PainPhase 4NCT02713490
Local Infiltration Analgesia With and Without EXPAREL Following Total Knee Arthroplasty
A Phase 4 study testing EXPAREL and Bupivacaine in people with Pain, run by Pacira Pharmaceuticals, Inc at 17 sites in United States.
Trial summary
This is a Phase 4, multicenter, randomized, double-blind, controlled trial in approximately 140 adult subjects undergoing primary unilateral TKA under spinal anesthesia with bupivacaine HCl (10-15 mg). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Pain
- What is being tested?
- EXPAREL and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 17 sitesUnited States
- Study dates
- 18 Apr 2016to 8 Feb 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, at least 18 years of age at screening.
- Scheduled to undergo primary, unilateral, tricompartmental TKA under spinal anesthesia.
- Primary indication for TKA is degenerative osteoarthritis of the knee.
- 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, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening and 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.
- History of previous prior contralateral TKA or open knee surgery on the knee being considered for TKA. Prior arthroscopy is permitted.
- Planned concurrent surgical procedure (e.g., bilateral TKA).
- Undergoing unicompartmental TKA or revision TKA.
- 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 knee surgery and which may confound the postsurgical assessments (e.g., significant pain from other joints including the non-index knee joint, chronic neuropathic pain, concurrent or prior contralateral TKA, concurrent foot surgery).
- Comorbidity impacting current physical function of Investigator opinion that it may impact postsurgical rehabilitation.
Show all 22Show fewer
- Allergy, hypersensitivity, or contraindication to any of the study medications (i.e., bupivacaine, pregabalin, acetaminophen/paracetamol, celecoxib, oxycodone, morphine, hydromorphone, or tranexamic acid).
- Use of any of the following medications within the times specified before surgery: long-acting opioid medication or NSAIDs (except for low-dose aspirin used for cardioprotection) within 3 days, or any opioid medication within 24 hours.
- 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), gabapentin, pregabalin (Lyrica®), 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).
- Rheumatoid or inflammatory arthritis or disease.
- Severely impaired renal or hepatic function (e.g., serum creatinine level >2 mg/dL [176.8 µmol/L], blood urea nitrogen level >50 mg/dL [17.9 mmol/L], serum aspartate aminotransferase [AST] level >3 times the upper limit of normal [ULN], or serum alanine aminotransferase [ALT] level >3 times the 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.
- Failure to pass the alcohol breath test or urine drug screen.
- Body weight <50 kg (110 pounds) or a body mass index >40 kg/m2.
- 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
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
UNC Orthopaedics Chapel Hill
Chapel Hill, North Carolina, 27599
OrthoCarolina, PA
Charlotte, North Carolina, 28207
Wellington Orthopaedics and Sports Medicine
Cincinnati, Ohio, 45209
Cleveland Clinic
Cleveland, Ohio, 44195
Holy Cross Hospital
Fort Lauderdale, Florida, 33334
San Antonio Military Medical Center
Fort Sam Houston, Texas, 78234
Institute for Joint Restoration
Fremont, California, 94538
Baylor Medical Center, Plano Orthopedics Sports Medical & Spine Center
Frisco, Texas, 75034
Loma Linda University
Loma Linda, California, 92354
Pinnacle Orthopaedics & Sports
Marietta, Georgia, 30060
NYU Hospital for Joint Disease
New York, New York, 10003
Lenox Hill Hospital/Northwell Health Orthopaedic Institute
New York, New York, 10075
Utah University Orthopedic Center
Salt Lake City, Utah, 84108
Orthopaedic Associates
Towson, Maryland, 21204
Cleveland Clinic Florida
Weston, Florida, 33331
Central DuPage Hospital, Northwestern Medicine
Winfield, Illinois, 60190
About this study
Official title: A Multicenter, Randomized, Double-Blind, Controlled Trial Comparing Local Infiltration Analgesia With EXPAREL to Local Infiltration Analgesia Without EXPAREL to Manage Postsurgical Pain Following Total Knee Arthroplasty
This is a Phase 4, multicenter, randomized, double-blind, controlled trial in approximately 140 adult subjects undergoing primary unilateral TKA under spinal anesthesia with bupivacaine HCl (10-15 mg).
Read the detailed description
On Day 0, eligible subjects will be randomized 1:1 to two treatment groups. Subjects in Group 1 will receive local infiltration analgesia (LIA) with EXPAREL 266 mg in 20 mL admixed with bupivacaine hydrochloride (HCl) 0.5% in 20 mL and expanded in volume with 80 mL normal saline (total volume of 120 mL). Subjects in Group 2 will receive LIA with bupivacaine HCl 0.5% in 20 mL expanded in volume with 100 mL normal saline (total volume of 120 mL). Investigators will use their usual surgical technique to perform the TKA.
Study drug will be administered using six 20 cc syringes with 22-gauge needles prior to wound closure. Each stick should deliver approximately 1-1.5 cc to the intended area. The tissue should visibly expand with minimal leakage. Study drug should be injected in the prescribed locations based on the areas of highest nerve density.
Infiltration Technique
Prior to cementation
Syringe #1: Posterior capsule (8-10 sticks medial and 8-10 sticks lateral).
Syringe #2: Femur medial and lateral periosteum, posterior periosteum, suprapatellar/quadriceps tendon (20 sticks).
Syringe #3: Tibia fat pad (5 sticks); pes anserinus, medial collateral ligament, and gutter (15 sticks).
Syringe #4: Circumferential periosteum (15-20 sticks).
After cementation
Syringe #5: Midline quadriceps tendon (10 sticks); retinaculum, medial gutter, femoral to tibia (10 sticks).
Syringe #6: Lateral gutter, femoral to tibial (10 sticks); subcutaneous/closure (10 sticks).
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), and rescue analgesics as needed.
Postsurgical clinical assessments will include pain intensity scores using a 10-cm visual analog scale (VAS); overall benefit of analgesia score (OBAS) questionnaire; total postsurgical opioid consumption; physical therapy assessment; nurse's satisfaction with overall analgesia; and discharge readiness. Adverse events (AEs) will be recorded from the time the informed consent form is signed through postsurgical Day 29.
Postsurgical health economic outcome assessments will include hospital length of stay (LOS), use of skilled nursing facility, outpatient physical therapy use, 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 postsurgical Day 29.
A follow-up visit will be scheduled for all subjects on postsurgical Day 14. A follow-up phone call will be made on postsurgical Day 29 to all subjects who received study drug to assess for AEs.
- Conditions
- Pain
- Being tested
- EXPAREL, Bupivacaine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXPARELDrug
Also called bupivacaine liposome injectable suspension
EXPAREL and bupivacaine HCl
BupivacaineDrug
Also called bupivacaine HCl
Single dose of bupivacaine HCl 0.5%
| Study group | Role | What they receive |
|---|---|---|
| EXPAREL | Active comparator | Single dose of EXPAREL 266 mg in 20 mL admixed with bupivacaine HCl 0.5% in 20 mL and expanded in volume with 80 mL normal saline (total volume of 120 mL). Receives: Drug: EXPAREL |
| Bupivacaine | Active comparator | Bupivacaine HCl 0.5% in 20 mL expanded in volume with 100 mL normal saline (total volume of 120 mL). Receives: Drug: Bupivacaine |
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 12 to 48 Hours
AUC of VAS pain intensity scores from 12 to 48 hours, which represents total pain experienced from 12 to 48 hours. 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."
Measured: From 12-48 hours
Total Postsurgical Opioid Consumption Through 48 Hours
Total postsurgical opioid consumption (converted to oral morphine equivalents) through 48 hours
Measured: 0-48 hours
Secondary outcomes (3)
Percentage of Opioid-free Subjects at 48 Hours
Measured: 48 hours
Time to First Opioid Rescue in the First 48 Hours
Time to first opioid rescue was estimated from Kaplan-Meier analysis and presented as quartiles (ie, time to rescue for the first 25% / 50% / 75% of subjects within each treatment group).
Measured: 48 hours
Overall Benefit of Analgesia Score at 48 Hours
The overall benefit of analgesic score (OBAS) comprises seven questions to assess pain intensity, adverse effects, and patients' satisfaction with analgesia (eg, "Please rate your current pain at rest on a scale between 0=minimal pain and 4=maximum imaginable pain"). Overall scores ranged between 0- 28. OBAS measures patients' benefit from postoperative pain therapy. A lower composite score indicates greater benefit from the therapy.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study start18 Apr 2016
- Primary completion8 Feb 2017
- Study completion8 Feb 2017
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James B Jones, MD, PharmD, Study director, Pacira Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713490
- Sponsor's protocol ID
- 402-C-331
- Status last verified
- Dec 2020
- First submitted
- 15 Mar 2016
- Last updated
- 11 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Dysart SH, Barrington JW, Del Gaizo DJ, Sodhi N, Mont MA. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Early Outcomes After Total Knee Arthroplasty: 24-Hour Data From the PILLAR Study. J Arthroplasty. 2019 May;34(5):882-886.e1. doi: 10.1016/j.arth.2018.12.026. Epub 2018 Dec 25.
PubMed 30799269Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Pain Scores and Reduces Opioid Use After Total Knee Arthroplasty: Results of a Randomized Controlled Trial. J Arthroplasty. 2018 Jan;33(1):90-96. doi: 10.1016/j.arth.2017.07.024. Epub 2017 Jul 25.
PubMed 28802777
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Controlled Trial Comparing Local Infiltration Analgesia With EXPAREL to Local Infiltration Analgesia Without EXPAREL to Manage Postsurgical Pain Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02713490
- Acronym / sponsor ID
- 402-C-331
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2016
- Primary completion
- 8 Feb 2017 (actual)
- Study completion
- 8 Feb 2017 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Posted 11 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 4, multicenter, randomized, double-blind, controlled trial in approximately 140 adult subjects undergoing primary unilateral TKA under spinal anesthesia with bupivacaine HCl (10-15 mg).
Detailed description
On Day 0, eligible subjects will be randomized 1:1 to two treatment groups. Subjects in Group 1 will receive local infiltration analgesia (LIA) with EXPAREL 266 mg in 20 mL admixed with bupivacaine hydrochloride (HCl) 0.5% in 20 mL and expanded in volume with 80 mL normal saline (total volume of 120 mL). Subjects in Group 2 will receive LIA with bupivacaine HCl 0.5% in 20 mL expanded in volume with 100 mL normal saline (total volume of 120 mL). Investigators will use their usual surgical technique to perform the TKA.
Study drug will be administered using six 20 cc syringes with 22-gauge needles prior to wound closure. Each stick should deliver approximately 1-1.5 cc to the intended area. The tissue should visibly expand with minimal leakage. Study drug should be injected in the prescribed locations based on the areas of highest nerve density.
Infiltration Technique
Prior to cementation
Syringe #1: Posterior capsule (8-10 sticks medial and 8-10 sticks lateral).
Syringe #2: Femur medial and lateral periosteum, posterior periosteum, suprapatellar/quadriceps tendon (20 sticks).
Syringe #3: Tibia fat pad (5 sticks); pes anserinus, medial collateral ligament, and gutter (15 sticks).
Syringe #4: Circumferential periosteum (15-20 sticks).
After cementation
Syringe #5: Midline quadriceps tendon (10 sticks); retinaculum, medial gutter, femoral to tibia (10 sticks).
Syringe #6: Lateral gutter, femoral to tibial (10 sticks); subcutaneous/closure (10 sticks).
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), and rescue analgesics as needed.
Postsurgical clinical assessments will include pain intensity scores using a 10-cm visual analog scale (VAS); overall benefit of analgesia score (OBAS) questionnaire; total postsurgical opioid consumption; physical therapy assessment; nurse's satisfaction with overall analgesia; and discharge readiness. Adverse events (AEs) will be recorded from the time the informed consent form is signed through postsurgical Day 29.
Postsurgical health economic outcome assessments will include hospital length of stay (LOS), use of skilled nursing facility, outpatient physical therapy use, 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 postsurgical Day 29.
A follow-up visit will be scheduled for all subjects on postsurgical Day 14. A follow-up phone call will be made on postsurgical Day 29 to all subjects who received study drug to assess for AEs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPAREL | Active comparator | Drug: EXPARELSingle dose of EXPAREL 266 mg in 20 mL admixed with bupivacaine HCl 0.5% in 20 mL and expanded in volume with 80 mL normal saline (total volume of 120 mL). |
| Bupivacaine | Active comparator | Drug: BupivacaineBupivacaine HCl 0.5% in 20 mL expanded in volume with 100 mL normal saline (total volume of 120 mL). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- 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.
- Scheduled to undergo primary, unilateral, tricompartmental TKA under spinal anesthesia.
- Primary indication for TKA is degenerative osteoarthritis of the knee.
- 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, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening and 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 (22 listed)
- Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
- History of previous prior contralateral TKA or open knee surgery on the knee being considered for TKA. Prior arthroscopy is permitted.
- Planned concurrent surgical procedure (e.g., bilateral TKA).
- Undergoing unicompartmental TKA or revision TKA.
- 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 knee surgery and which may confound the postsurgical assessments (e.g., significant pain from other joints including the non-index knee joint, chronic neuropathic pain, concurrent or prior contralateral TKA, concurrent foot surgery).
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 |
|---|---|---|
| EXPARELAlso: bupivacaine liposome injectable suspensionEXPAREL and bupivacaine HCl | Drug | EXPAREL |
| BupivacaineAlso: bupivacaine HClSingle dose of bupivacaine HCl 0.5% | Drug | Bupivacaine |
Primary outcome
Area Under The Curve (AUC) of Visual Analog Scale (VAS) Pain Intensity Scores From 12 to 48 Hours
Time frame: From 12-48 hours
AUC of VAS pain intensity scores from 12 to 48 hours, which represents total pain experienced from 12 to 48 hours. 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."
Total Postsurgical Opioid Consumption Through 48 Hours
Time frame: 0-48 hours
Total postsurgical opioid consumption (converted to oral morphine equivalents) through 48 hours
3 secondary outcomes
Percentage of Opioid-free Subjects at 48 Hours
Time frame: 48 hours
Time to First Opioid Rescue in the First 48 Hours
Time frame: 48 hours
Overall Benefit of Analgesia Score at 48 Hours
Time frame: 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30799269Dysart SH, Barrington JW, Del Gaizo DJ, Sodhi N, Mont MA. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Early Outcomes After Total Knee Arthroplasty: 24-Hour Data From the PILLAR Study. J Arthroplasty. 2019 May;34(5):882-886.e1. doi: 10.1016/j.arth.2018.12.026. Epub 2018 Dec 25.
- Derived from this study: PubMed 28802777Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Pain Scores and Reduces Opioid Use After Total Knee Arthroplasty: Results of a Randomized Controlled Trial. J Arthroplasty. 2018 Jan;33(1):90-96. doi: 10.1016/j.arth.2017.07.024. Epub 2017 Jul 25.
- Individual participant dataSharing planned: Undecided
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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.
James B Jones, MD, PharmD study director
Pacira Pharmaceuticals, Inc
17 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 Pain, run by Pacira Pharmaceuticals, Inc at 17 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 22 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: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 11 Dec 2020). 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 12 to 48 Hours (time frame: From 12-48 hours). 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?
On the ClinicalTrials.gov record for NCT02713490, which also lists 2 linked publications.
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 11 Dec 2020.