Tibial FracturesPhase 4NCT02951884
Intra-articular Local Anesthetic Injection and Hematoma Aspiration
A Phase 4 study testing Aspiration and Bupivacaine in people with Tibial Fractures, run by Loyola University at 1 site in United States.
Trial summary
The primary objective of this study is to determine whether a patient with a tibial plateau fracture (non-displaced, displaced, or depression type) will have decreased pain and narcotic analgesia requirements following an intra-articular injection of local anesthetic and aspiration of the knee. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tibial Fractures
- What is being tested?
- Aspiration and Bupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2016to 3 May 2018
- 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
- Patients with isolated tibial plateau fractures aged 18 years and older
- Patients with tibial plateau fractures and associated soft tissue complaints about the knee, not associated with a fracture outside of the tibial plateau
- Patients with bilateral tibial plateau fractures and no other noted fractures
Who cannot join
- Any patient that does not wish to participate in the study or is unable to give consent at the initial encounter
- Patients under 18 years old
- Pregnant patients
- Patients who are unable to understand the study procedures
- Incarcerated patients
- History of allergic reaction to local anesthetics
Show all 9Show fewer
- Emergent conditions requiring operations or airway protection
- Polytrauma patients
- Patients presenting for care greater than 24 hours following their injury.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
Official title: The Effect of Intra-articular Local Anesthetic Injection and Hematoma Aspiration on Pain and Narcotic Analgesia Use Following Tibial Plateau Fractures
The primary objective of this study is to determine whether a patient with a tibial plateau fracture (non-displaced, displaced, or depression type) will have decreased pain and narcotic analgesia requirements following an intra-articular injection of local anesthetic and aspiration of the knee.
Read the detailed description
We propose to study tibial plateau fractures treated at our institution for which we have fracture data, treated with open reduction internal fixation (ORIF) procedures or treated non-operatively. Patients will be identified based on the classification of their injury, that being tibial plateau fracture; we will seek to sub-classify each patient based on the Shatzker classification of tibial plateau fractures and using knee osteoarthritis (OA) classification as our prospective study will be based on both tibial plateau fractures as a whole and their sub-classification: Lateral tibial plateau fracture without depression (I), lateral tibial plateau fracture with depression (II), compression fracture of the lateral (IIIA) or central (IIIB) tibial plateau, medial tibial plateau fracture (IV), bicondylar tibial plateau fracture (V), and tibial plateau fracture with diaphyseal discontinuity (VI). It is important for our prospective study to classify each fracture pattern as they generally differ in energy of injury and thus may affect pain management or need for narcotic pain medications and also potentially affect functional outcomes.
Following consent for participation in the study, patients will be blinded to initial management of the tibial plateau fracture with either: Aspiration of the joint alone, aspiration of the knee joint and injection of 20cc bupivacaine 0.5% with 1:200,000 epinephrine, or no injection or aspiration therapy for a control arm. Using the block randomization list, the patient will be randomized at the time of consent for participation. For the sake of consistency, all participating treating physicians (orthopaedic on-call residents) will be trained on Sawbones Fully Encased Knee Joint with Patella and Ligaments for a standardized aspiration and injection technique.
For the patients randomized into the treatment arms, the knee will be held in 15-30 degrees short of full extension and fully prepped using chlorhexidine wipes in a centrifugal manner. An 18 gauge spinal needle will be introduced into the superolateral aspect of the knee (if the knee is too edematous, an inferolateral or inferomedial approach may be appropriate). We will aspirate the knee with a 60cc syringe until we are unable to draw out more fluid and record the volume on a case record form. Subsequently, we will remove the syringe from the needle connection, leaving the 18 gauge needle in place. Then we will draw up 30cc of 0.5% bupivacaine with 1:200,000 epinephrine (Marcaine) with .18-gauge needle into the second 60cc syringe. Subsequently, we will place the filled syringe on the 18 gauge needle already in the knee and inject. Then we will remove the needle-syringe construct and place a bandage over the injection site.
The patient's initial numerical rating scale (NRS) score will be recorded immediately. Subsequent visual analogue scale (VAS) scores will be recorded at 5 minutes after intervention and at hours 2, 4, 6, 8, 12, and 24 after initial work-up of the patient. Patients treated as an outpatient will record these values themselves. Patients will be directed to bring the completed form with them to their regular clinic follow-up visit. Additionally, supplemental analgesia requirements will be recorded upon administration and will be converted to morphine equivalent units for analysis. All patients admitted to the orthopedic service will be placed on patient-controlled analgesic (PCA) morphine, where the dose is determined by the weight of the patient. All other patients (those admitted to other services) will have analgesia converted to Opioid Morphine Equivalents (OMEs).
- Conditions
- Tibial Fractures
- Being tested
- Aspiration, Bupivacaine
- Keywords
- Aspiration, Bupivacaine, Epinephrine, Marcaine, Pain, Shin Bone
- Medical subject headings
- Tibial Fractures, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirationProcedure or surgery
A needle is placed into the knee joint and all of the blood that is in the joint is removed.
BupivacaineDrug
Also called Marcaine, Exparel, Sensorcaine
An injection of 20cc bupivacaine 0.5% with 1:200,00 epinephrine
| Study group | Role | What they receive |
|---|---|---|
| Aspiration | Experimental | Participants assigned to this arm receive aspiration of the joint alone in which a needle will be introduced into the knee joint to withdraw the blood that collects within the knee. Receives: Procedure: Aspiration |
| Aspiration with injection | Experimental | Participants assigned to this arm receive aspiration of the knee joint and an injection of 20cc bupivacaine 0.5% with 1:200,000 epinephrine Receives: Procedure: Aspiration; Drug: Bupivacaine |
| Control | No intervention | Participants assigned to this arm receive no injection or aspiration therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS) Pain Scores
Twenty-four hours after injury, patients will self report their numerical rating scale (NRS) score. The NRS score ranges from 0 to 10 with higher scores indicating greater pain.
Measured: 24 hours
Secondary outcomes (1)
Supplemental Analgesia
Twenty-four hours after injury, the researchers will record the number of participants that required supplemental analgesia.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start15 Jun 2016
- Primary completion3 May 2018
- Study completion3 May 2018
Why it stopped: The study was stopped for feasibility (low 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.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Tibial FracturesStudies 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
- Participants will be randomized to receive aspiration of the joint alone, receive aspiration of the knee joint and an injection of 20cc bupivacaine 0.5% with 1:200,000 epinephrine, or receive no injection or aspiration therapy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Lack, Loyola University
- Investigators
- William Lack, MD, Principal investigator, Loyola University Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951884
- Sponsor's protocol ID
- 208755
- Status last verified
- Aug 2018
- First submitted
- 28 Oct 2016
- Last updated
- 17 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers
Publications
Manidakis N, Dosani A, Dimitriou R, Stengel D, Matthews S, Giannoudis P. Tibial plateau fractures: functional outcome and incidence of osteoarthritis in 125 cases. Int Orthop. 2010 Apr;34(4):565-70. doi: 10.1007/s00264-009-0790-5. Epub 2009 May 14. No abstract available.
PubMed 19440710Koval KJ, Helfet DL. Tibial Plateau Fractures: Evaluation and Treatment. J Am Acad Orthop Surg. 1995 Mar;3(2):86-94. doi: 10.5435/00124635-199503000-00004.
PubMed 10790657Stein C, Comisel K, Haimerl E, Yassouridis A, Lehrberger K, Herz A, Peter K. Analgesic effect of intraarticular morphine after arthroscopic knee surgery. N Engl J Med. 1991 Oct 17;325(16):1123-6. doi: 10.1056/NEJM199110173251602.
PubMed 1653901Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63. doi: 10.2106/JBJS.E.00344.
PubMed 16651569Franceschi F, Rizzello G, Cataldo R, Denaro V. Comparison of morphine and ropivacaine following knee arthroscopy. Arthroscopy. 2001 May;17(5):477-80. doi: 10.1053/jars.2001.19684.
PubMed 11337713Jaureguito JW, Wilcox JF, Cohn SJ, Thisted RA, Reider B. A comparison of intraarticular morphine and bupivacaine for pain control after outpatient knee arthroscopy. A prospective, randomized, double-blinded study. Am J Sports Med. 1995 May-Jun;23(3):350-3. doi: 10.1177/036354659502300318.
PubMed 7661266White BJ, Walsh M, Egol KA, Tejwani NC. Intra-articular block compared with conscious sedation for closed reduction of ankle fracture-dislocations. A prospective randomized trial. J Bone Joint Surg Am. 2008 Apr;90(4):731-4. doi: 10.2106/JBJS.G.00733.
PubMed 18381308Perdreau A, Joudet T. Efficacy of multimodal analgesia injection combined with corticosteroids after arthroscopic rotator cuff repair. Orthop Traumatol Surg Res. 2015 Dec;101(8 Suppl):S337-45. doi: 10.1016/j.otsr.2015.09.006. Epub 2015 Nov 10.
PubMed 26563923Chalidis BE, Papadopoulos PP, Sachinis NC, Dimitriou CG. Aspiration alone versus aspiration and bupivacaine injection in the treatment of undisplaced radial head fractures: a prospective randomized study. J Shoulder Elbow Surg. 2009 Sep-Oct;18(5):676-9. doi: 10.1016/j.jse.2009.04.003. Epub 2009 May 31.
PubMed 19487135Ditsios KT, Stavridis SI, Christodoulou AG. The effect of haematoma aspiration on intra-articular pressure and pain relief following Mason I radial head fractures. Injury. 2011 Apr;42(4):362-5. doi: 10.1016/j.injury.2010.09.003. Epub 2010 Oct 8.
PubMed 20932520Bijur PE, Latimer CT, Gallagher EJ. Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department. Acad Emerg Med. 2003 Apr;10(4):390-2. doi: 10.1111/j.1553-2712.2003.tb01355.x.
PubMed 12670856Heard SO, Edwards WT, Ferrari D, Hanna D, Wong PD, Liland A, Willock MM. Analgesic effect of intraarticular bupivacaine or morphine after arthroscopic knee surgery: a randomized, prospective, double-blind study. Anesth Analg. 1992 Jun;74(6):822-6. doi: 10.1213/00000539-199206000-00008.
PubMed 1595914Badner NH, Bourne RB, Rorabeck CH, MacDonald SJ, Doyle JA. Intra-articular injection of bupivacaine in knee-replacement operations. Results of use for analgesia and for preemptive blockade. J Bone Joint Surg Am. 1996 May;78(5):734-8. doi: 10.2106/00004623-199605000-00013.
PubMed 8642030
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intra-articular Local Anesthetic Injection and Hematoma Aspiration on Pain and Narcotic Analgesia Use Following Tibial Plateau Fractures
- ClinicalTrials.gov ID
- NCT02951884
- Acronym / sponsor ID
- 208755
- Conditions
- Tibial Fractures
- Keywords
- Aspiration, Bupivacaine, Epinephrine, Marcaine, Pain, Shin Bone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped for feasibility (low enrollment)
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 3 May 2018 (actual)
- Study completion
- 3 May 2018 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Posted 17 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine whether a patient with a tibial plateau fracture (non-displaced, displaced, or depression type) will have decreased pain and narcotic analgesia requirements following an intra-articular injection of local anesthetic and aspiration of the knee.
Detailed description
We propose to study tibial plateau fractures treated at our institution for which we have fracture data, treated with open reduction internal fixation (ORIF) procedures or treated non-operatively. Patients will be identified based on the classification of their injury, that being tibial plateau fracture; we will seek to sub-classify each patient based on the Shatzker classification of tibial plateau fractures and using knee osteoarthritis (OA) classification as our prospective study will be based on both tibial plateau fractures as a whole and their sub-classification: Lateral tibial plateau fracture without depression (I), lateral tibial plateau fracture with depression (II), compression fracture of the lateral (IIIA) or central (IIIB) tibial plateau, medial tibial plateau fracture (IV), bicondylar tibial plateau fracture (V), and tibial plateau fracture with diaphyseal discontinuity (VI). It is important for our prospective study to classify each fracture pattern as they generally differ in energy of injury and thus may affect pain management or need for narcotic pain medications and also potentially affect functional outcomes.
Following consent for participation in the study, patients will be blinded to initial management of the tibial plateau fracture with either: Aspiration of the joint alone, aspiration of the knee joint and injection of 20cc bupivacaine 0.5% with 1:200,000 epinephrine, or no injection or aspiration therapy for a control arm. Using the block randomization list, the patient will be randomized at the time of consent for participation. For the sake of consistency, all participating treating physicians (orthopaedic on-call residents) will be trained on Sawbones Fully Encased Knee Joint with Patella and Ligaments for a standardized aspiration and injection technique.
For the patients randomized into the treatment arms, the knee will be held in 15-30 degrees short of full extension and fully prepped using chlorhexidine wipes in a centrifugal manner. An 18 gauge spinal needle will be introduced into the superolateral aspect of the knee (if the knee is too edematous, an inferolateral or inferomedial approach may be appropriate). We will aspirate the knee with a 60cc syringe until we are unable to draw out more fluid and record the volume on a case record form. Subsequently, we will remove the syringe from the needle connection, leaving the 18 gauge needle in place. Then we will draw up 30cc of 0.5% bupivacaine with 1:200,000 epinephrine (Marcaine) with .18-gauge needle into the second 60cc syringe. Subsequently, we will place the filled syringe on the 18 gauge needle already in the knee and inject. Then we will remove the needle-syringe construct and place a bandage over the injection site.
The patient's initial numerical rating scale (NRS) score will be recorded immediately. Subsequent visual analogue scale (VAS) scores will be recorded at 5 minutes after intervention and at hours 2, 4, 6, 8, 12, and 24 after initial work-up of the patient. Patients treated as an outpatient will record these values themselves. Patients will be directed to bring the completed form with them to their regular clinic follow-up visit. Additionally, supplemental analgesia requirements will be recorded upon administration and will be converted to morphine equivalent units for analysis. All patients admitted to the orthopedic service will be placed on patient-controlled analgesic (PCA) morphine, where the dose is determined by the weight of the patient. All other patients (those admitted to other services) will have analgesia converted to Opioid Morphine Equivalents (OMEs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants will be randomized to receive aspiration of the joint alone, receive aspiration of the knee joint and an injection of 20cc bupivacaine 0.5% with 1:200,000 epinephrine, or receive no injection or aspiration therapy
| Arm | Type | Receives |
|---|---|---|
| Aspiration | Experimental | Procedure: AspirationParticipants assigned to this arm receive aspiration of the joint alone in which a needle will be introduced into the knee joint to withdraw the blood that collects within the knee. |
| Aspiration with injection | Experimental | Procedure: Aspiration, Drug: BupivacaineParticipants assigned to this arm receive aspiration of the knee joint and an injection of 20cc bupivacaine 0.5% with 1:200,000 epinephrine |
| Control | No intervention | –Participants assigned to this arm receive no injection or aspiration therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with isolated tibial plateau fractures aged 18 years and older
- Patients with tibial plateau fractures and associated soft tissue complaints about the knee, not associated with a fracture outside of the tibial plateau
- Patients with bilateral tibial plateau fractures and no other noted fractures
Key exclusion criteria (9 listed)
- Any patient that does not wish to participate in the study or is unable to give consent at the initial encounter
- Patients under 18 years old
- Pregnant patients
- Patients who are unable to understand the study procedures
- Incarcerated patients
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 |
|---|---|---|
| AspirationA needle is placed into the knee joint and all of the blood that is in the joint is removed. | Procedure or surgery | Aspiration, Aspiration with injection |
| BupivacaineAlso: Marcaine, Exparel, SensorcaineAn injection of 20cc bupivacaine 0.5% with 1:200,00 epinephrine | Drug | Aspiration with injection |
Primary outcome
Numerical Rating Scale (NRS) Pain Scores
Time frame: 24 hours
Twenty-four hours after injury, patients will self report their numerical rating scale (NRS) score. The NRS score ranges from 0 to 10 with higher scores indicating greater pain.
1 secondary outcome
Supplemental Analgesia
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19440710Manidakis N, Dosani A, Dimitriou R, Stengel D, Matthews S, Giannoudis P. Tibial plateau fractures: functional outcome and incidence of osteoarthritis in 125 cases. Int Orthop. 2010 Apr;34(4):565-70. doi: 10.1007/s00264-009-0790-5. Epub 2009 May 14. No abstract available.
- Background: PubMed 10790657Koval KJ, Helfet DL. Tibial Plateau Fractures: Evaluation and Treatment. J Am Acad Orthop Surg. 1995 Mar;3(2):86-94. doi: 10.5435/00124635-199503000-00004.
- Background: PubMed 1653901Stein C, Comisel K, Haimerl E, Yassouridis A, Lehrberger K, Herz A, Peter K. Analgesic effect of intraarticular morphine after arthroscopic knee surgery. N Engl J Med. 1991 Oct 17;325(16):1123-6. doi: 10.1056/NEJM199110173251602.
- Background: PubMed 16651569Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63. doi: 10.2106/JBJS.E.00344.
- Background: PubMed 11337713Franceschi F, Rizzello G, Cataldo R, Denaro V. Comparison of morphine and ropivacaine following knee arthroscopy. Arthroscopy. 2001 May;17(5):477-80. doi: 10.1053/jars.2001.19684.
- Background: PubMed 7661266Jaureguito JW, Wilcox JF, Cohn SJ, Thisted RA, Reider B. A comparison of intraarticular morphine and bupivacaine for pain control after outpatient knee arthroscopy. A prospective, randomized, double-blinded study. Am J Sports Med. 1995 May-Jun;23(3):350-3. doi: 10.1177/036354659502300318.
- Background: PubMed 18381308White BJ, Walsh M, Egol KA, Tejwani NC. Intra-articular block compared with conscious sedation for closed reduction of ankle fracture-dislocations. A prospective randomized trial. J Bone Joint Surg Am. 2008 Apr;90(4):731-4. doi: 10.2106/JBJS.G.00733.
- Background: PubMed 26563923Perdreau A, Joudet T. Efficacy of multimodal analgesia injection combined with corticosteroids after arthroscopic rotator cuff repair. Orthop Traumatol Surg Res. 2015 Dec;101(8 Suppl):S337-45. doi: 10.1016/j.otsr.2015.09.006. Epub 2015 Nov 10.
- Background: PubMed 19487135Chalidis BE, Papadopoulos PP, Sachinis NC, Dimitriou CG. Aspiration alone versus aspiration and bupivacaine injection in the treatment of undisplaced radial head fractures: a prospective randomized study. J Shoulder Elbow Surg. 2009 Sep-Oct;18(5):676-9. doi: 10.1016/j.jse.2009.04.003. Epub 2009 May 31.
- Background: PubMed 20932520Ditsios KT, Stavridis SI, Christodoulou AG. The effect of haematoma aspiration on intra-articular pressure and pain relief following Mason I radial head fractures. Injury. 2011 Apr;42(4):362-5. doi: 10.1016/j.injury.2010.09.003. Epub 2010 Oct 8.
- Background: PubMed 12670856Bijur PE, Latimer CT, Gallagher EJ. Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department. Acad Emerg Med. 2003 Apr;10(4):390-2. doi: 10.1111/j.1553-2712.2003.tb01355.x.
- Background: PubMed 1595914Heard SO, Edwards WT, Ferrari D, Hanna D, Wong PD, Liland A, Willock MM. Analgesic effect of intraarticular bupivacaine or morphine after arthroscopic knee surgery: a randomized, prospective, double-blind study. Anesth Analg. 1992 Jun;74(6):822-6. doi: 10.1213/00000539-199206000-00008.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers
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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.
William Lack, MD principal investigator
Loyola University Chicago
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 Aspiration and Bupivacaine in people with Tibial Fractures, run by Loyola University 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 3 inclusion and 9 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 17 Aug 2018. 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?
Yes. Results are posted in the registry (first posted 17 Aug 2018). 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?
Numerical Rating Scale (NRS) Pain Scores (time frame: 24 hours). 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 NCT02951884, which also lists 13 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 17 Aug 2018.