Hand InjuriesNCT03195413
Early Ultrasound-guided Nerve Block for Painful Hand Injuries in the Emergency Department
A study testing Ultrasound-guided forearm nerve block, 1:1 volume measured solution of: 1% lidocaine without epinephrine and 0.5% bupivacaine without epinephrine and Bedside ultrasound machine in people with Hand Injuries and Hand Injuries and Disorders, run by University of Washington at 1 site in United States.
Trial summary
This study aims to determine whether early initiation of temporary nerve block therapy improves patient satisfaction, decreases patient pain and discomfort, decreases the use of dangerous medications such as narcotics, and frees hospital resources. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hand Injuries, Hand Injuries and Disorders
- What is being tested?
- Ultrasound-guided forearm nerve block, 1:1 volume measured solution of: 1% lidocaine without epinephrine and 0.5% bupivacaine without epinephrine and Bedside ultrasound machine
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 10 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient with moderate to severe hand blast injury or other significantly painful hand or distal forearm injury Also, patients who...
- Are awake and alert
- Are able to endorse or rate their pain
- Require intravenous pain medication for their hand injury
- Are determined to be clinically sober for consent. They will need to be fluent of speech and able to articulate understanding of the procedure they will undergo and the study they will enter.
Who cannot join
- Patient's who...
- Require surgical management, within one half hour, for any injury
- Require any emergent care, including resuscitation, the should preclude their regional pain management
- Are hemodynamically unstable
- Have signs of coagulopathy
- Have clinical features suggestive of compartment syndrome of the forearm, including:
Show all 15Show fewer
- Tense or firm forearm compartment
- Expanding hematoma
- Regional neurologic deficit (weakness or numbness)
- Have weakness or a sensory deficit in an intact part of their hand or forearm
- Have a vascular injury proximal to the hand
- Are unconscious or otherwise unable to endorse or rate their pain
- Are not deemed clinically sober enough to articulate an understanding of the procedure they will undergo and the study they will enter.
- Are prisoners
- Are <18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center / University of Washington
Seattle, Washington, 98104
About this study
This study aims to determine whether early initiation of temporary nerve block therapy improves patient satisfaction, decreases patient pain and discomfort, decreases the use of dangerous medications such as narcotics, and frees hospital resources. Hand injuries, such as blast injuries from fireworks, can be very painful. In the emergency department, providers generally use narcotic pain medications to control pain, but these have significant side effects. It is possible that temporary nerve blocks, guided by ultrasound, can be safe and useful in the emergency department. They have been shown to be effective in several studies around the country. The goal of this study is to build on the experience of others to increase the use of US-guided regional nerve blocks as a form of pain management in hand and distal forearm injuries in the Harborview Medical Center (HMC) emergency department. By working with a multidisciplinary team, the study investigators hope to use this technique to decrease narcotic use and improve pain control, and to provide important data for Emergency Medicine physicians elsewhere who are considering incorporating this nerve block technique into their practice.
Read the detailed description
Hand and forearm pain secondary to fracture, laceration, dislocation, infection, and blast injury is a common issue in the emergency department (ED). Pain control is particularly important in these patients as they frequently require manipulation of their injured extremity for suturing, reduction, splinting, or abscess drainage. Pain management has traditionally centered on the use of parenteral narcotics. These medications can have significant side effects, especially in the elderly and those with comorbid diseases, and may not provide sufficient pain control in these cases, specifically in those with opioid tolerance or gruesome blast injuries. Regional nerve blocks have proven a useful tool in the management of extremity pain but have been traditionally limited to use by anesthesiologists in order to limit side effects such as intravascular infiltration and nerve damage. However, the use of direct visualization with ultrasound (US) can minimize these risks and emergency medicine (EM) physicians are using nerve blocks with increasing frequency. Recent emergency medicine literature has been promising with regard to the successful use of US-guided regional nerve blocks for finger reduction, upper extremity fractures, dislocations, abscess drainage, and hand blast injuries in the emergency department. In one case series, nerve blocks were used successfully in pediatric patients and studies measuring feasibility have found that these blocks can be done in less than ten minutes, and without significant complications. However, more studies are needed before these blocks become standard of care in all institutions. Studies that evaluate the use of other pain medications in the setting of these blocks would be particularly helpful.
Academic institutions are using US-guided nerve blocks with increasing frequency. In a recent publication 121 academic instructions provided information on usage of this technique. 84% of programs perform US-guided nerve blocks, most commonly forearm nerve blocks (ulnar, median, or radial nerves). Nerve block technique is taught via didactic sessions, online resources, and supervised training. However, most of the programs do not have specific agreements with other specialty services with regard to performing US-guided nerve blocks in the ED. One group has successfully created a multidisciplinary approach to treat blast injuries to the hand which includes EM physicians and surgeons. This team recognized the importance of surgical evaluation prior to nerve block in blast injuries to assess for risk of compartment syndrome. No cases of compartment syndrome were reported in this case series and pain control provided by the nerve block allowed the surgical team to evaluate the extent of injuries, irrigate the wound thoroughly, and employ temporizing measures such as sutures and splints while the patient waited for definitive management.
However, this aforementioned study was inherently limited in that it was a feasibility study. While promising, further work that establishes forearm blocks by ED physicians in the setting of severe hand injuries as safe and effective can guide us as to whether this mode of pain management should be standard of care. A major goal of this study will be to provide important data for emergency physicians when they consider whether or not to include these blocks into their practice.
To that end, the study investigators present a randomized controlled trial where patients with blast injuries will be randomized to standard-of-care versus early ultrasound-guided nerve block as an intervention. Measured outcomes will include pain scores, complications, and opioid use.
- Conditions
- Hand Injuries, Hand Injuries and Disorders
- Being tested
- Ultrasound-guided forearm nerve block, 1:1 volume measured solution of: 1% lidocaine without epinephrine and 0.5% bupivacaine without epinephrine, Bedside ultrasound machine
- Keywords
- Hand blast injury, Nerve block, Hand injury, Forearm nerve block, Ultrasound guided nerve block, Ultrasound nerve block, Emergency department, Emergency physician, Emergency room
- Medical subject headings
- Hand Injuries, Disease, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided forearm nerve blockProcedure or surgery
Also called Nerve block
An ultrasound machine will be used to identify the median, radial, and ulnar nerves in the forearm, so that a needle may be used to apply lidocaine into the soft tissue space around those nerves.
1:1 volume measured solution of: 1% lidocaine without epinephrine and 0.5% bupivacaine without epinephrineDrug
This is the anesthetic solution that will be administered during the ultrasound-guided nerve block
Bedside ultrasound machineDevice
This is the device that will be used to visualize tissues during the ultrasound-guided nerve block.
| Study group | Role | What they receive |
|---|---|---|
| Nerve Block Arm | Experimental | This group of patients will receive an ultrasound-guided forearm block intervention by the study team. The nerve block will be achieved with a solution of 1% lidocaine without epinephrine and 0.5% bupivacaine without epinephrine (mixed in a 1:1 volume ratio) dosed once. A second dose will be given only in the case of complete block failure. Receives: Procedure: Ultrasound-guided forearm nerve block; Drug: 1:1 volume measured solution of: 1% lidocaine without epinephrine and 0.5% bupivacaine without epinephrine; Device: Bedside ultrasound machine |
| Control Arm | No intervention | This group will receive the standard of care in our emergency department, as determined by their primary team. If a patient here receives a nerve block from the primary team, they will be handled with intention-to-treat analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score (1-100 visual or verbal scale)
Pain score (1-100 visual or verbal scale) at 3 hours post-block
Measured: 3 hour
Secondary outcomes (3)
Complications
Complications from the nerve blocks (i.e. compartment syndrome, persistent nerve symptoms) will be measured on follow up.
Measured: 4 weeks
Opioid medication use
The amount (in morphine equivalents) number of doses of opioid medications used in the emergency department will be measured.
Measured: 1 day
Additional pain scores (1-100 visual or verbal scale)
Pain scores (1-100 visual or verbal scale) at time of block, 15 minutes after block, and one hour after block, and 2 hours after block.
Measured: 0 - 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start1 Jul 2017
- Primary completion10 Jul 2018
- Study completion10 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arvin Akhavan, University of Washington
- Investigators
- Michael Vrablik, DO, Study director, University of Washington Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195413
- Sponsor's protocol ID
- STUDY00001627
- Status last verified
- Oct 2018
- First submitted
- 17 Jun 2017
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chung KC, Spilson SV. The frequency and epidemiology of hand and forearm fractures in the United States. J Hand Surg Am. 2001 Sep;26(5):908-15. doi: 10.1053/jhsu.2001.26322.
PubMed 11561245Patanwala AE, Keim SM, Erstad BL. Intravenous opioids for severe acute pain in the emergency department. Ann Pharmacother. 2010 Nov;44(11):1800-9. doi: 10.1345/aph.1P438. Epub 2010 Oct 26.
PubMed 20978218Williams SR, Chouinard P, Arcand G, Harris P, Ruel M, Boudreault D, Girard F. Ultrasound guidance speeds execution and improves the quality of supraclavicular block. Anesth Analg. 2003 Nov;97(5):1518-1523. doi: 10.1213/01.ANE.0000086730.09173.CA.
PubMed 14570678Marhofer P, Greher M, Kapral S. Ultrasound guidance in regional anaesthesia. Br J Anaesth. 2005 Jan;94(1):7-17. doi: 10.1093/bja/aei002. Epub 2004 Jul 26.
PubMed 15277302Witwicki T, Dziak A. [Sarcomatous degeneration in the course of Recklinghausen's neurofibromatosis]. Chir Narzadow Ruchu Ortop Pol. 1969;34(6):809-11. No abstract available. Polish.
PubMed 4983335Stone MB, Price DD, Wang R. Ultrasound-guided supraclavicular block for the treatment of upper extremity fractures, dislocations, and abscesses in the ED. Am J Emerg Med. 2007 May;25(4):472-5. doi: 10.1016/j.ajem.2006.08.019.
PubMed 17499669Wroe P, O'Shea R, Johnson B, Hoffman R, Nagdev A. Ultrasound-guided forearm nerve blocks for hand blast injuries: case series and multidisciplinary protocol. Am J Emerg Med. 2016 Sep;34(9):1895-7. doi: 10.1016/j.ajem.2016.06.111. Epub 2016 Jul 11. No abstract available.
PubMed 27461885Frenkel O, Liebmann O, Fischer JW. Ultrasound-guided forearm nerve blocks in kids: a novel method for pain control in the treatment of hand-injured pediatric patients in the emergency department. Pediatr Emerg Care. 2015 Apr;31(4):255-9. doi: 10.1097/PEC.0000000000000398.
PubMed 25803747Liebmann O, Price D, Mills C, Gardner R, Wang R, Wilson S, Gray A. Feasibility of forearm ultrasonography-guided nerve blocks of the radial, ulnar, and median nerves for hand procedures in the emergency department. Ann Emerg Med. 2006 Nov;48(5):558-62. doi: 10.1016/j.annemergmed.2006.04.014. Epub 2006 Jun 14.
PubMed 17052557Amini R, Kartchner JZ, Nagdev A, Adhikari S. Ultrasound-Guided Nerve Blocks in Emergency Medicine Practice. J Ultrasound Med. 2016 Apr;35(4):731-6. doi: 10.7863/ultra.15.05095. Epub 2016 Mar 1.
PubMed 26931789
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Ultrasound-guided Nerve Block for Painful Hand Injuries in the Emergency Department
- ClinicalTrials.gov ID
- NCT03195413
- Acronym / sponsor ID
- STUDY00001627
- Conditions
- Hand Injuries, Hand Injuries and Disorders
- Keywords
- Hand blast injury, Nerve block, Hand injury, Forearm nerve block, Ultrasound guided nerve block, Ultrasound nerve block, Emergency department, Emergency physician
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 10 Jul 2018 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine whether early initiation of temporary nerve block therapy improves patient satisfaction, decreases patient pain and discomfort, decreases the use of dangerous medications such as narcotics, and frees hospital resources. Hand injuries, such as blast injuries from fireworks, can be very painful. In the emergency department, providers generally use narcotic pain medications to control pain, but these have significant side effects. It is possible that temporary nerve blocks, guided by ultrasound, can be safe and useful in the emergency department. They have been shown to be effective in several studies around the country. The goal of this study is to build on the experience of others to increase the use of US-guided regional nerve blocks as a form of pain management in hand and distal forearm injuries in the Harborview Medical Center (HMC) emergency department. By working with a multidisciplinary team, the study investigators hope to use this technique to decrease narcotic use and improve pain control, and to provide important data for Emergency Medicine physicians elsewhere who are considering incorporating this nerve block technique into their practice.
Detailed description
Hand and forearm pain secondary to fracture, laceration, dislocation, infection, and blast injury is a common issue in the emergency department (ED). Pain control is particularly important in these patients as they frequently require manipulation of their injured extremity for suturing, reduction, splinting, or abscess drainage. Pain management has traditionally centered on the use of parenteral narcotics. These medications can have significant side effects, especially in the elderly and those with comorbid diseases, and may not provide sufficient pain control in these cases, specifically in those with opioid tolerance or gruesome blast injuries. Regional nerve blocks have proven a useful tool in the management of extremity pain but have been traditionally limited to use by anesthesiologists in order to limit side effects such as intravascular infiltration and nerve damage. However, the use of direct visualization with ultrasound (US) can minimize these risks and emergency medicine (EM) physicians are using nerve blocks with increasing frequency. Recent emergency medicine literature has been promising with regard to the successful use of US-guided regional nerve blocks for finger reduction, upper extremity fractures, dislocations, abscess drainage, and hand blast injuries in the emergency department. In one case series, nerve blocks were used successfully in pediatric patients and studies measuring feasibility have found that these blocks can be done in less than ten minutes, and without significant complications. However, more studies are needed before these blocks become standard of care in all institutions. Studies that evaluate the use of other pain medications in the setting of these blocks would be particularly helpful.
Academic institutions are using US-guided nerve blocks with increasing frequency. In a recent publication 121 academic instructions provided information on usage of this technique. 84% of programs perform US-guided nerve blocks, most commonly forearm nerve blocks (ulnar, median, or radial nerves). Nerve block technique is taught via didactic sessions, online resources, and supervised training. However, most of the programs do not have specific agreements with other specialty services with regard to performing US-guided nerve blocks in the ED. One group has successfully created a multidisciplinary approach to treat blast injuries to the hand which includes EM physicians and surgeons. This team recognized the importance of surgical evaluation prior to nerve block in blast injuries to assess for risk of compartment syndrome. No cases of compartment syndrome were reported in this case series and pain control provided by the nerve block allowed the surgical team to evaluate the extent of injuries, irrigate the wound thoroughly, and employ temporizing measures such as sutures and splints while the patient waited for definitive management.
However, this aforementioned study was inherently limited in that it was a feasibility study. While promising, further work that establishes forearm blocks by ED physicians in the setting of severe hand injuries as safe and effective can guide us as to whether this mode of pain management should be standard of care. A major goal of this study will be to provide important data for emergency physicians when they consider whether or not to include these blocks into their practice.
To that end, the study investigators present a randomized controlled trial where patients with blast injuries will be randomized to standard-of-care versus early ultrasound-guided nerve block as an intervention. Measured outcomes will include pain scores, complications, and opioid use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nerve Block Arm | Experimental | Procedure: Ultrasound-guided forearm nerve block, Drug: 1:1 volume measured solution of: 1% lidocaine without epinephrine and 0.5% bupivacaine without epinephrine, Device: Bedside ultrasound machineThis group of patients will receive an ultrasound-guided forearm block intervention by the study team. The nerve block will be achieved with a solution of 1% lidocaine without epinephrine and 0.5% bupivacaine without epinephrine (mixed in a 1:1 volume ratio) dosed once. A second dose will be given only in the case of complete block failure. |
| Control Arm | No intervention | –This group will receive the standard of care in our emergency department, as determined by their primary team. If a patient here receives a nerve block from the primary team, they will be handled with intention-to-treat analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with moderate to severe hand blast injury or other significantly painful hand or distal forearm injury Also, patients who...
- Are awake and alert
- Are able to endorse or rate their pain
- Require intravenous pain medication for their hand injury
- Are determined to be clinically sober for consent. They will need to be fluent of speech and able to articulate understanding of the procedure they will undergo and the study they will enter.
Key exclusion criteria (15 listed)
- Patient's who...
- Require surgical management, within one half hour, for any injury
- Require any emergent care, including resuscitation, the should preclude their regional pain management
- Are hemodynamically unstable
- Have signs of coagulopathy
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 |
|---|---|---|
| Ultrasound-guided forearm nerve blockAlso: Nerve blockAn ultrasound machine will be used to identify the median, radial, and ulnar nerves in the forearm, so that a needle may be used to apply lidocaine into the soft tissue space around those nerves. | Procedure or surgery | Nerve Block Arm |
| 1:1 volume measured solution of: 1% lidocaine without epinephrine and 0.5% bupivacaine without epinephrineThis is the anesthetic solution that will be administered during the ultrasound-guided nerve block | Drug | Nerve Block Arm |
| Bedside ultrasound machineThis is the device that will be used to visualize tissues during the ultrasound-guided nerve block. | Device | Nerve Block Arm |
Primary outcome
Pain Score (1-100 visual or verbal scale)
Time frame: 3 hour
Pain score (1-100 visual or verbal scale) at 3 hours post-block
3 secondary outcomes
Complications
Time frame: 4 weeks
Opioid medication use
Time frame: 1 day
Additional pain scores (1-100 visual or verbal scale)
Time frame: 0 - 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Background: PubMed 11561245Chung KC, Spilson SV. The frequency and epidemiology of hand and forearm fractures in the United States. J Hand Surg Am. 2001 Sep;26(5):908-15. doi: 10.1053/jhsu.2001.26322.
- Background: PubMed 20978218Patanwala AE, Keim SM, Erstad BL. Intravenous opioids for severe acute pain in the emergency department. Ann Pharmacother. 2010 Nov;44(11):1800-9. doi: 10.1345/aph.1P438. Epub 2010 Oct 26.
- Background: PubMed 14570678Williams SR, Chouinard P, Arcand G, Harris P, Ruel M, Boudreault D, Girard F. Ultrasound guidance speeds execution and improves the quality of supraclavicular block. Anesth Analg. 2003 Nov;97(5):1518-1523. doi: 10.1213/01.ANE.0000086730.09173.CA.
- Background: PubMed 15277302Marhofer P, Greher M, Kapral S. Ultrasound guidance in regional anaesthesia. Br J Anaesth. 2005 Jan;94(1):7-17. doi: 10.1093/bja/aei002. Epub 2004 Jul 26.
- Background: PubMed 4983335Witwicki T, Dziak A. [Sarcomatous degeneration in the course of Recklinghausen's neurofibromatosis]. Chir Narzadow Ruchu Ortop Pol. 1969;34(6):809-11. No abstract available. Polish.
- Background: PubMed 17499669Stone MB, Price DD, Wang R. Ultrasound-guided supraclavicular block for the treatment of upper extremity fractures, dislocations, and abscesses in the ED. Am J Emerg Med. 2007 May;25(4):472-5. doi: 10.1016/j.ajem.2006.08.019.
- Background: PubMed 27461885Wroe P, O'Shea R, Johnson B, Hoffman R, Nagdev A. Ultrasound-guided forearm nerve blocks for hand blast injuries: case series and multidisciplinary protocol. Am J Emerg Med. 2016 Sep;34(9):1895-7. doi: 10.1016/j.ajem.2016.06.111. Epub 2016 Jul 11. No abstract available.
- Background: PubMed 25803747Frenkel O, Liebmann O, Fischer JW. Ultrasound-guided forearm nerve blocks in kids: a novel method for pain control in the treatment of hand-injured pediatric patients in the emergency department. Pediatr Emerg Care. 2015 Apr;31(4):255-9. doi: 10.1097/PEC.0000000000000398.
- Background: PubMed 17052557Liebmann O, Price D, Mills C, Gardner R, Wang R, Wilson S, Gray A. Feasibility of forearm ultrasonography-guided nerve blocks of the radial, ulnar, and median nerves for hand procedures in the emergency department. Ann Emerg Med. 2006 Nov;48(5):558-62. doi: 10.1016/j.annemergmed.2006.04.014. Epub 2006 Jun 14.
- Background: PubMed 26931789Amini R, Kartchner JZ, Nagdev A, Adhikari S. Ultrasound-Guided Nerve Blocks in Emergency Medicine Practice. J Ultrasound Med. 2016 Apr;35(4):731-6. doi: 10.7863/ultra.15.05095. Epub 2016 Mar 1.
- 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.
Michael Vrablik, DO study director
University of Washington Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided forearm nerve block, 1:1 volume measured solution of: 1% lidocaine without epinephrine and 0.5% bupivacaine without epinephrine and Bedside ultrasound machine in people with Hand Injuries and Hand Injuries and Disorders, run by University of Washington 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 5 inclusion and 15 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 24 Oct 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain Score (1-100 visual or verbal scale) (time frame: 3 hour). 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 NCT03195413, which also lists 10 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 24 Oct 2018.