or contraindication to any of the following study medications:
- Bupivacaine
- EXPAREL
- Tylenol (acetaminophen)
- Robaxin
- 2 or more NSAIDs
- 2 or more gabapentinoids
- 2 or more rescue opioids (e.g., oxycodone, morphine, hydromorphone)
- 2 or more medications for postoperative nausea, vomiting, or pruritus (e.g., dexamethasone, ondansetron)
- History of severely impaired renal or hepatic function.
- Severe chronic pain that requires analgesic treatment, and in the opinion of the principal Investigator, is likely to meaningfully affect postsurgical outcomes.
- Subjects that have implanted spinal cord stimulator or intrathecal drug pump.
- Any neurologic or psychiatric disorder that might impact postsurgical pain or interfere with study assessments per Investigator discretion.
- Malignancy in the last 2 years.
- History of misuse, abuse, or dependence on opioid analgesics, other prescription drugs, illicit drugs, or alcohol as defined in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition). Dependence or chronic opioid use will be defined as use of more than 30 morphine equivalents per day during the prior 90 days.
- Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
- Body Mass Index < 17 kg/m2 or >44 kg/m2 at screening
- Subjects receiving Worker's Compensation for disability or who are involved in other litigation related to the spine.
- Planned concurrent surgical procedure.
- Previous participation in an EXPAREL study.
- Administration of any investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
- In addition, the subject might be excluded from the study prior to study drug infiltration if one of the following criteria during the surgical procedure is met:
- Unable to place planned surgical instrumentation
- Poor fixation at the time of surgical instrumentation
- In addition, the subject must be considered an early termination if one of the following criteria after the surgical procedure is met:
- An incision size >20 cm
- Autograft taken from a harvest site other than surgical site (i.e., iliac crest autograft)
- Intraoperative complications likely to meaningfully affect postsurgical outcomes, including any of the following:
- Clinically significant and prolonged (i.e., >24 hours) neurologic deficit (e.g., foot drop)
- Dural tear or suspected dural tear requiring bed rest (exception: subject will be allowed if the dural tear is fixed as per SOC of the institution during surgery)
- Extensive bleeding (i.e., >1,000 mL blood loss)
- Symptomatic epidural hematoma
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
First Surgical Hospital
Bellaire, Texas, 77401
Marcus Neuroscience Institute
Boca Raton, Florida, 33486
Carolina NeuroSurgery & Spine Associates, P.A.
Charlotte, North Carolina, 28204
The Ohio State University
Columbus, Ohio, 43203
M3-Emerging Medical Research, LLC
Durham, North Carolina, 27704
NorthShore University HealthSystem
Evanston, Illinois, 60201
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
University of Miami
Miami, Florida, 33136
Yale School of Medicine
New Haven, Connecticut, 06511
The Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, 42003
Summit Spine Institute
Portland, Oregon, 97225
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: A Multicenter, Prospective, Active Controlled, Real World, Phase 4 Study of EXPAREL in Multimodal Regimens Compared With Standard of Care for Postsurgical Pain Management in Subjects Undergoing Lumbar Posterior Spine Surgeries (FUSION)
Primary Objective: The primary objective of this study is to compare postsurgical opioid consumption through 72 hours postsurgery in patients receiving local infiltration analgesia (LIA) with EXPAREL and bupivacaine HCl (EXPAREL group) with that of patients receiving standard of care (SOC) (control group) in adult subjects undergoing posterior lumbar spine surgeries where both groups are receiving a multimodal pain regimen.
Secondary Objectives: The secondary objectives of this study are to:
- Compare safety and effectiveness outcomes following LIA with EXPAREL and bupivacaine hydrochloride (HCl) versus SOC in adult subjects undergoing posterior lumbar spine surgeries through 72 hours, including time to first opioid and opioid-related adverse events (ORAEs).
- Compare health outcomes following LIA with EXPAREL and bupivacaine hydrochloride (HCl) versus SOC in adult subjects undergoing posterior lumbar spine surgeries, including discharge readiness, hospital (or other facility) length of stay (LOS), discharge disposition, hospital readmissions, and health service utilization.
Read the detailed description
This is a Phase 4, multicenter, prospective, active-controlled, real world, study in approximately 225 adult subjects undergoing posterior lumbar spine surgery under general anesthesia.
Subjects will be screened within 30 days prior to surgery; screening on the day of surgery will be allowed but is discouraged. If a subject can only be screened on the day of surgery, the informed consent process must still be started at least 24 hours prior to the conduct of any screening procedures that are not considered SOC at the institution and such procedures may not be performed until written informed consent is provided. All screening procedures that are not SOC must be performed and documented within the 30-day time window (inclusive of the day of surgery for those subjects who can only be screened on the day of surgery) as described here.
During the screening visit, subjects will be assessed for any past or present medical conditions that in the opinion of the investigator would preclude them from study participation. After the ICF is signed, the following information will be recorded and procedures done: medical history, surgical history, medication history, the subject's opioid use history will be recorded to calculate mean daily mg oral morphine equivalent dosing (MED PO) in the last 30 days, demographic and background information, height, weight and body mass index (BMI), a urine pregnancy test for women of childbearing potential, and the subject's current adverse experiences (AEs), if any.
Subjects will be asked questions and/or be asked to fill forms as part of the following assessments: Brief Pain Inventory - short form (BPI-sf), 5-item Opioid Compliance Checklist (OCC), Hospital Anxiety and Depression Scale (HADS), Survey of Pain Attitudes (SOPA), Numeric Rating Scale (NRS) ti assess pain and Opioid Related Symptom Distress Scale (ORSDS).
Based on the planned surgical procedure, subjects will be placed in one of three cohorts:
- Cohort 1 - Open lumbar spinal fusion technique; ("open" cohort)
- Cohort 2 - Minimally invasive tubular and/or percutaneous pedicle screw insertion for lumbar decompression with or without fusion;("tubular/percutaneous without midline incision" cohort)
- Cohort 3 - Lumbar decompression surgery (LDS) without fusion (discectomy or laminectomy outpatient cohort)
The initial sample size in each study cohort (i.e., cohort 1, cohort 2 and cohort 3) is estimated at 75 subjects (50 subjects with EXPAREL and 25 subjects with Control group), for a total of 225 subjects in all three cohorts. Within each assigned cohort, subjects will be allocated in a 2:1 ratio to the EXPAREL (50 subjects) and Control group (25 subjects).
The following sequence will be followed for all cohorts: First, the subjects who meet eligibility criteria will be treated according to the institution's SOC. Their data will be collected prospectively. Next, at each investigational site, the administration of EXPAREL and bupivacaine HCl to the first 1 to 3 subjects in each cohort will be observed to ensure that the correct procedure for infiltration as described in the infiltration guide is being followed. If the infiltration was performed correctly, the subject will be included in the study. If the infiltration was performed incorrectly, the subject will continue in the study but will be removed from statistical analysis and will be replaced to ensure at least 50 evaluable EXPAREL patients are enrolled per cohort. If subjects are discontinued for other reasons, they will be replaced such that a total sample size of 75 fully evaluable subjects is obtained in each study cohort, with 50 in the EXPAREL group and 25 in the Control group.
- Conditions
- Postoperative Pain Management
- Being tested
- EXPAREL and Bupivacaine, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXPAREL and BupivacaineDrug
Drug: EXPAREL and Bupivacaine HCl 0.5%
Standard of CareDrug
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Open or mini-open surgical technique cohort | Active comparator | Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort Receives: Drug: EXPAREL and Bupivacaine; Drug: Standard of Care |
| Tubular or Percutaneous cohort (Minimally Invasive Cohort) | Active comparator | Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort Receives: Drug: EXPAREL and Bupivacaine; Drug: Standard of Care |
| Lumbar decompression without fusion (Outpatient Cohort) | Active comparator | Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort Receives: Drug: EXPAREL and Bupivacaine; Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-surgical Opioid Consumption in mg MED PO (0-72 Hours)
Post-surgical opioid consumption in mg MED PO from 0 hours (end of surgery) to 72 hours postsurgery
Measured: 0-72 hours
Secondary outcomes (2)
Post-surgical Opioid Consumption in mg MED PO at 14 Days After Surgery
Post-surgical opioid consumption in mg MED PO at 14 days after surgery
Measured: 0-14 days after surgery
Time to First Opioid Rescue Through 72 Hours or Discharge.
Time to first opioid rescue through 72 hours or discharge.
Measured: 0-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start31 Jul 2019
- Primary completion4 Aug 2020
- Study completion4 Aug 2020
Why it stopped: Due to protocol feasibility given the rapid evolution of medical practice for spinal procedure. Data from approximately 65 FUSION study subjects will be analyzed with the intent to create either a future study or registry for this patient population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative Pain ManagementStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Nevins, DC, Study director, Pacira Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927911
- Sponsor's protocol ID
- 402-C-413
- Acronym
- FUSION
- Status last verified
- Oct 2021
- First submitted
- 19 Apr 2019
- Last updated
- 9 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Active Controlled, Real World, Phase 4 Study of EXPAREL in Multimodal Regimens Compared With Standard of Care for Postsurgical Pain Management in Subjects Undergoing Lumbar Posterior Spine Surgeries (FUSION)
- ClinicalTrials.gov ID
- NCT03927911
- Acronym / sponsor ID
- FUSION / 402-C-413
- Conditions
- Postoperative Pain Management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to protocol feasibility given the rapid evolution of medical practice for spinal procedure. Data from approximately 65 FUSION study subjects will be analyzed with the intent to create either a future study or registry for this patient population.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 4 Aug 2020 (actual)
- Study completion
- 4 Aug 2020 (actual)
- First posted
- 25 Apr 2019 (actual)
- Results
- Posted 9 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective: The primary objective of this study is to compare postsurgical opioid consumption through 72 hours postsurgery in patients receiving local infiltration analgesia (LIA) with EXPAREL and bupivacaine HCl (EXPAREL group) with that of patients receiving standard of care (SOC) (control group) in adult subjects undergoing posterior lumbar spine surgeries where both groups are receiving a multimodal pain regimen.
Secondary Objectives: The secondary objectives of this study are to:
- Compare safety and effectiveness outcomes following LIA with EXPAREL and bupivacaine hydrochloride (HCl) versus SOC in adult subjects undergoing posterior lumbar spine surgeries through 72 hours, including time to first opioid and opioid-related adverse events (ORAEs).
- Compare health outcomes following LIA with EXPAREL and bupivacaine hydrochloride (HCl) versus SOC in adult subjects undergoing posterior lumbar spine surgeries, including discharge readiness, hospital (or other facility) length of stay (LOS), discharge disposition, hospital readmissions, and health service utilization.
Detailed description
This is a Phase 4, multicenter, prospective, active-controlled, real world, study in approximately 225 adult subjects undergoing posterior lumbar spine surgery under general anesthesia.
Subjects will be screened within 30 days prior to surgery; screening on the day of surgery will be allowed but is discouraged. If a subject can only be screened on the day of surgery, the informed consent process must still be started at least 24 hours prior to the conduct of any screening procedures that are not considered SOC at the institution and such procedures may not be performed until written informed consent is provided. All screening procedures that are not SOC must be performed and documented within the 30-day time window (inclusive of the day of surgery for those subjects who can only be screened on the day of surgery) as described here.
During the screening visit, subjects will be assessed for any past or present medical conditions that in the opinion of the investigator would preclude them from study participation. After the ICF is signed, the following information will be recorded and procedures done: medical history, surgical history, medication history, the subject's opioid use history will be recorded to calculate mean daily mg oral morphine equivalent dosing (MED PO) in the last 30 days, demographic and background information, height, weight and body mass index (BMI), a urine pregnancy test for women of childbearing potential, and the subject's current adverse experiences (AEs), if any.
Subjects will be asked questions and/or be asked to fill forms as part of the following assessments: Brief Pain Inventory - short form (BPI-sf), 5-item Opioid Compliance Checklist (OCC), Hospital Anxiety and Depression Scale (HADS), Survey of Pain Attitudes (SOPA), Numeric Rating Scale (NRS) ti assess pain and Opioid Related Symptom Distress Scale (ORSDS).
Based on the planned surgical procedure, subjects will be placed in one of three cohorts:
- Cohort 1 - Open lumbar spinal fusion technique; ("open" cohort)
- Cohort 2 - Minimally invasive tubular and/or percutaneous pedicle screw insertion for lumbar decompression with or without fusion;("tubular/percutaneous without midline incision" cohort)
- Cohort 3 - Lumbar decompression surgery (LDS) without fusion (discectomy or laminectomy outpatient cohort)
The initial sample size in each study cohort (i.e., cohort 1, cohort 2 and cohort 3) is estimated at 75 subjects (50 subjects with EXPAREL and 25 subjects with Control group), for a total of 225 subjects in all three cohorts. Within each assigned cohort, subjects will be allocated in a 2:1 ratio to the EXPAREL (50 subjects) and Control group (25 subjects).
The following sequence will be followed for all cohorts: First, the subjects who meet eligibility criteria will be treated according to the institution's SOC. Their data will be collected prospectively. Next, at each investigational site, the administration of EXPAREL and bupivacaine HCl to the first 1 to 3 subjects in each cohort will be observed to ensure that the correct procedure for infiltration as described in the infiltration guide is being followed. If the infiltration was performed correctly, the subject will be included in the study. If the infiltration was performed incorrectly, the subject will continue in the study but will be removed from statistical analysis and will be replaced to ensure at least 50 evaluable EXPAREL patients are enrolled per cohort. If subjects are discontinued for other reasons, they will be replaced such that a total sample size of 75 fully evaluable subjects is obtained in each study cohort, with 50 in the EXPAREL group and 25 in the Control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open or mini-open surgical technique cohort | Active comparator | Drug: EXPAREL and Bupivacaine, Drug: Standard of CareLocal infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort |
| Tubular or Percutaneous cohort (Minimally Invasive Cohort) | Active comparator | Drug: EXPAREL and Bupivacaine, Drug: Standard of CareLocal infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort |
| Lumbar decompression without fusion (Outpatient Cohort) | Active comparator | Drug: EXPAREL and Bupivacaine, Drug: Standard of CareLocal infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 18-75 years old at the time of screening.
- Primary surgical indication is related to spinal degenerative disease, including any of the following:
- Medically cleared for elective spine surgery.
- Scheduled to undergo:
- Cohort 1 - Open only:
Key exclusion criteria (49 listed)
- Serious spinal pathology determined by Investigator that might meaningfully affect postsurgical outcomes, including any of the following:
- Contraindication to local anesthesia according to the clinical judgment of the Investigator and based on the EXPAREL label.
- Patients who most likely will require patient-controlled analgesia (PCA) pumps in EXPAREL group.
- Anterior surgical approaches, including any of the following:
- Lateral surgical approaches, including any of the following:
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 |
|---|---|---|
| EXPAREL and BupivacaineDrug: EXPAREL and Bupivacaine HCl 0.5% | Drug | Lumbar decompression without fusion (Outpatient Cohort), Open or mini-open surgical technique cohort, Tubular or Percutaneous cohort (Minimally Invasive Cohort) |
| Standard of CareStandard of Care | Drug | Lumbar decompression without fusion (Outpatient Cohort), Open or mini-open surgical technique cohort, Tubular or Percutaneous cohort (Minimally Invasive Cohort) |
Primary outcome
Post-surgical Opioid Consumption in mg MED PO (0-72 Hours)
Time frame: 0-72 hours
Post-surgical opioid consumption in mg MED PO from 0 hours (end of surgery) to 72 hours postsurgery
2 secondary outcomes
Post-surgical Opioid Consumption in mg MED PO at 14 Days After Surgery
Time frame: 0-14 days after surgery
Time to First Opioid Rescue Through 72 Hours or Discharge.
Time frame: 0-72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gary Nevins, DC study director
Pacira Pharmaceuticals, Inc
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EXPAREL and Bupivacaine in people with Postoperative Pain Management, run by Pacira Pharmaceuticals, Inc at 12 sites 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 24 inclusion and 49 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: stopped early, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Yes. Results are posted in the registry (first posted 9 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-surgical Opioid Consumption in mg MED PO (0-72 Hours) (time frame: 0-72 hours). 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 9 Nov 2021.