Thoracic InjuriesCOPENCT03919916
Serratus Plane Block With Parenteral Opioid Analgesia Versus Patient Controlled Analgesia in Rib Fractures
A study testing Serratus plane block in people with Thoracic Injuries and Rib Fractures, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
In this multicentre randomised controlled trial, adult patients with isolated chest trauma and two or more unilateral rib fractures will be randomised to either serratus plane block and patient controlled analgesia or patient controlled analgesia alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Injuries, Rib Fractures, Anaesthesia, Local
- What is being tested?
- Serratus plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 May 2021to 10 Jun 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 of age or older
- Isolated chest trauma
- Two or more unilateral rib fractures
Who cannot join
- One unilateral rib fracture
- Bilateral rib fractures
- Flail chest
- Clavicular fractures
- Polytrauma
- Sternal fracture or injury
Show all 24Show fewer
- Thoracic spine injury
- GCS less than 15
- Acute or chronic confusional state
- Delirium or psychiatric illness
- Chronic lung disease necessitating home nebulisers and/or oxygen
- Coagulopathy, defined as a platelet count less than 100 x 109/l , PT >15 or APTT >38
- End stage liver disease
- Severe congestive cardiac failure
- Significant renal failure, defined as a creatinine >150µmol/l
- Local infection at potential site of SBP insertion
- Pregnancy or breastfeeding
- History of chronic pain or opioid dependence
- Current chronic analgesic therapy, not to include paracetamol, NSAIDs and/or codeine
- Requirement for tracheal intubation and mechanical ventilation
- Allergy to local anaesthetics and/or opioids
- Inability to control and self-administer opioids with PCA due to confusion, learning difficulties or poor manual dexterity
- Unable to speak and/or understand English
- Patients known to clinicians to be COVID-19 positive as determined by PCR or for whom there is a clinical suspicion that they might be COVID-19 positive will be excluded from the trial.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Chelsea and Westminster Hospital, Chelsea and Westminster Hospital NHS Foundation Trust
London, SW10 9NH
Research Delivery Operations Manager, 020 3315 6825, chelwest.research@nhs.net
Robert Pilling, MB ChB FRCA, robert.pilling1@nhs.net
About this study
Official title: Comparison of Serratus Plane Block With Parenteral Opioid Analgesia Versus Patient Controlled Analgesia Alone in Acute Rib fracturEs
In this multicentre randomised controlled trial, adult patients with isolated chest trauma and two or more unilateral rib fractures will be randomised to either serratus plane block and patient controlled analgesia or patient controlled analgesia alone. Our primary outcome is the static visual analogue scale score at one hour.
Read the detailed description
Rib breaks, or fractures, can cause pain that can be very difficult to manage and can result in chest infection and death. Such pain can be managed with either systemic drugs like morphine, which are given by mouth or through the veins, or local anaesthetic techniques, which can numb the painful area. Use of systemic drugs is however limited by significant side effects and traditional local anaesthetic techniques have problems of their own. Epidural analgesia, where local anaesthetic is placed near the spine, can only be done by those with a high level of technical skill and cannot be performed in patients with spine injuries, positioning difficulties and clotting problems. Complications and side effects can be common and/or serious and include failure, fall in blood pressure, and nerve and spinal cord damage. More recently, there has been interest in a new local anaesthetic technique, serratus plane block. Serratus plane block is simple to learn and can be done without any need for repositioning of the patient. It avoids some of the complications and side effects related to other local anaesthetic techniques and is more easily looked after by nursing staff on the ward. In view of this, we are aiming to recruit 44 adults with isolated chest injury and two or more rib fractures on one side. Each patient will either receive a serratus plane block in conjunction with morphine through the veins or just morphine alone. Our main aim is to assess how bad the pain is at 1 hour, but we will also compare the pain score, morphine consumption, lung function, level of sleepiness, and the frequency of low blood pressure, nausea and vomiting and slow breathing over the first 72 hours, as well as the hospital length of stay and occurrence of lung infection within 30 days.
- Conditions
- Thoracic Injuries, Rib Fractures, Anaesthesia, Local, Levobupivacaine, Analgesia, Patient-Controlled, Pain
- Being tested
- Serratus plane block, Patient controlled analgesia
- Medical subject headings
- Thoracic Injuries, Rib Fractures, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus plane blockProcedure or surgery
Also called Experimental
Placement of initial local anaesthetic bolus and catheter for continuous infusion in the plane between latissimus dorsi and serratus anterior in the midaxillary line at the level of the 5th rib
Patient controlled analgesiaOther
Also called Active comparator
Computerised pump device facilitating the patient self administration and titration as needed of morphine
| Study group | Role | What they receive |
|---|---|---|
| Serratus plane block and patient controlled analgesia | Experimental | Initial local anaesthetic bolus of 0.4 ml/kg of 0.25% levobupivacaine. Subsequent continuous local anaesthetic infusion of 0.125% levobupivacaine
Patient controlled analgesia programmed with morphine to deliver on demand boluses of 1 mg and limited by a lockout time of 5 minutes Receives: Procedure: Serratus plane block; Other: Patient controlled analgesia |
| Patient controlled analgesia only | Active comparator | Patient controlled analgesia programmed with morphine to deliver on demand boluses of 1 mg and limited by a lockout time of 5 minutes Receives: Other: Patient controlled analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static visual analogue score (0-10) at 1 hour
Defined as pain score at rest
Measured: Measured at 1 hour
Secondary outcomes (10)
Dynamic visual analogue score (0-10)
Defined as pain score on deep inspiration
Measured: Measured at 1 hour, 24, 48 and 72 hours
Static visual analogue score (0-10)
Defined as pain score at rest
Measured: Measured at 24, 48 and 72 hours
Morphine consumption
Amount of intravenous morphine consumed within each 24 hour period
Measured: Measured at 24, 48 and 72 hours
Peak expiratory flow rate
Calculated as a percentage of predicted
Measured: Measured at 1, 24, 48 and 72 hours
Level of sedation
Assessed using the Ramsay Sedation Scale (1-6) and a value of 2 is considered the best outcome
Measured: Measured at 24, 48 and 72 hours
Incidence of hypotension
Defined as a systolic blood pressure less than 90 mmHg
Measured: Measured at 24, 48 and 72 hours
Incidence of nausea and vomiting
Assessed using the Nausea-Vomiting Scale (1-4) and lower values are considered a better outcome
Measured: Measured at 24, 48 and 72 hours
Incidence of respiratory depression
Defined as a respiratory rate of less than 12 breaths per minute
Measured: Measured at 24, 48 and 72 hours
Occurence of pneumonia
Defined as occurence of in-hospital pneumonia from admission to discharge of this hospitalisation.
Measured: Within 30 days
Hospital length of stay
Defined as the number of days the patient stayed in hospital
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start28 May 2021
- Primary completion10 May 2022 (estimated)
- Study completion10 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Thoracic InjuriesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- St George's University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Damon Foster, Study chair, Chelsea and Westminster NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919916
- Sponsor's protocol ID
- C&W19/007
- Acronym
- COPE
- Status last verified
- May 2021
- First submitted
- 8 Apr 2019
- Last updated
- 2 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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 16269301Sirmali M, Turut H, Topcu S, Gulhan E, Yazici U, Kaya S, Tastepe I. A comprehensive analysis of traumatic rib fractures: morbidity, mortality and management. Eur J Cardiothorac Surg. 2003 Jul;24(1):133-8. doi: 10.1016/s1010-7940(03)00256-2.
PubMed 12853057Bulger 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 10866248Fabricant 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 24612969Stawicki 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 15086666Battle CE, Hutchings H, Evans PA. Risk factors that predict mortality in patients with blunt chest wall trauma: a systematic review and meta-analysis. Injury. 2012 Jan;43(1):8-17. doi: 10.1016/j.injury.2011.01.004. Epub 2011 Jan 22.
PubMed 21256488Liman 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 12614809Clark GC, Schecter WP, Trunkey DD. Variables affecting outcome in blunt chest trauma: flail chest vs. pulmonary contusion. J Trauma. 1988 Mar;28(3):298-304. doi: 10.1097/00005373-198803000-00004.
PubMed 3351988Dehghan N, de Mestral C, McKee MD, Schemitsch EH, Nathens A. Flail chest injuries: a review of outcomes and treatment practices from the National Trauma Data Bank. J Trauma Acute Care Surg. 2014 Feb;76(2):462-8. doi: 10.1097/TA.0000000000000086.
PubMed 24458051Galvagno SM Jr, Smith CE, Varon AJ, Hasenboehler EA, Sultan S, Shaefer G, To KB, Fox AD, Alley DE, Ditillo M, Joseph BA, Robinson BR, Haut ER. Pain management for blunt thoracic trauma: A joint practice management guideline from the Eastern Association for the Surgery of Trauma and Trauma Anesthesiology Society. J Trauma Acute Care Surg. 2016 Nov;81(5):936-951. doi: 10.1097/TA.0000000000001209.
PubMed 27533913Bayouth L, Safcsak K, Cheatham ML, Smith CP, Birrer KL, Promes JT. Early intravenous ibuprofen decreases narcotic requirement and length of stay after traumatic rib fracture. Am Surg. 2013 Nov;79(11):1207-12.
PubMed 24165259Yang Y, Young JB, Schermer CR, Utter GH. Use of ketorolac is associated with decreased pneumonia following rib fractures. Am J Surg. 2014 Apr;207(4):566-72. doi: 10.1016/j.amjsurg.2013.05.011. Epub 2013 Oct 7.
PubMed 24112670Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.
PubMed 18443635
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Serratus Plane Block With Parenteral Opioid Analgesia Versus Patient Controlled Analgesia Alone in Acute Rib fracturEs
- ClinicalTrials.gov ID
- NCT03919916
- Acronym / sponsor ID
- COPE / C&W19/007
- Conditions
- Thoracic Injuries, Rib Fractures, Anaesthesia, Local, Levobupivacaine, Analgesia, Patient-Controlled, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Collaborators
- St George's University Hospitals NHS Foundation Trust
- Study start
- 28 May 2021 (actual)
- Primary completion
- 10 May 2022 (estimated)
- Study completion
- 10 Jun 2022 (estimated)
- First posted
- 18 Apr 2019 (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.
In this multicentre randomised controlled trial, adult patients with isolated chest trauma and two or more unilateral rib fractures will be randomised to either serratus plane block and patient controlled analgesia or patient controlled analgesia alone. Our primary outcome is the static visual analogue scale score at one hour.
Detailed description
Rib breaks, or fractures, can cause pain that can be very difficult to manage and can result in chest infection and death. Such pain can be managed with either systemic drugs like morphine, which are given by mouth or through the veins, or local anaesthetic techniques, which can numb the painful area. Use of systemic drugs is however limited by significant side effects and traditional local anaesthetic techniques have problems of their own. Epidural analgesia, where local anaesthetic is placed near the spine, can only be done by those with a high level of technical skill and cannot be performed in patients with spine injuries, positioning difficulties and clotting problems. Complications and side effects can be common and/or serious and include failure, fall in blood pressure, and nerve and spinal cord damage. More recently, there has been interest in a new local anaesthetic technique, serratus plane block. Serratus plane block is simple to learn and can be done without any need for repositioning of the patient. It avoids some of the complications and side effects related to other local anaesthetic techniques and is more easily looked after by nursing staff on the ward. In view of this, we are aiming to recruit 44 adults with isolated chest injury and two or more rib fractures on one side. Each patient will either receive a serratus plane block in conjunction with morphine through the veins or just morphine alone. Our main aim is to assess how bad the pain is at 1 hour, but we will also compare the pain score, morphine consumption, lung function, level of sleepiness, and the frequency of low blood pressure, nausea and vomiting and slow breathing over the first 72 hours, as well as the hospital length of stay and occurrence of lung infection within 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus plane block and patient controlled analgesia | Experimental | Procedure: Serratus plane block, Other: Patient controlled analgesiaInitial local anaesthetic bolus of 0.4 ml/kg of 0.25% levobupivacaine. Subsequent continuous local anaesthetic infusion of 0.125% levobupivacaine Patient controlled analgesia programmed with morphine to deliver on demand boluses of 1 mg and limited by a lockout time of 5 minutes |
| Patient controlled analgesia only | Active comparator | Other: Patient controlled analgesiaPatient controlled analgesia programmed with morphine to deliver on demand boluses of 1 mg and limited by a lockout time of 5 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Isolated chest trauma
- Two or more unilateral rib fractures
Key exclusion criteria (24 listed)
- One unilateral rib fracture
- Bilateral rib fractures
- Flail chest
- Clavicular fractures
- Polytrauma
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 |
|---|---|---|
| Serratus plane blockAlso: ExperimentalPlacement of initial local anaesthetic bolus and catheter for continuous infusion in the plane between latissimus dorsi and serratus anterior in the midaxillary line at the level of the 5th rib | Procedure or surgery | Serratus plane block and patient controlled analgesia |
| Patient controlled analgesiaAlso: Active comparatorComputerised pump device facilitating the patient self administration and titration as needed of morphine | Other | Patient controlled analgesia only, Serratus plane block and patient controlled analgesia |
Primary outcome
Static visual analogue score (0-10) at 1 hour
Time frame: Measured at 1 hour
Defined as pain score at rest
10 secondary outcomes
Dynamic visual analogue score (0-10)
Time frame: Measured at 1 hour, 24, 48 and 72 hours
Static visual analogue score (0-10)
Time frame: Measured at 24, 48 and 72 hours
Morphine consumption
Time frame: Measured at 24, 48 and 72 hours
Peak expiratory flow rate
Time frame: Measured at 1, 24, 48 and 72 hours
Level of sedation
Time frame: Measured at 24, 48 and 72 hours
Incidence of hypotension
Time frame: Measured at 24, 48 and 72 hours
Incidence of nausea and vomiting
Time frame: Measured at 24, 48 and 72 hours
Incidence of respiratory depression
Time frame: Measured at 24, 48 and 72 hours
Occurence of pneumonia
Time frame: Within 30 days
Hospital length of stay
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- 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 12853057Sirmali M, Turut H, Topcu S, Gulhan E, Yazici U, Kaya S, Tastepe I. A comprehensive analysis of traumatic rib fractures: morbidity, mortality and management. Eur J Cardiothorac Surg. 2003 Jul;24(1):133-8. doi: 10.1016/s1010-7940(03)00256-2.
- 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 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 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 21256488Battle CE, Hutchings H, Evans PA. Risk factors that predict mortality in patients with blunt chest wall trauma: a systematic review and meta-analysis. Injury. 2012 Jan;43(1):8-17. doi: 10.1016/j.injury.2011.01.004. Epub 2011 Jan 22.
- 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 3351988Clark GC, Schecter WP, Trunkey DD. Variables affecting outcome in blunt chest trauma: flail chest vs. pulmonary contusion. J Trauma. 1988 Mar;28(3):298-304. doi: 10.1097/00005373-198803000-00004.
- Background: PubMed 24458051Dehghan N, de Mestral C, McKee MD, Schemitsch EH, Nathens A. Flail chest injuries: a review of outcomes and treatment practices from the National Trauma Data Bank. J Trauma Acute Care Surg. 2014 Feb;76(2):462-8. doi: 10.1097/TA.0000000000000086.
- Background: PubMed 27533913Galvagno SM Jr, Smith CE, Varon AJ, Hasenboehler EA, Sultan S, Shaefer G, To KB, Fox AD, Alley DE, Ditillo M, Joseph BA, Robinson BR, Haut ER. Pain management for blunt thoracic trauma: A joint practice management guideline from the Eastern Association for the Surgery of Trauma and Trauma Anesthesiology Society. J Trauma Acute Care Surg. 2016 Nov;81(5):936-951. doi: 10.1097/TA.0000000000001209.
- 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.
Damon Foster study chair
Chelsea and Westminster NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus plane block in people with Thoracic Injuries and Rib Fractures, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
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 24 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: status not confirmed, as of the sponsor's last update on 2 Jun 2021. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert J Pilling, MB ChB FRCA (02033158000 ext. 58026, Robert.Pilling@chelwest.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static visual analogue score (0-10) at 1 hour (time frame: Measured at 1 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 NCT03919916, which also lists 35 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 2 Jun 2021.