Hip FracturesNCT04882384
Pericapsular Nerve Group Block for Hip Fractures
A study testing Pericapsular Nerve Group Block in people with Hip Fractures and Pain, Acute, run by Jacobi Medical Center at 1 site in United States.
Trial summary
This will be a feasibility study to see if it feasible to perform the Pericapsular Nerve Group Block for hip fractures in the Emergency Department. In addition, we will look at the efficacy of the block in these 10 patients by measuring pain scores at pre-determine time points for 16 hours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures, Pain, Acute
- What is being tested?
- Pericapsular Nerve Group Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 15 Mar 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years old (male or female)
- cognitive intact patients with Isolated hip fractures (both surgical and non-surgical candidates)
- displaced/non-displaced displaced/non-displaced sub-trochanteric
- displaced/non-displaced intra-trochanteric
- displaced/non-displaced femoral neck/head fractures
Who cannot join
- patient refusal
- allergy to local anesthetic
- overlying infection at injection site
- patients who cannot provide consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pericapsular Nerve Group Blocks for Hip Fractures in the Emergency Department: A Prospective, Observational, Feasibility Study
This will be a feasibility study to see if it feasible to perform the Pericapsular Nerve Group Block for hip fractures in the Emergency Department. In addition, we will look at the efficacy of the block in these 10 patients by measuring pain scores at pre-determine time points for 16 hours.
Read the detailed description
Isolated hip fractures are common and are associated with significant morbidity and mortality.1 2 The American Academy of Orthopedics provides strong evidence for peripheral nerve blocks as a safe, effective method to manage perioperative analgesia. Literature shows that peripheral nerve blocks decrease the need for opioids and its deleterious effects including respiratory depression and delirium, and can provide superior pain control when compared to parenteral analgesia.2-10 In addition to significant pain, patients with isolated hip fractures are at risk for underassessment of pain and subject to considerable delays in analgesic administration even after their pain is identified, in one study the average delay to treatment was 122 minutes.11
Ultrasound guidance has been shown to be a safe method for performing a peripheral nerve block.12 Overall, peripheral nerve blocks are a safe procedure with rare complications of nerve injury or local anesthetic toxicity.12,13
While the femoral nerve block, the "3-in-1" block, and the fascia iliaca block are popular analgesic approaches to hip fractures, they have their downsides. Literature suggests that these blocks provide inconsistent and partial analgesia.2,15, 16 A possible explanation is demonstrated by both MRI and cadaver studies that illustrate that the obturator nerve (sensory innervation) is rarely affected by these three blocks and can cause motor weakness. The potential benefit of a pericapsular nerve group (PENG) block is that its effect is sensory, while preserving motor function.
The target of the PENG block, the anterior zone of the hip, contains the highest relative concentration of sensory fibers to the hip. This part of the labrum is innervated by articular branches of the femoral nerve (FN), accessory obturator nerve (AON) and obturator nerve (ON).2 17-20 The PENG block is a novel approach described by Giron-Arango et al in 2018 as an ultrasound guided technique to target the FN, AON, and ON.2 By targeting the articular branches of these three nerves as they course between the anterior inferior iliac spine and the iliopubic eminence (IPE), the PENG block is able to provide a sensory-only blockade without causing motor weakness.2 21-23 Currently, there are case series/reports showing that the PENG block is highly efficacious for pain.
Aim/Objectives:
We intend to conduct a feasibility study among 10 emergency department (ED) patients with hip fractures to determine logistical barriers to introducing a new procedure in an ED as well as to assessing pain and efficacy of the PENG block.
Study Design:
This study will take place in the Jacobi Adult ED. This will be a 10-patient prospective, observational, feasibility study regarding the PENG block for hip fractures in adults. The emergency physician (EP) will identify 10 cognitively intact patients with hip fractures in the ED. The EP has the option to provide a standard dose of intravenous narcotics during the initial assessment if clinically warranted until radiographic confirmation of a fracture. Once a fracture has been confirmed, the research team will be contacted. The patient will be enrolled into the study if they had a pain score greater than or equal to 5/10 at triage or upon initial EP evaluation before the intravenous analgesia, if there was no pre-hospital analgesia given, and if there are no concomitant injuries. To be included into the study, the patient will be alert, oriented to person, place, and time, and must be able to demonstrate understanding of the written consent form. Patient also has to be able to indicate how much pain they are in using a visual analog pain scale, with 0 being no pain and 10 being severe pain, and be able to report any side effects experienced after administration of the nerve blockade. If the patient refuses to be in the study, it will not hinder the patient from obtaining other avenues of pain management and all other care. The pain score assessed just before the nerve block will be considered time 0. The blocks will be performed with dynamic sonographic guidance using a Sonosite X-porte machine and the curvilinear transducer using sterile technique. EP were trained on the PENG block after a workshop series consisting on a lecture and three hands- on training using a low-fidelity model. Competency was determined once the participant successfully performed the block on the low-fidelity model without intervention by the trainer. They also had to pass a three part check list, including taking consent and verbalizing aseptic technique, and scoring > 90% on a multiple choice quiz. Patients are eligible to receive standardized rescue doses of intravenous narcotics after the PENG block if they experience continued pain. Pain scores will be assessed for 16 hours at pre-determined points.
- Conditions
- Hip Fractures, Pain, Acute
- Being tested
- Pericapsular Nerve Group Block
- Medical subject headings
- Hip Fractures, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular Nerve Group BlockProcedure or surgery
This will be a peripheral nerve block.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral Nerve Block (PENG) | Experimental | Patients will receive the Pericapsular Nerve Group Block. Receives: Procedure: Pericapsular Nerve Group Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
Visual Analog Pain Scale (VAS) from 0-10 with higher scores indicating worsening pain
Measured: 16 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start1 Jul 2021
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Hip 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacobi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anirudh Ramachandran, Jacobi Medical Center
- Investigators
- Michael Halperin, Principal investigator, Jacobi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882384
- Sponsor's protocol ID
- 2021-12647
- Status last verified
- Mar 2022
- First submitted
- 8 May 2021
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brauer CA, Coca-Perraillon M, Cutler DM, Rosen AB. Incidence and mortality of hip fractures in the United States. JAMA. 2009 Oct 14;302(14):1573-9. doi: 10.1001/jama.2009.1462.
PubMed 19826027Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
PubMed 30063657Ma YH, Wu J, Jia B, Xue JX, Wang TL. [Continuous fascia iliaca compartment block combined with oral analgesics for pre-operative pain control in elderly hip fracture patients]. Zhonghua Yi Xue Za Zhi. 2018 Mar 13;98(10):723-727. doi: 10.3760/cma.j.issn.0376-2491.2018.10.002. Chinese.
PubMed 29562394Morrison RS, Dickman E, Hwang U, Akhtar S, Ferguson T, Huang J, Jeng CL, Nelson BP, Rosenblatt MA, Silverstein JH, Strayer RJ, Torrillo TM, Todd KH. Regional Nerve Blocks Improve Pain and Functional Outcomes in Hip Fracture: A Randomized Controlled Trial. J Am Geriatr Soc. 2016 Dec;64(12):2433-2439. doi: 10.1111/jgs.14386. Epub 2016 Oct 27.
PubMed 27787895Beaudoin FL, Nagdev A, Merchant RC, Becker BM. Ultrasound-guided femoral nerve blocks in elderly patients with hip fractures. Am J Emerg Med. 2010 Jan;28(1):76-81. doi: 10.1016/j.ajem.2008.09.015.
PubMed 20006206Beaudoin FL, Haran JP, Liebmann O. A comparison of ultrasound-guided three-in-one femoral nerve block versus parenteral opioids alone for analgesia in emergency department patients with hip fractures: a randomized controlled trial. Acad Emerg Med. 2013 Jun;20(6):584-91. doi: 10.1111/acem.12154.
PubMed 23758305Turner AL, Stevenson MD, Cross KP. Impact of ultrasound-guided femoral nerve blocks in the pediatric emergency department. Pediatr Emerg Care. 2014 Apr;30(4):227-9. doi: 10.1097/PEC.0000000000000101.
PubMed 24651214Haines L, Dickman E, Ayvazyan S, Pearl M, Wu S, Rosenblum D, Likourezos A. Ultrasound-guided fascia iliaca compartment block for hip fractures in the emergency department. J Emerg Med. 2012 Oct;43(4):692-7. doi: 10.1016/j.jemermed.2012.01.050. Epub 2012 Apr 9.
PubMed 22494596Guay J, Parker MJ, Griffiths R, Kopp S. Peripheral nerve blocks for hip fractures. Cochrane Database Syst Rev. 2017 May 11;5(5):CD001159. doi: 10.1002/14651858.CD001159.pub2.
PubMed 28494088Hwang U, Richardson LD, Sonuyi TO, Morrison RS. The effect of emergency department crowding on the management of pain in older adults with hip fracture. J Am Geriatr Soc. 2006 Feb;54(2):270-5. doi: 10.1111/j.1532-5415.2005.00587.x.
PubMed 16460378Orebaugh SL, Kentor ML, Williams BA. Adverse outcomes associated with nerve stimulator-guided and ultrasound-guided peripheral nerve blocks by supervised trainees: update of a single-site database. Reg Anesth Pain Med. 2012 Nov-Dec;37(6):577-82. doi: 10.1097/AAP.0b013e318263d396.
PubMed 22996199Barrington MJ, Watts SA, Gledhill SR, Thomas RD, Said SA, Snyder GL, Tay VS, Jamrozik K. Preliminary results of the Australasian Regional Anaesthesia Collaboration: a prospective audit of more than 7000 peripheral nerve and plexus blocks for neurologic and other complications. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):534-41. doi: 10.1097/aap.0b013e3181ae72e8.
PubMed 19916206Dochez E, van Geffen GJ, Bruhn J, Hoogerwerf N, van de Pas H, Scheffer G. Prehospital administered fascia iliaca compartment block by emergency medical service nurses, a feasibility study. Scand J Trauma Resusc Emerg Med. 2014 Jun 23;22:38. doi: 10.1186/1757-7241-22-38.
PubMed 24957807Swenson JD, Davis JJ, Stream JO, Crim JR, Burks RT, Greis PE. Local anesthetic injection deep to the fascia iliaca at the level of the inguinal ligament: the pattern of distribution and effects on the obturator nerve. J Clin Anesth. 2015 Dec;27(8):652-7. doi: 10.1016/j.jclinane.2015.07.001. Epub 2015 Aug 13.
PubMed 26277873Marhofer P, Nasel C, Sitzwohl C, Kapral S. Magnetic resonance imaging of the distribution of local anesthetic during the three-in-one block. Anesth Analg. 2000 Jan;90(1):119-24. doi: 10.1097/00000539-200001000-00027.
PubMed 10624991
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericapsular Nerve Group Blocks for Hip Fractures in the Emergency Department: A Prospective, Observational, Feasibility Study
- ClinicalTrials.gov ID
- NCT04882384
- Acronym / sponsor ID
- 2021-12647
- Conditions
- Hip Fractures, Pain, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Jacobi Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 12 May 2021 (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 will be a feasibility study to see if it feasible to perform the Pericapsular Nerve Group Block for hip fractures in the Emergency Department. In addition, we will look at the efficacy of the block in these 10 patients by measuring pain scores at pre-determine time points for 16 hours.
Detailed description
Isolated hip fractures are common and are associated with significant morbidity and mortality.1 2 The American Academy of Orthopedics provides strong evidence for peripheral nerve blocks as a safe, effective method to manage perioperative analgesia. Literature shows that peripheral nerve blocks decrease the need for opioids and its deleterious effects including respiratory depression and delirium, and can provide superior pain control when compared to parenteral analgesia.2-10 In addition to significant pain, patients with isolated hip fractures are at risk for underassessment of pain and subject to considerable delays in analgesic administration even after their pain is identified, in one study the average delay to treatment was 122 minutes.11
Ultrasound guidance has been shown to be a safe method for performing a peripheral nerve block.12 Overall, peripheral nerve blocks are a safe procedure with rare complications of nerve injury or local anesthetic toxicity.12,13
While the femoral nerve block, the "3-in-1" block, and the fascia iliaca block are popular analgesic approaches to hip fractures, they have their downsides. Literature suggests that these blocks provide inconsistent and partial analgesia.2,15, 16 A possible explanation is demonstrated by both MRI and cadaver studies that illustrate that the obturator nerve (sensory innervation) is rarely affected by these three blocks and can cause motor weakness. The potential benefit of a pericapsular nerve group (PENG) block is that its effect is sensory, while preserving motor function.
The target of the PENG block, the anterior zone of the hip, contains the highest relative concentration of sensory fibers to the hip. This part of the labrum is innervated by articular branches of the femoral nerve (FN), accessory obturator nerve (AON) and obturator nerve (ON).2 17-20 The PENG block is a novel approach described by Giron-Arango et al in 2018 as an ultrasound guided technique to target the FN, AON, and ON.2 By targeting the articular branches of these three nerves as they course between the anterior inferior iliac spine and the iliopubic eminence (IPE), the PENG block is able to provide a sensory-only blockade without causing motor weakness.2 21-23 Currently, there are case series/reports showing that the PENG block is highly efficacious for pain.
Aim/Objectives:
We intend to conduct a feasibility study among 10 emergency department (ED) patients with hip fractures to determine logistical barriers to introducing a new procedure in an ED as well as to assessing pain and efficacy of the PENG block.
Study Design:
This study will take place in the Jacobi Adult ED. This will be a 10-patient prospective, observational, feasibility study regarding the PENG block for hip fractures in adults. The emergency physician (EP) will identify 10 cognitively intact patients with hip fractures in the ED. The EP has the option to provide a standard dose of intravenous narcotics during the initial assessment if clinically warranted until radiographic confirmation of a fracture. Once a fracture has been confirmed, the research team will be contacted. The patient will be enrolled into the study if they had a pain score greater than or equal to 5/10 at triage or upon initial EP evaluation before the intravenous analgesia, if there was no pre-hospital analgesia given, and if there are no concomitant injuries. To be included into the study, the patient will be alert, oriented to person, place, and time, and must be able to demonstrate understanding of the written consent form. Patient also has to be able to indicate how much pain they are in using a visual analog pain scale, with 0 being no pain and 10 being severe pain, and be able to report any side effects experienced after administration of the nerve blockade. If the patient refuses to be in the study, it will not hinder the patient from obtaining other avenues of pain management and all other care. The pain score assessed just before the nerve block will be considered time 0. The blocks will be performed with dynamic sonographic guidance using a Sonosite X-porte machine and the curvilinear transducer using sterile technique. EP were trained on the PENG block after a workshop series consisting on a lecture and three hands- on training using a low-fidelity model. Competency was determined once the participant successfully performed the block on the low-fidelity model without intervention by the trainer. They also had to pass a three part check list, including taking consent and verbalizing aseptic technique, and scoring > 90% on a multiple choice quiz. Patients are eligible to receive standardized rescue doses of intravenous narcotics after the PENG block if they experience continued pain. Pain scores will be assessed for 16 hours at pre-determined points.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peripheral Nerve Block (PENG) | Experimental | Procedure: Pericapsular Nerve Group BlockPatients will receive the Pericapsular Nerve Group Block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18 years old (male or female)
- cognitive intact patients with Isolated hip fractures (both surgical and non-surgical candidates)
- displaced/non-displaced displaced/non-displaced sub-trochanteric
- displaced/non-displaced intra-trochanteric
- displaced/non-displaced femoral neck/head fractures
Key exclusion criteria (4 listed)
- patient refusal
- allergy to local anesthetic
- overlying infection at injection site
- patients who cannot provide consent.
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 |
|---|---|---|
| Pericapsular Nerve Group BlockThis will be a peripheral nerve block. | Procedure or surgery | Peripheral Nerve Block (PENG) |
Primary outcome
Pain Scores
Time frame: 16 hours.
Visual Analog Pain Scale (VAS) from 0-10 with higher scores indicating worsening pain
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 21 Mar 2022.
- Background: PubMed 19826027Brauer CA, Coca-Perraillon M, Cutler DM, Rosen AB. Incidence and mortality of hip fractures in the United States. JAMA. 2009 Oct 14;302(14):1573-9. doi: 10.1001/jama.2009.1462.
- Background: PubMed 30063657Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
- Background: PubMed 29562394Ma YH, Wu J, Jia B, Xue JX, Wang TL. [Continuous fascia iliaca compartment block combined with oral analgesics for pre-operative pain control in elderly hip fracture patients]. Zhonghua Yi Xue Za Zhi. 2018 Mar 13;98(10):723-727. doi: 10.3760/cma.j.issn.0376-2491.2018.10.002. Chinese.
- Background: PubMed 27787895Morrison RS, Dickman E, Hwang U, Akhtar S, Ferguson T, Huang J, Jeng CL, Nelson BP, Rosenblatt MA, Silverstein JH, Strayer RJ, Torrillo TM, Todd KH. Regional Nerve Blocks Improve Pain and Functional Outcomes in Hip Fracture: A Randomized Controlled Trial. J Am Geriatr Soc. 2016 Dec;64(12):2433-2439. doi: 10.1111/jgs.14386. Epub 2016 Oct 27.
- Background: PubMed 20006206Beaudoin FL, Nagdev A, Merchant RC, Becker BM. Ultrasound-guided femoral nerve blocks in elderly patients with hip fractures. Am J Emerg Med. 2010 Jan;28(1):76-81. doi: 10.1016/j.ajem.2008.09.015.
- Background: PubMed 23758305Beaudoin FL, Haran JP, Liebmann O. A comparison of ultrasound-guided three-in-one femoral nerve block versus parenteral opioids alone for analgesia in emergency department patients with hip fractures: a randomized controlled trial. Acad Emerg Med. 2013 Jun;20(6):584-91. doi: 10.1111/acem.12154.
- Background: PubMed 24651214Turner AL, Stevenson MD, Cross KP. Impact of ultrasound-guided femoral nerve blocks in the pediatric emergency department. Pediatr Emerg Care. 2014 Apr;30(4):227-9. doi: 10.1097/PEC.0000000000000101.
- Background: PubMed 22494596Haines L, Dickman E, Ayvazyan S, Pearl M, Wu S, Rosenblum D, Likourezos A. Ultrasound-guided fascia iliaca compartment block for hip fractures in the emergency department. J Emerg Med. 2012 Oct;43(4):692-7. doi: 10.1016/j.jemermed.2012.01.050. Epub 2012 Apr 9.
- Background: PubMed 28494088Guay J, Parker MJ, Griffiths R, Kopp S. Peripheral nerve blocks for hip fractures. Cochrane Database Syst Rev. 2017 May 11;5(5):CD001159. doi: 10.1002/14651858.CD001159.pub2.
- Background: PubMed 16460378Hwang U, Richardson LD, Sonuyi TO, Morrison RS. The effect of emergency department crowding on the management of pain in older adults with hip fracture. J Am Geriatr Soc. 2006 Feb;54(2):270-5. doi: 10.1111/j.1532-5415.2005.00587.x.
- Background: PubMed 22996199Orebaugh SL, Kentor ML, Williams BA. Adverse outcomes associated with nerve stimulator-guided and ultrasound-guided peripheral nerve blocks by supervised trainees: update of a single-site database. Reg Anesth Pain Med. 2012 Nov-Dec;37(6):577-82. doi: 10.1097/AAP.0b013e318263d396.
- Background: PubMed 19916206Barrington MJ, Watts SA, Gledhill SR, Thomas RD, Said SA, Snyder GL, Tay VS, Jamrozik K. Preliminary results of the Australasian Regional Anaesthesia Collaboration: a prospective audit of more than 7000 peripheral nerve and plexus blocks for neurologic and other complications. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):534-41. doi: 10.1097/aap.0b013e3181ae72e8.
- 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 Halperin principal investigator
Jacobi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pericapsular Nerve Group Block in people with Hip Fractures and Pain, Acute, run by Jacobi Medical Center 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 4 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 21 Mar 2022. 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 Scores (time frame: 16 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 NCT04882384, which also lists 22 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 21 Mar 2022.