Postoperative Pain ManagementPhase 4NCT03015961
Phase 4, Controlled Study in Adult Subjects Undergoing Primary, 1-2 Level, Open Lumbar Spinal Fusion Surgery
A Phase 4 study testing EXPAREL and bupivacaine HCl and Bupivacaine HCl in people with Postoperative Pain Management, run by Pacira Pharmaceuticals, Inc at 15 sites in United States.
Trial summary
Primary Objective: The primary objective of this study is to compare postsurgical pain control following local infiltration analgesia (LIA) with EXPAREL admixed with bupivacaine HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar posterior spinal fusion surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain Management
- What is being tested?
- EXPAREL and bupivacaine HCl and Bupivacaine HCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 15 sitesUnited States
- Study dates
- 21 Feb 2017to 30 Oct 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, at least 18 years of age at screening.
- Primary surgical indication is lumbar pain, radiculopathy, disc degeneration, disc herniation, foraminal stenosis, or 1-2 level spondylolisthesis or deformity.
- Scheduled to undergo primary, 1-2 level, open lumbar spinal fusion surgery under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
- Female subjects must be surgically sterile; or at least 2 years postmenopausal; or have a monogamous partner who is surgically sterile; or practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, or transdermal, contraceptive approved by the FDA for greater than 2 months prior to screening. All women of childbearing potential (ie, premenopausal without permanent sterilization) must commit to the use of an acceptable form of birth control for the duration of the study and for 30 days after completion of the study.
- Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.
Who cannot join
- Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
- Serious spinal conditions (to include cauda equina syndrome, infection, tumor, fracture, or severe osteoporosis [ie, if taking Bisphosphonate or TNF-α blockers]).
- Planned anterior or lateral incisions
- Previous spinal surgery at the same level other than microdiscectomy or hemilaminectomy (eg, bi-lateral laminectomy, fusion).
- Planned concurrent surgical procedure.
- Identification of a dural tear during surgery will be an intra-operative exclusion unless it is well repaired (no evidence of cerebrospinal fluid [CSF] leak with Valsalva and no plan to restrict activity post-operatively). Any injury to the nerve root occurring during surgery will also be considered an intra-operative exclusion.
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- Concurrent painful physical condition that may require analgesic treatment (such as an NSAID or opioid) in the postsurgical period for pain that is not strictly related to the spinal surgery and which may confound the postsurgical assessments.
- Comorbidity impacting current physical function or Investigator opinion that it may impact postsurgical rehabilitation.
- Allergy, hypersensitivity, or contraindication to any of the study medications (ie, bupivacaine, oxycodone, morphine, hydromorphone, gabapentin, acetaminophen, or cyclobenzaprine) for which an alternative medication is not provided in the protocol.
- Use of any of the following medications within the times specified before surgery: long-acting opioid medication (eg, morphine including MS Contin®, hydromorphone [Dilaudid®], oxycodone [Oxycontin®], methadone) daily for more than 3 months duration or within 3 days of surgery. Patients receiving short-acting opioids or NSAIDs should be at a steady or plateau dose. Such patients should require or receive no more than 40 mg morphine (oral) equivalents (eg, approximately 5 mg oxycodone) within 24 hours of surgery.
- Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), or duloxetine (Cymbalta®). If a subject is taking one of these medications for a reason other than pain control, he or she must be on a stable dose for at least 1 month prior to study drug administration.
- Current use of systemic glucocorticosteroids within 1 month of enrollment in this study.
- Use of dexmedetomidine HCl (Precedex®) within 3 days of study drug administration.
- History of coronary or vascular stent placed within the past 3 months (may be extended to 1 year if medically indicated per physician discretion).
- Have been treated for a deep vein thrombosis, pulmonary embolism, myocardial infarction, or ischemic stroke within the past 6 months (may be extended to 1 year if medically indicated per physician discretion).
- Severely impaired renal (eg, serum creatinine clearance ≤ 30) or hepatic function (eg, serum aspartate aminotransferase [AST] level >3 times the upper limit of normal [ULN] or serum alanine aminotransferase [ALT] level >3 x ULN).
- Any neurologic or psychiatric disorder that might impact postsurgical pain or interfere with study assessments.
- Malignancy in the last 2 years, per physician discretion.
- History of misuse, abuse, or dependence on opioid analgesics, other prescription drugs, illicit drugs, or alcohol as defined in DSM-IV. Dependence or chronic opioid use will be defined as use of more than 30 morphine equivalents per day during the prior 90 days.
- Failure to pass the alcohol breath test or urine drug screen positive for illicit drugs.
- Body weight <50 kg (110 pounds) or a body mass index >44 kg/m2.
- Subjects receiving Worker's compensation for a disability or who are involved in litigation.
- Previous participation in an EXPAREL study.
- Administration of an 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Central Texas Spine Institute
Austin, Texas, 78731
Massachusetts General Hospital
Boston, Massachusetts, 02114
OrthoCarolina
Charlotte, North Carolina, 28207
Univ of Virginia
Charlottesville, Virginia, 22903
Colonial Orthopaedics
Colonial Heights, Virginia, 23834
Ohio State Univ
Columbus, Ohio, 43210
OrthoArizona
Gilbert, Arizona, 85295
West Virginia University Hospitals
Morgantown, West Virginia, 26506
Icahn School of Medicine
New York, New York, 10029
Thomas Jefferson University of Neurosurgery
Philadelphia, Pennsylvania, 19107
St. Joseph's Hospital
Phoenix, Arizona, 85013
UC Davis
Sacramento, California, 95817
Washington Univ
St Louis, Missouri, 63110
Baylor Scott & White
Temple, Texas, 76508
Beaumont Health
Troy, Michigan, 48085
About this study
Official title: A Multicenter, Randomized, Double-Blind, Controlled Study of EXPAREL for Postsurgical Pain Management in Subjects Undergoing Open Lumbar Spinal Fusion Surgery
Primary Objective: The primary objective of this study is to compare postsurgical pain control following local infiltration analgesia (LIA) with EXPAREL admixed with bupivacaine HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar posterior spinal fusion surgery.
Secondary Objectives: The secondary objectives of this study are to compare additional efficacy, safety, and health economic outcomes following LIA with EXPAREL admixed with bupivacaine HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar posterior spinal fusion surgery.
Read the detailed description
This is a Phase 4, multicenter, randomized, double-blind, controlled study in 38 adult subjects undergoing primary, 1-2 level, open lumbar spinal fusion surgery under general anesthesia.
Subjects will be screened within 30 days prior to study drug administration and at least one day prior to surgery. During the screening visit, subjects will be assessed for past or present neurologic, cardiac, and general medical conditions that in the opinion of the Investigator would preclude them from study participation. After the informed consent form (ICF) is signed, a medical history, surgical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, select clinical laboratory evaluations, urine drug screen, alcohol breath test, and urine pregnancy test for women of childbearing potential will be conducted. Study drug, approximately 1-2 mL every 1.0-1.5 cm, will be administered using 20- or 22-gauge needles prior to wound closure.
Administration Instructions/Procedures
Study drug should be injected in the prescribed locations based on the areas of highest nerve density. Study drug will be administered using syringes with 20- or 22-gauge needles prior to wound closure. The Investigator must document the size of the incision. Each infiltration site should be spaced 1.0-1.5 cm apart and should deliver approximately 1-2 mL into both deep and superficial areas (para-spinous fascia, muscle, and subcutaneous layers). Total volume administered will be depended on the number of levels of dissection, as described below. Following infiltration, the tissue should visibly expand with minimal leakage.
Total Volume of Expansion
The Investigator must document the total volume used for each surgery.
- Level Procedures Group 1: EXPAREL 266 mg in 20 mL + bupivacaine HCl 0.5% in 20 mL + 20 mL normal saline = total volume of 60 mL Group 2: Bupivacaine HCl 0.5% in 20 mL + 40 mL normal saline = total volume of 60 mL
- Level Procedures Group 1: EXPAREL 266 mg in 20 mL + bupivacaine HCl 0.5% in 20 mL + 50 mL normal saline = total volume of 90 mL Group 2: Bupivacaine HCl 0.5% in 20 mL + 70 mL normal saline = total volume of 90 mL
Drains may be used at the surgeon's discretion. In addition to LIA, all study participants will receive a standardized approach for managing postsurgical pain that includes a scheduled multimodal pain regimen including adjunctive analgesics, non-steroidal anti-inflammatory drugs (NSAIDs). Rescue analgesics will be available as needed.
Postsurgical clinical assessments will include pain intensity scores using a 10-cm visual analog scale (VAS) (see Appendix 1); overall benefit of analgesia score (OBAS) questionnaire (see Appendix 2); total postsurgical opioid consumption; predefined opioid-related AEs; and nurse's satisfaction with overall analgesia (see Appendix 3).
Adverse events will be recorded from the time the ICF is signed through Day 30. If a cardiac AE (e.g., chest pain [angina, myocardial infarction], abnormal/irregular heart rate [bradycardia, tachycardia, extrasystoles], or shortness of breath), neurological AE (e.g., altered mental status/altered sensorium, dizziness, dysarthria, hyperesthesia, metallic taste, peroral numbness, seizure, tinnitus, tremors, visual disturbance, muscular twitching or rigidity beyond 72 hours postdose, or tingling/paresthesia beyond 72 hours postdose), or serious AE (SAE) occurs during the study a 12-lead ECG, vital signs, and any appropriate clinical laboratory tests should be conducted.
Postsurgical health economic outcome assessments will include hospital length of stay (LOS), use of skilled nursing facility, hospital readmissions, and use of other health services following discharge (phone calls related to postsurgical pain, unscheduled visits related to postsurgical pain, and visits to emergency department) through Day 30.
A follow-up visit will be scheduled for all subjects on postsurgical Day 14. A follow-up phone call will be made on Day 30 to all subjects who received study drug to assess for adverse events (AEs).
Number of Subjects (Planned):
Approximately 194 subjects are planned for enrollment in this study in order to have at least 184 evaluable subjects.
- Conditions
- Postoperative Pain Management
- Being tested
- EXPAREL and bupivacaine HCl, Bupivacaine HCl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXPAREL and bupivacaine HClDrug
Drug: EXPAREL EXPAREL and bupivacaine HCl
Other Name: bupivacaine liposome injectable suspension Drug: Bupivacaine Single dose of bupivacaine HCl 0.5%
Other Name: bupivacaine HCl
Bupivacaine HClDrug
Drug: Bupivacaine Single dose of bupivacaine HCl 0.5%
Other Name: bupivacaine HCl
| Study group | Role | What they receive |
|---|---|---|
| EXPAREL admixed with bupivacaine HCl | Active comparator | EXPAREL 266 mg + bupivacaine HCl Receives: Drug: EXPAREL and bupivacaine HCl |
| Bupivacaine HCl | Placebo comparator | Bupivacaine HCl Receives: Drug: Bupivacaine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) of Visual Analog Scale (VAS) Pain Intensity Scores From 0 to 72 Hours
AUC of VAS pain intensity scores from 0 to 72 hours postsurgery. Visual Analog Scale (VAS) is a pain scale. The VAS was presented as a straight 10 cm line, where 0 cm is no pain and 10 cm is the worst pain possible. Patients were asked, "How much pain are you experiencing right now? Please place a vertical mark on the line below to indicate the level of pain you are experiencing right now." AUC curve is derived using the trapezoidal rule (see formula below) on the pain scores. AUC start with the first pain assessment obtained after surgery and use all subsequent pain assessments up to 72 hours post-surgery. (Where pi is the VAS pain score at time i and ti is the time, in hours, from end of surgery. Note t1 is pain score collected after surgery.)
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 posted10 Jan 2017 (estimated)
- Study start21 Feb 2017
- Primary completion30 Oct 2017
- Study completion30 Oct 2017
Why it stopped: Slow enrollment
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015961
- Sponsor's protocol ID
- 402-C-409
- Status last verified
- Oct 2021
- First submitted
- 14 Nov 2016
- Last updated
- 13 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Controlled Study of EXPAREL for Postsurgical Pain Management in Subjects Undergoing Open Lumbar Spinal Fusion Surgery
- ClinicalTrials.gov ID
- NCT03015961
- Acronym / sponsor ID
- 402-C-409
- Conditions
- Postoperative Pain Management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Posted 13 Oct 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 pain control following local infiltration analgesia (LIA) with EXPAREL admixed with bupivacaine HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar posterior spinal fusion surgery.
Secondary Objectives: The secondary objectives of this study are to compare additional efficacy, safety, and health economic outcomes following LIA with EXPAREL admixed with bupivacaine HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar posterior spinal fusion surgery.
Detailed description
This is a Phase 4, multicenter, randomized, double-blind, controlled study in 38 adult subjects undergoing primary, 1-2 level, open lumbar spinal fusion surgery under general anesthesia.
Subjects will be screened within 30 days prior to study drug administration and at least one day prior to surgery. During the screening visit, subjects will be assessed for past or present neurologic, cardiac, and general medical conditions that in the opinion of the Investigator would preclude them from study participation. After the informed consent form (ICF) is signed, a medical history, surgical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, select clinical laboratory evaluations, urine drug screen, alcohol breath test, and urine pregnancy test for women of childbearing potential will be conducted. Study drug, approximately 1-2 mL every 1.0-1.5 cm, will be administered using 20- or 22-gauge needles prior to wound closure.
Administration Instructions/Procedures
Study drug should be injected in the prescribed locations based on the areas of highest nerve density. Study drug will be administered using syringes with 20- or 22-gauge needles prior to wound closure. The Investigator must document the size of the incision. Each infiltration site should be spaced 1.0-1.5 cm apart and should deliver approximately 1-2 mL into both deep and superficial areas (para-spinous fascia, muscle, and subcutaneous layers). Total volume administered will be depended on the number of levels of dissection, as described below. Following infiltration, the tissue should visibly expand with minimal leakage.
Total Volume of Expansion
The Investigator must document the total volume used for each surgery.
- Level Procedures Group 1: EXPAREL 266 mg in 20 mL + bupivacaine HCl 0.5% in 20 mL + 20 mL normal saline = total volume of 60 mL Group 2: Bupivacaine HCl 0.5% in 20 mL + 40 mL normal saline = total volume of 60 mL
- Level Procedures Group 1: EXPAREL 266 mg in 20 mL + bupivacaine HCl 0.5% in 20 mL + 50 mL normal saline = total volume of 90 mL Group 2: Bupivacaine HCl 0.5% in 20 mL + 70 mL normal saline = total volume of 90 mL
Drains may be used at the surgeon's discretion. In addition to LIA, all study participants will receive a standardized approach for managing postsurgical pain that includes a scheduled multimodal pain regimen including adjunctive analgesics, non-steroidal anti-inflammatory drugs (NSAIDs). Rescue analgesics will be available as needed.
Postsurgical clinical assessments will include pain intensity scores using a 10-cm visual analog scale (VAS) (see Appendix 1); overall benefit of analgesia score (OBAS) questionnaire (see Appendix 2); total postsurgical opioid consumption; predefined opioid-related AEs; and nurse's satisfaction with overall analgesia (see Appendix 3).
Adverse events will be recorded from the time the ICF is signed through Day 30. If a cardiac AE (e.g., chest pain [angina, myocardial infarction], abnormal/irregular heart rate [bradycardia, tachycardia, extrasystoles], or shortness of breath), neurological AE (e.g., altered mental status/altered sensorium, dizziness, dysarthria, hyperesthesia, metallic taste, peroral numbness, seizure, tinnitus, tremors, visual disturbance, muscular twitching or rigidity beyond 72 hours postdose, or tingling/paresthesia beyond 72 hours postdose), or serious AE (SAE) occurs during the study a 12-lead ECG, vital signs, and any appropriate clinical laboratory tests should be conducted.
Postsurgical health economic outcome assessments will include hospital length of stay (LOS), use of skilled nursing facility, hospital readmissions, and use of other health services following discharge (phone calls related to postsurgical pain, unscheduled visits related to postsurgical pain, and visits to emergency department) through Day 30.
A follow-up visit will be scheduled for all subjects on postsurgical Day 14. A follow-up phone call will be made on Day 30 to all subjects who received study drug to assess for adverse events (AEs).
Number of Subjects (Planned):
Approximately 194 subjects are planned for enrollment in this study in order to have at least 184 evaluable subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPAREL admixed with bupivacaine HCl | Active comparator | Drug: EXPAREL and bupivacaine HClEXPAREL 266 mg + bupivacaine HCl |
| Bupivacaine HCl | Placebo comparator | Drug: Bupivacaine HClBupivacaine HCl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, at least 18 years of age at screening.
- Primary surgical indication is lumbar pain, radiculopathy, disc degeneration, disc herniation, foraminal stenosis, or 1-2 level spondylolisthesis or deformity.
- Scheduled to undergo primary, 1-2 level, open lumbar spinal fusion surgery under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
- Female subjects must be surgically sterile; or at least 2 years postmenopausal; or have a monogamous partner who is surgically sterile; or practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, or transdermal, contraceptive approved by the FDA for greater than 2 months prior to screening. All women of childbearing potential (ie, premenopausal without permanent sterilization) must commit to the use of an acceptable form of birth control for the duration of the study and for 30 days after completion of the study.
Key exclusion criteria (24 listed)
- Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
- Serious spinal conditions (to include cauda equina syndrome, infection, tumor, fracture, or severe osteoporosis [ie, if taking Bisphosphonate or TNF-α blockers]).
- Planned anterior or lateral incisions
- Previous spinal surgery at the same level other than microdiscectomy or hemilaminectomy (eg, bi-lateral laminectomy, fusion).
- Planned concurrent surgical procedure.
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 bupivacaine HClDrug: EXPAREL EXPAREL and bupivacaine HCl Other Name: bupivacaine liposome injectable suspension Drug: Bupivacaine Single dose of bupivacaine HCl 0.5% Other Name: bupivacaine HCl | Drug | EXPAREL admixed with bupivacaine HCl |
| Bupivacaine HClDrug: Bupivacaine Single dose of bupivacaine HCl 0.5% Other Name: bupivacaine HCl | Drug | Bupivacaine HCl |
Primary outcome
Area Under the Curve (AUC) of Visual Analog Scale (VAS) Pain Intensity Scores From 0 to 72 Hours
Time frame: 0-72 hours
AUC of VAS pain intensity scores from 0 to 72 hours postsurgery. Visual Analog Scale (VAS) is a pain scale. The VAS was presented as a straight 10 cm line, where 0 cm is no pain and 10 cm is the worst pain possible. Patients were asked, "How much pain are you experiencing right now? Please place a vertical mark on the line below to indicate the level of pain you are experiencing right now." AUC curve is derived using the trapezoidal rule (see formula below) on the pain scores. AUC start with the first pain assessment obtained after surgery and use all subsequent pain assessments up to 72 hours post-surgery. (Where pi is the VAS pain score at time i and ti is the time, in hours, from end of surgery. Note t1 is pain score collected after surgery.)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
15 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 HCl and Bupivacaine HCl in people with Postoperative Pain Management, run by Pacira Pharmaceuticals, Inc at 15 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 6 inclusion and 24 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 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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. Some participants in this study may receive a placebo. 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 13 Oct 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?
Area Under the Curve (AUC) of Visual Analog Scale (VAS) Pain Intensity Scores From 0 to 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 13 Oct 2021; AzTrials last refreshed its copy on 31 Oct 2026.