Rib FracturesEPERCNCT04482582
Early Percutaneous Cryoablation for Pain Control After Rib Fractures Among Elderly Patients
A study testing Cryoneurolysis in people with Rib Fractures, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to provide long-term pain control for elderly patients with rib fractures in order to minimize their risk of complications and return them to baseline functional capacity Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Rib Fractures
- What is being tested?
- Cryoneurolysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 30 Apr 2025
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients greater than 65 years with any acute rib fracture
- Pain score equal to or greater than 5 with deep inspiration.
- Presenting and admitted to Stanford Emergency Department
Who cannot join
- Radiographic evidence of metastasis to ribs
- Glasgow Coma Scale (GCS) score <13
- Patients undergoing SSRF
- Rib fractures located < 3cm from spinous process
- Coagulopathy (INR >1.5, Pat < 100)
- Other factors precluding cryoablation at IR attending's discretion
- If only ribs broken are 1,2 or 10,11, 12
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Hospital and Clinics
Palo Alto, California, 94305
About this study
The purpose of this study is to provide long-term pain control for elderly patients with rib fractures in order to minimize their risk of complications and return them to baseline functional capacity
Read the detailed description
The purpose of this study is to provide long-term pain control for elderly patients with rib fractures in order to minimize their risk of complications and return them to baseline functional capacity. In order to do this, we would offer a minimally invasive solution known as Cryoneurolysis. By directly applying cold Cryoneurolysis to the nerves, this can destroy nerve axons, resulting in Wallerian degeneration of the distal nerve without distorting epineural or perineurial tissue. The application of cryoneurolysis will help reduce the amount of narcotics the patient would need, and potentially lead to a better post-injury quality of life.
- Conditions
- Rib Fractures
- Being tested
- Cryoneurolysis, Standard of Care
- Keywords
- rib fractures, CT guided cryoneurolysis
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoneurolysisRadiation
Patients will be offered a minimally invasive solution known as cryoneurolysis. By directly applying a cold cryoneurolysis probe to the nerves the axon is destroyed, resulting in Wallerian degeneration of the distal nerve without distorting epineurial or perineurial tissue. Application of cryoneurolysis will help reduce the amount of narcotics the patient would need to take and instead provide them longer term pain control with minimal risk.
Standard of CareOther
Patients will be provided regular standard of care at the Stanford Hospital with long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury.
| Study group | Role | What they receive |
|---|---|---|
| Image-guided percutaneous ICN (pICN): Group A | Experimental | Patients who were admitted after a traumatic injury, with rib fractures identified, who are >= 65 years of age will be randomized to percutaneous image-guided cryoneurolysis (pICN) group within 72 hours of presentation. Receives: Radiation: Cryoneurolysis |
| Standard-of Care : Group B | Active comparator | Patients who were admitted after a traumatic injury, with rib fractures identified, who are >= 65 years of age will be randomized to standard-of-care group within 72 hours of presentation. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Pain Assessed by Numeric Pain Score
The patient will be asked to verbalize their numeric pain score on the day of hospital discharge. Pain is measured on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain.
Note: The timing of hospital discharge varies by patient as these are polytrauma patients.
Measured: Hospital discharge (up to 1 month)
Secondary outcomes (8)
30-day Mortality
Will be obtained from chart review after discharge
Measured: 1 month after hospital discharge
Number of Participants Requiring ICU Admission
Will be obtained from chart review after discharge
Measured: 1 month after hospital discharge
Length of Hospital Stay
The Length of Stay will be obtained from the patient's chart after discharge and will depend on the level of care required for recovery from their injuries.
Measured: Up to 1 month
Use of Narcotic Equivalents
Daily oral narcotic equivalents
Measured: Hospital discharge (up to 1 month), 1 month, 3 months, 12 months after hospital discharge
Number of Participants With a Rib-specific Readmission Within 30 Days of Discharge
The patient will be admitted back to the hospital if pain level relates to rib-specific injuries such as hemothorax and pneumonia.
Measured: 1 month after hospital discharge
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score
The McGill Pain Questionnaire (MPQ) is a validated 20 question instrument to quantify subjective pain and the scoring system yields a Pain Rating Index (PRI) score between Mild, Moderate or Severe. The questionnaire will be administered to the patient by study/ clinical staff at 1-month, 3-month, and 12-month follow-ups. Using the questionnaires, McGill Present Pain Intensity (PPI), Sensory, Affective, and Visual Analogue Scale scores will be calculated and reported. PPI and Visual Analogue Scale scores are on a scale of 0-10, Sensory scores are on a scale of 0-33, and Affective scores are on a scale of 0-12. Higher scores indicate worse pain for all McGill scores.
Measured: 1 month, 3 months, 12 months (all from hospital discharge)
The Glasgow Outcome Scale Extended (GOS-E) Score
The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates patient status into one of five categories: Dead, Vegetative State, Severe Disability, Moderate Disability or Good Recovery. The Extended GOS (GOSE) provides more detailed categorization into eight categories by subdividing the categories of severe disability, moderate disability and good recovery into a lower and upper category:
- Death (D)
- Vegetative state (VS)
- Lower severe disability (SD -)
- Upper severe disability (SD +)
- Lower moderate disability ( MD -)
- Upper moderate disability ( MD +)
- Lower good recovery (GR -)
- Upper good recovery (GR +)
The questionnaire will be administered to the patient by study/clinical staff upon discharge.
Measured: 1 month, 3 months, 12 months (all from hospital discharge)
Short Form (SF-12) Health Survey Scale Score
The 12-Item Short-Form Health Survey is a widely used composite score used to gauge overall health. The composite score is based on 8 domains scores contained in the SF-12 questionnaire, which will be administered to the patient by study/clinical staff upon discharge. The composite score is split into two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Both scores are on a scale of 0-100, with higher scores representing better mental health-related (MCS) or physical health-related (PCS) quality of life. The means of both scores are standardized to 50 with a standard devation of 10.
Measured: 1 month, 3 months, 12 months (all from hospital discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start1 Jun 2021
- Primary completion25 Apr 2024
- Study completion30 Apr 2025
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 (38)Papers the sponsor has linked to this study.
- Other trials for Rib FracturesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Model description
- We are proposing a prospective, randomized trial evaluating efficacy of image-guided percutaneous intercostal cryoneurolysis (pICN) for pain control after traumatic rib fractures in persons \>=65 years. Eligible patients would be enrolled by the trauma service after consent or assent is obtained. Patients will be randomized to either pICN within 72 hours of presentation or existing standard-of-care.
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Forrester, Stanford University
- Investigators
- Joseph D Forrester, MD, Principal investigator, Stanford UniversityNishita Kothary, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482582
- Sponsor's protocol ID
- 57099
- Acronym
- EPERC
- Status last verified
- Aug 2025
- First submitted
- 18 Jul 2020
- Last updated
- 27 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ziegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma. 1994 Dec;37(6):975-9. doi: 10.1097/00005373-199412000-00018.
PubMed 7996614Flagel BT, Luchette FA, Reed RL, Esposito TJ, Davis KA, Santaniello JM, Gamelli RL. Half-a-dozen ribs: the breakpoint for mortality. Surgery. 2005 Oct;138(4):717-23; discussion 723-5. doi: 10.1016/j.surg.2005.07.022.
PubMed 16269301Sharma OP, Oswanski MF, Jolly S, Lauer SK, Dressel R, Stombaugh HA. Perils of rib fractures. Am Surg. 2008 Apr;74(4):310-4. doi: 10.1177/000313480807400406.
PubMed 18453294Marasco S, Lee G, Summerhayes R, Fitzgerald M, Bailey M. Quality of life after major trauma with multiple rib fractures. Injury. 2015 Jan;46(1):61-5. doi: 10.1016/j.injury.2014.06.014. Epub 2014 Jun 21.
PubMed 25069400Fabricant L, Ham B, Mullins R, Mayberry J. Prolonged pain and disability are common after rib fractures. Am J Surg. 2013 May;205(5):511-5; discusssion 515-6. doi: 10.1016/j.amjsurg.2012.12.007.
PubMed 23592156Gordy S, Fabricant L, Ham B, Mullins R, Mayberry J. The contribution of rib fractures to chronic pain and disability. Am J Surg. 2014 May;207(5):659-62; discussion 662-3. doi: 10.1016/j.amjsurg.2013.12.012. Epub 2014 Jan 31.
PubMed 24612969Holcomb JB, McMullin NR, Kozar RA, Lygas MH, Moore FA. Morbidity from rib fractures increases after age 45. J Am Coll Surg. 2003 Apr;196(4):549-55. doi: 10.1016/S1072-7515(02)01894-X.
PubMed 12691929Stawicki SP, Grossman MD, Hoey BA, Miller DL, Reed JF 3rd. Rib fractures in the elderly: a marker of injury severity. J Am Geriatr Soc. 2004 May;52(5):805-8. doi: 10.1111/j.1532-5415.2004.52223.x.
PubMed 15086666Bulger EM, Arneson MA, Mock CN, Jurkovich GJ. Rib fractures in the elderly. J Trauma. 2000 Jun;48(6):1040-6; discussion 1046-7. doi: 10.1097/00005373-200006000-00007.
PubMed 10866248Liman ST, Kuzucu A, Tastepe AI, Ulasan GN, Topcu S. Chest injury due to blunt trauma. Eur J Cardiothorac Surg. 2003 Mar;23(3):374-8. doi: 10.1016/s1010-7940(02)00813-8.
PubMed 12614809Van Vledder MG, Kwakernaak V, Hagenaars T, Van Lieshout EMM, Verhofstad MHJ; South West Netherlands Trauma Region Study Group. Patterns of injury and outcomes in the elderly patient with rib fractures: a multicenter observational study. Eur J Trauma Emerg Surg. 2019 Aug;45(4):575-583. doi: 10.1007/s00068-018-0969-9. Epub 2018 Jun 15.
PubMed 29905897Witt CE, Bulger EM. Comprehensive approach to the management of the patient with multiple rib fractures: a review and introduction of a bundled rib fracture management protocol. Trauma Surg Acute Care Open. 2017 Jan 5;2(1):e000064. doi: 10.1136/tsaco-2016-000064. eCollection 2017.
PubMed 29766081Todd SR, McNally MM, Holcomb JB, Kozar RA, Kao LS, Gonzalez EA, Cocanour CS, Vercruysse GA, Lygas MH, Brasseaux BK, Moore FA. A multidisciplinary clinical pathway decreases rib fracture-associated infectious morbidity and mortality in high-risk trauma patients. Am J Surg. 2006 Dec;192(6):806-11. doi: 10.1016/j.amjsurg.2006.08.048.
PubMed 17161098de Jong MB, Kokke MC, Hietbrink F, Leenen LP. Surgical Management of Rib Fractures: Strategies and Literature Review. Scand J Surg. 2014 Jun;103(2):120-125. doi: 10.1177/1457496914531928. Epub 2014 Apr 29.
PubMed 24782038Shi HH, Esquivel M, Staudenmayer KL, Spain DA. Effects of mechanism of injury and patient age on outcomes in geriatric rib fracture patients. Trauma Surg Acute Care Open. 2017 Mar 16;2(1):e000074. doi: 10.1136/tsaco-2016-000074. eCollection 2017.
PubMed 29766084
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Percutaneous Cryoablation for Pain Control After Rib Fractures Among Elderly Patients
- ClinicalTrials.gov ID
- NCT04482582
- Acronym / sponsor ID
- EPERC / 57099
- Conditions
- Rib Fractures
- Keywords
- rib fractures, CT guided cryoneurolysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 22 Jul 2020 (actual)
- Results
- Posted 27 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to provide long-term pain control for elderly patients with rib fractures in order to minimize their risk of complications and return them to baseline functional capacity
Detailed description
The purpose of this study is to provide long-term pain control for elderly patients with rib fractures in order to minimize their risk of complications and return them to baseline functional capacity. In order to do this, we would offer a minimally invasive solution known as Cryoneurolysis. By directly applying cold Cryoneurolysis to the nerves, this can destroy nerve axons, resulting in Wallerian degeneration of the distal nerve without distorting epineural or perineurial tissue. The application of cryoneurolysis will help reduce the amount of narcotics the patient would need, and potentially lead to a better post-injury quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We are proposing a prospective, randomized trial evaluating efficacy of image-guided percutaneous intercostal cryoneurolysis (pICN) for pain control after traumatic rib fractures in persons >=65 years. Eligible patients would be enrolled by the trauma service after consent or assent is obtained. Patients will be randomized to either pICN within 72 hours of presentation or existing standard-of-care.
| Arm | Type | Receives |
|---|---|---|
| Image-guided percutaneous ICN (pICN): Group A | Experimental | Radiation: CryoneurolysisPatients who were admitted after a traumatic injury, with rib fractures identified, who are >= 65 years of age will be randomized to percutaneous image-guided cryoneurolysis (pICN) group within 72 hours of presentation. |
| Standard-of Care : Group B | Active comparator | Other: Standard of CarePatients who were admitted after a traumatic injury, with rib fractures identified, who are >= 65 years of age will be randomized to standard-of-care group within 72 hours of presentation. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients greater than 65 years with any acute rib fracture
- Pain score equal to or greater than 5 with deep inspiration.
- Presenting and admitted to Stanford Emergency Department
Key exclusion criteria (7 listed)
- Radiographic evidence of metastasis to ribs
- Glasgow Coma Scale (GCS) score <13
- Patients undergoing SSRF
- Rib fractures located < 3cm from spinous process
- Coagulopathy (INR >1.5, Pat < 100)
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 |
|---|---|---|
| CryoneurolysisPatients will be offered a minimally invasive solution known as cryoneurolysis. By directly applying a cold cryoneurolysis probe to the nerves the axon is destroyed, resulting in Wallerian degeneration of the distal nerve without distorting epineurial or perineurial tissue. Application of cryoneurolysis will help reduce the amount of narcotics the patient would need to take and instead provide them longer term pain control with minimal risk. | Radiation | Image-guided percutaneous ICN (pICN): Group A |
| Standard of CarePatients will be provided regular standard of care at the Stanford Hospital with long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury. | Other | Standard-of Care : Group B |
Primary outcome
Acute Pain Assessed by Numeric Pain Score
Time frame: Hospital discharge (up to 1 month)
The patient will be asked to verbalize their numeric pain score on the day of hospital discharge. Pain is measured on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain. Note: The timing of hospital discharge varies by patient as these are polytrauma patients.
8 secondary outcomes
30-day Mortality
Time frame: 1 month after hospital discharge
Number of Participants Requiring ICU Admission
Time frame: 1 month after hospital discharge
Length of Hospital Stay
Time frame: Up to 1 month
Use of Narcotic Equivalents
Time frame: Hospital discharge (up to 1 month), 1 month, 3 months, 12 months after hospital discharge
Number of Participants With a Rib-specific Readmission Within 30 Days of Discharge
Time frame: 1 month after hospital discharge
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score
Time frame: 1 month, 3 months, 12 months (all from hospital discharge)
The Glasgow Outcome Scale Extended (GOS-E) Score
Time frame: 1 month, 3 months, 12 months (all from hospital discharge)
Short Form (SF-12) Health Survey Scale Score
Time frame: 1 month, 3 months, 12 months (all from hospital discharge)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7996614Ziegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma. 1994 Dec;37(6):975-9. doi: 10.1097/00005373-199412000-00018.
- Background: PubMed 16269301Flagel BT, Luchette FA, Reed RL, Esposito TJ, Davis KA, Santaniello JM, Gamelli RL. Half-a-dozen ribs: the breakpoint for mortality. Surgery. 2005 Oct;138(4):717-23; discussion 723-5. doi: 10.1016/j.surg.2005.07.022.
- Background: PubMed 18453294Sharma OP, Oswanski MF, Jolly S, Lauer SK, Dressel R, Stombaugh HA. Perils of rib fractures. Am Surg. 2008 Apr;74(4):310-4. doi: 10.1177/000313480807400406.
- Background: PubMed 25069400Marasco S, Lee G, Summerhayes R, Fitzgerald M, Bailey M. Quality of life after major trauma with multiple rib fractures. Injury. 2015 Jan;46(1):61-5. doi: 10.1016/j.injury.2014.06.014. Epub 2014 Jun 21.
- Background: PubMed 23592156Fabricant L, Ham B, Mullins R, Mayberry J. Prolonged pain and disability are common after rib fractures. Am J Surg. 2013 May;205(5):511-5; discusssion 515-6. doi: 10.1016/j.amjsurg.2012.12.007.
- Background: PubMed 24612969Gordy S, Fabricant L, Ham B, Mullins R, Mayberry J. The contribution of rib fractures to chronic pain and disability. Am J Surg. 2014 May;207(5):659-62; discussion 662-3. doi: 10.1016/j.amjsurg.2013.12.012. Epub 2014 Jan 31.
- Background: PubMed 12691929Holcomb JB, McMullin NR, Kozar RA, Lygas MH, Moore FA. Morbidity from rib fractures increases after age 45. J Am Coll Surg. 2003 Apr;196(4):549-55. doi: 10.1016/S1072-7515(02)01894-X.
- Background: PubMed 15086666Stawicki SP, Grossman MD, Hoey BA, Miller DL, Reed JF 3rd. Rib fractures in the elderly: a marker of injury severity. J Am Geriatr Soc. 2004 May;52(5):805-8. doi: 10.1111/j.1532-5415.2004.52223.x.
- Background: PubMed 10866248Bulger EM, Arneson MA, Mock CN, Jurkovich GJ. Rib fractures in the elderly. J Trauma. 2000 Jun;48(6):1040-6; discussion 1046-7. doi: 10.1097/00005373-200006000-00007.
- Background: PubMed 12614809Liman ST, Kuzucu A, Tastepe AI, Ulasan GN, Topcu S. Chest injury due to blunt trauma. Eur J Cardiothorac Surg. 2003 Mar;23(3):374-8. doi: 10.1016/s1010-7940(02)00813-8.
- Background: PubMed 29905897Van Vledder MG, Kwakernaak V, Hagenaars T, Van Lieshout EMM, Verhofstad MHJ; South West Netherlands Trauma Region Study Group. Patterns of injury and outcomes in the elderly patient with rib fractures: a multicenter observational study. Eur J Trauma Emerg Surg. 2019 Aug;45(4):575-583. doi: 10.1007/s00068-018-0969-9. Epub 2018 Jun 15.
- Background: PubMed 29766081Witt CE, Bulger EM. Comprehensive approach to the management of the patient with multiple rib fractures: a review and introduction of a bundled rib fracture management protocol. Trauma Surg Acute Care Open. 2017 Jan 5;2(1):e000064. doi: 10.1136/tsaco-2016-000064. eCollection 2017.
- Individual participant dataSharing planned: No
Related trials for Rib Fractures
RecruitingPhase 4
INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures
Rib Fractures
Recruiting
Erector Spinae Plane vs Serratus Anterior Plane Catheter Infusions for Acute Pain Management in Patients With Traumatic Rib Fractures
Traumatic Rib Fracture(s), Traumatic Rib Fracture
Active, not recruiting
Effectiveness of an Innovative Chest Stabilizer in Rib Fracture Treatment: Impact on Respiratory Function, Complications, and Clinical Outcomes
Rib Fractures, Blunt Chest Trauma
Not yet recruitingPhase 2/3
Comparison of Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Erector Spinae Plane Block for Acute Pain Management in Patients With Traumatic Rib Fractures
Rib Fractures, Acute Pain
RecruitingObservational study
GNRI and PNI for Predicting Short-Term Outcomes in Older Adults With Multiple Rib Fractures
Multiple Rib Fractures, Isolated Blunt Thoracic Trauma
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.
Joseph D Forrester, MD principal investigator
Stanford University
Nishita Kothary, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoneurolysis in people with Rib Fractures, run by Stanford 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 7 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 27 Mar 2026. 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?
Yes. Results are posted in the registry (first posted 27 Mar 2026). 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?
Acute Pain Assessed by Numeric Pain Score (time frame: Hospital discharge (up to 1 month)). 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 NCT04482582, which also lists 38 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 27 Mar 2026.