Pain, PostoperativeNCT03496194
Anaesthesiological Involvement in Postoperative Pain Treatment
An observational study of Pain, Postoperative and Anesthesia, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
This study aims to investigate the current organization and management of postoperative pain in Denmark, especially for invasive pain treatment modalities (epidural infusions, PCA and regional blocks), in a national survey covering the activities in Danish Hospitals. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Anesthesia, Epidural Analgesia
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Apr 2018to 6 Jun 2018
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Chief physicians for the postoperative care unit (PACU) at all Danish Departments of Anaesthesia
Who may be able to join
- All departments of anesthesia with a PACU in Denmark
Who cannot join
- PACUs as part of day case surgery will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anaesthesiological Involvement in Postoperative Pain Treatment - A Questionnaire Survey at Danish Hospitals
This study aims to investigate the current organization and management of postoperative pain in Denmark, especially for invasive pain treatment modalities (epidural infusions, PCA and regional blocks), in a national survey covering the activities in Danish Hospitals.
This study is an electronic questionnaire survey, that aim to describe and map the foundation for future developments within, and improvement of, postoperative pain management.
Read the detailed description
Postoperative pain is one of the major challenges in postoperative care and several studies continue to demonstrate that postoperative pain is generally undertreated. A key focus for postoperative pain is to identify gold standards within procedure-specific pain treatment. However, results from single randomized trials do not per se lead to better treatment, as this requires both efforts within implementation of best evidence, quality control of efficacy, including efficacy on the individual level, and education of staff and physicians.
It has been suggested, that a way forward must include changes at the organizational level. For basic postoperative pain treatment, the major responsibility for planning and execution often rests on the surgical departments. For invasive pain treatment methods, e.g. epidural analgesia with continual infusion, patient controlled epidural analgesia (PCEA), patient controlled analgesia (PCA), and regional blocks, both single and continuing, this treatment is instituted at the departments of anaesthesia, but the responsibility for follow up is rarely described.
Generally, epidural analgesia is widely recommended because of superior benefits in reducing postoperative pain, pulmonal complications and surgical stress, as compared to systemic opioid treatment. However, epidural analgesia is not without complications especially not for abdominal and thoracic surgery. The accompanying unwanted motor blockade may delay recovery and recent studies question this treatment. Likewise, up to 20 % percent of patients will not receive adequate analgesia for the first 48 hours postoperative with this method. Finally, it is possible, that adverse effects and complications from epidural treatment are currently being underestimated, due to lack of routine monitoring and missing protocols.
Besides epidural analgesia, the use of Patient controlled analgesia (PCA), Patient controlled epidural analgesia (PCEA) and regional blocks have gained ground the last decades. With these techniques it might be possible to reduce overall opioid requirements. Nevertheless, a daily evaluation of benefits and harms of such analgesic techniques may be required to justify these treatment modalities. It is suggested, that regularly monitoring of invasive analgesic methods is of great concern when it comes to optimal postoperative pain management and reduction of adverse effects.
A structured organizational approach has the potential to improve benefit and harm of postoperative pain management. A number of studies argues that in order to obtain optimal postoperative pain treatment there need to be regular monitoring, and optimization of the analgesic regimens and techniques, preferably in a clinical setting with either an Acute Pain Service (APS) or a similar setup. With the decline of the use of APS's in Denmark it seems that the organization and management around postoperative pain treatment in general, and for invasive pain treatment methods in particular, needs to be investigated. As of today, it is not known how patients with such pain treatment are monitored and taken care of after leaving the post anaesthesia care unit, and where the responsibility for this pain treatment lies
- Conditions
- Pain, Postoperative, Anesthesia, Epidural Analgesia, Acute Pain
- Medical subject headings
- Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Head of Post Anaesthesia Care Unit | The chief physician of PACUs at all Danish Anaesthesia departments will receive electronic survey on postoperative pain treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of hospitals, with a department of anesthesia, providing postoperative monitoring of epidural analgesia on postoperative day (POD) one.
The respondent will answer the question: "What invasive pain treatments are routinely inspected by the department of anesthesia" and choose from a list of options: "No", "Yes 1. POD", "Yes 2. POD", "Yes 3. POD" or "other": the respondent will specify.
Measured: From april 15th to may 1st 2018.
Secondary outcomes (19)
Size of hospital (number of beds)
Number of beds
Measured: From april 15th to may 1st 2018.
Number of Post Anesthesia Care Units (PACU)
Number of PACU's
Measured: From april 15th to may 1st 2018.
Size of PACU (number of beds)
Number of beds
Measured: From april 15th to may 1st 2018.
Availability of a well defined acute pain unit with connected personnel
The respondent will choose "yes", "no" or "don't know"
Measured: From april 15th to may 1st 2018.
Availability of a chronical pain unit/pain clinic
The respondent will choose "yes", "no" or "don't know"
Measured: From april 15th to may 1st 2018.
Availability of a specialized pain unit for children
The respondent will choose "yes", "no" or "don't know"
Measured: From april 15th to may 1st 2018.
Involvement of the department of anesthesia in inspection of patients with postoperative pain
The respondent will choose from a list of options: "On request from the ward", "Agreements on certain types of patients", "As a part of the work of the Acute Pain Service", "As part of the work of the chronical pain team", "We don't make inspections" or "Other": the respondent will specify.
Measured: From april 15th to may 1st 2018.
Availability of a general protocol for postoperative pain in the PACU?
The respondent will choose "yes", "no" or "don't know"
Measured: From april 15th to may 1st 2018.
Availability of a procedure specific protocol for postoperative pain
The respondent will choose "yes", "no" or "don't know"
Measured: From april 15th to may 1st 2018.
Elaboration on the availability of a procedure specific protocol for postoperative pain between specialties
The respondent will choose "yes", "no", "not relevant for my department" or "don't know" for each specialty
Measured: From april 15th to may 1st 2018.
Availability of protocols for perioperative management for patients with complicated pain issues and/or high opioid consumption
The respondent will choose "yes", "no" or "don't know"
Measured: From april 15th to may 1st 2018.
Follow-up for patients with complicated pain issues after discharge from the hospital
The respondent will choose from a list of options: "Yes at the surgical department", "Yes at the multidisciplinary pain team/ chronical pain unit", "Yes at the local physician", "No follow-up", "Don't know" or "Other": the respondent will specify.
Measured: From april 15th to may 1st 2018.
Type of invasive pain treatment offered
The respondent will choose from a list of options: "Epidural Pain Catheter", "PCEA", "PCA", "Regional Block (single shot)", "Regional Block (continual infusion)", "Regional Block (patient controlled bolus)", "Other": the respondent will specify og "No, none of the above"
Measured: From april 15th to may 1st 2018.
Daily responsibility for follow-up/control of invasive pain treatment when the patients leave the PACU
The respondent will choose from a list of options: "Department of anesthesia", "The ward", "Don't know" or "Other": the respondent will specify
Measured: From april 15th to may 1st 2018.
Routinely inspection by the department of anesthesia of the invasive pain treatment
The respondent will choose from a list of options:"No", "Yes 1. POD", "Yes 2. POD", "Yes 3. POD" or "other": the respondent will specify for each invasive pain treatment offered at the hospital.
Measured: From april 15th to may 1st 2018.
Routinely inspection by the department of anesthesia of the invasive pain treatment with regards to involved personnel
The respondent will choose from a list of options: "Physician", "Nurse", "Acute pain team", "Chronical pain unit" or "Other": the respondent will specify.
Measured: From april 15th to may 1st 2018.
Decisions on removal and duration of treatment with an epidural catheter
The respondent will choose from a list of options: "Department of anesthesia", "The ward", "Don't know" or "Other": the respondent will specify.
Measured: From april 15th to may 1st 2018.
Involvement of the department of anesthesia in extension of the invasive pain treatment
The respondent will choose from a list of options: "Yes, every time", "Yes often", "Yes rarely", "No never" or "Don't know"
Measured: From april 15th to may 1st 2018.
Participation of the department of anesthesia in other activities regarding postoperative pain treatment
The respondent will choose from a list of options: "Education in pain treatment", "Departmental quality assesment including guidelines and audits), "Implementation", "Research" or "Other": the respondent will specify.
Measured: From april 15th to may 1st 2018.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start13 Apr 2018
- Primary completion5 May 2018
- Study completion6 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura S Kruuse, Med.Student, Principal investigator, Centre for Anaesthesiological research (CAR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496194
- Sponsor's protocol ID
- ZUH
- Status last verified
- Apr 2018
- First submitted
- 15 Mar 2018
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.
PubMed 12873949Mathiesen O, Thomsen BA, Kitter B, Dahl JB, Kehlet H. Need for improved treatment of postoperative pain. Dan Med J. 2012 Apr;59(4):A4401.
PubMed 22459715White PF, Kehlet H. Improving postoperative pain management: what are the unresolved issues? Anesthesiology. 2010 Jan;112(1):220-5. doi: 10.1097/ALN.0b013e3181c6316e. No abstract available.
PubMed 20010418Ready LB, Oden R, Chadwick HS, Benedetti C, Rooke GA, Caplan R, Wild LM. Development of an anesthesiology-based postoperative pain management service. Anesthesiology. 1988 Jan;68(1):100-6. doi: 10.1097/00000542-198801000-00016. No abstract available.
PubMed 3337359Nielsen PR, Christensen PA, Meyhoff CS, Werner MU. Post-operative pain treatment in Denmark from 2000 to 2009: a nationwide sequential survey on organizational aspects. Acta Anaesthesiol Scand. 2012 Jul;56(6):686-94. doi: 10.1111/j.1399-6576.2012.02662.x. Epub 2012 Mar 5.
PubMed 22385392Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
PubMed 26509324Rawal N. Epidural technique for postoperative pain: gold standard no more? Reg Anesth Pain Med. 2012 May-Jun;37(3):310-7. doi: 10.1097/AAP.0b013e31825735c6.
PubMed 22531384Burstal R, Wegener F, Hayes C, Lantry G. Epidural analgesia: prospective audit of 1062 patients. Anaesth Intensive Care. 1998 Apr;26(2):165-72. doi: 10.1177/0310057X9802600206.
PubMed 9564395Breivik H, Norum HM. [Regional analgesia--risks and benefits]. Tidsskr Nor Laegeforen. 2010 Feb 25;130(4):392-7. doi: 10.4045/tidsskr.08.0220. Norwegian.
PubMed 20220867Golster M. Seven years of patient-controlled epidural analgesia in a Swedish hospital: a prospective survey. Eur J Anaesthesiol. 2014 Nov;31(11):589-96. doi: 10.1097/EJA.0000000000000105.
PubMed 24922048Duncan F. Prospective observational study of postoperative epidural analgesia for major abdominal surgery. J Clin Nurs. 2011 Jul;20(13-14):1870-9. doi: 10.1111/j.1365-2702.2011.03752.x. Epub 2011 May 25.
PubMed 21615577
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anaesthesiological Involvement in Postoperative Pain Treatment - A Questionnaire Survey at Danish Hospitals
- ClinicalTrials.gov ID
- NCT03496194
- Acronym / sponsor ID
- ZUH
- Conditions
- Pain, Postoperative, Anesthesia, Epidural Analgesia, Acute Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 5 May 2018 (actual)
- Study completion
- 6 Jun 2018 (actual)
- First posted
- 12 Apr 2018 (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 investigate the current organization and management of postoperative pain in Denmark, especially for invasive pain treatment modalities (epidural infusions, PCA and regional blocks), in a national survey covering the activities in Danish Hospitals.
This study is an electronic questionnaire survey, that aim to describe and map the foundation for future developments within, and improvement of, postoperative pain management.
Detailed description
Postoperative pain is one of the major challenges in postoperative care and several studies continue to demonstrate that postoperative pain is generally undertreated. A key focus for postoperative pain is to identify gold standards within procedure-specific pain treatment. However, results from single randomized trials do not per se lead to better treatment, as this requires both efforts within implementation of best evidence, quality control of efficacy, including efficacy on the individual level, and education of staff and physicians.
It has been suggested, that a way forward must include changes at the organizational level. For basic postoperative pain treatment, the major responsibility for planning and execution often rests on the surgical departments. For invasive pain treatment methods, e.g. epidural analgesia with continual infusion, patient controlled epidural analgesia (PCEA), patient controlled analgesia (PCA), and regional blocks, both single and continuing, this treatment is instituted at the departments of anaesthesia, but the responsibility for follow up is rarely described.
Generally, epidural analgesia is widely recommended because of superior benefits in reducing postoperative pain, pulmonal complications and surgical stress, as compared to systemic opioid treatment. However, epidural analgesia is not without complications especially not for abdominal and thoracic surgery. The accompanying unwanted motor blockade may delay recovery and recent studies question this treatment. Likewise, up to 20 % percent of patients will not receive adequate analgesia for the first 48 hours postoperative with this method. Finally, it is possible, that adverse effects and complications from epidural treatment are currently being underestimated, due to lack of routine monitoring and missing protocols.
Besides epidural analgesia, the use of Patient controlled analgesia (PCA), Patient controlled epidural analgesia (PCEA) and regional blocks have gained ground the last decades. With these techniques it might be possible to reduce overall opioid requirements. Nevertheless, a daily evaluation of benefits and harms of such analgesic techniques may be required to justify these treatment modalities. It is suggested, that regularly monitoring of invasive analgesic methods is of great concern when it comes to optimal postoperative pain management and reduction of adverse effects.
A structured organizational approach has the potential to improve benefit and harm of postoperative pain management. A number of studies argues that in order to obtain optimal postoperative pain treatment there need to be regular monitoring, and optimization of the analgesic regimens and techniques, preferably in a clinical setting with either an Acute Pain Service (APS) or a similar setup. With the decline of the use of APS's in Denmark it seems that the organization and management around postoperative pain treatment in general, and for invasive pain treatment methods in particular, needs to be investigated. As of today, it is not known how patients with such pain treatment are monitored and taken care of after leaving the post anaesthesia care unit, and where the responsibility for this pain treatment lies
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head of Post Anaesthesia Care Unit | – | –The chief physician of PACUs at all Danish Anaesthesia departments will receive electronic survey on postoperative pain treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chief physicians for the postoperative care unit (PACU) at all Danish Departments of Anaesthesia
Key inclusion criteria (1 listed)
- All departments of anesthesia with a PACU in Denmark
Key exclusion criteria (1 listed)
- PACUs as part of day case surgery will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of hospitals, with a department of anesthesia, providing postoperative monitoring of epidural analgesia on postoperative day (POD) one.
Time frame: From april 15th to may 1st 2018.
The respondent will answer the question: "What invasive pain treatments are routinely inspected by the department of anesthesia" and choose from a list of options: "No", "Yes 1. POD", "Yes 2. POD", "Yes 3. POD" or "other": the respondent will specify.
19 secondary outcomes
Size of hospital (number of beds)
Time frame: From april 15th to may 1st 2018.
Number of Post Anesthesia Care Units (PACU)
Time frame: From april 15th to may 1st 2018.
Size of PACU (number of beds)
Time frame: From april 15th to may 1st 2018.
Availability of a well defined acute pain unit with connected personnel
Time frame: From april 15th to may 1st 2018.
Availability of a chronical pain unit/pain clinic
Time frame: From april 15th to may 1st 2018.
Availability of a specialized pain unit for children
Time frame: From april 15th to may 1st 2018.
Involvement of the department of anesthesia in inspection of patients with postoperative pain
Time frame: From april 15th to may 1st 2018.
Availability of a general protocol for postoperative pain in the PACU?
Time frame: From april 15th to may 1st 2018.
Availability of a procedure specific protocol for postoperative pain
Time frame: From april 15th to may 1st 2018.
Elaboration on the availability of a procedure specific protocol for postoperative pain between specialties
Time frame: From april 15th to may 1st 2018.
Availability of protocols for perioperative management for patients with complicated pain issues and/or high opioid consumption
Time frame: From april 15th to may 1st 2018.
Follow-up for patients with complicated pain issues after discharge from the hospital
Time frame: From april 15th to may 1st 2018.
Type of invasive pain treatment offered
Time frame: From april 15th to may 1st 2018.
Daily responsibility for follow-up/control of invasive pain treatment when the patients leave the PACU
Time frame: From april 15th to may 1st 2018.
Routinely inspection by the department of anesthesia of the invasive pain treatment
Time frame: From april 15th to may 1st 2018.
Routinely inspection by the department of anesthesia of the invasive pain treatment with regards to involved personnel
Time frame: From april 15th to may 1st 2018.
Decisions on removal and duration of treatment with an epidural catheter
Time frame: From april 15th to may 1st 2018.
Involvement of the department of anesthesia in extension of the invasive pain treatment
Time frame: From april 15th to may 1st 2018.
Participation of the department of anesthesia in other activities regarding postoperative pain treatment
Time frame: From april 15th to may 1st 2018.
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 18 Nov 2021.
- Background: PubMed 12873949Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.
- Background: PubMed 22459715Mathiesen O, Thomsen BA, Kitter B, Dahl JB, Kehlet H. Need for improved treatment of postoperative pain. Dan Med J. 2012 Apr;59(4):A4401.
- Background: PubMed 20010418White PF, Kehlet H. Improving postoperative pain management: what are the unresolved issues? Anesthesiology. 2010 Jan;112(1):220-5. doi: 10.1097/ALN.0b013e3181c6316e. No abstract available.
- Background: PubMed 3337359Ready LB, Oden R, Chadwick HS, Benedetti C, Rooke GA, Caplan R, Wild LM. Development of an anesthesiology-based postoperative pain management service. Anesthesiology. 1988 Jan;68(1):100-6. doi: 10.1097/00000542-198801000-00016. No abstract available.
- Background: PubMed 22385392Nielsen PR, Christensen PA, Meyhoff CS, Werner MU. Post-operative pain treatment in Denmark from 2000 to 2009: a nationwide sequential survey on organizational aspects. Acta Anaesthesiol Scand. 2012 Jul;56(6):686-94. doi: 10.1111/j.1399-6576.2012.02662.x. Epub 2012 Mar 5.
- Background: PubMed 26509324Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
- Background: PubMed 22531384Rawal N. Epidural technique for postoperative pain: gold standard no more? Reg Anesth Pain Med. 2012 May-Jun;37(3):310-7. doi: 10.1097/AAP.0b013e31825735c6.
- Background: PubMed 9564395Burstal R, Wegener F, Hayes C, Lantry G. Epidural analgesia: prospective audit of 1062 patients. Anaesth Intensive Care. 1998 Apr;26(2):165-72. doi: 10.1177/0310057X9802600206.
- Background: PubMed 20220867Breivik H, Norum HM. [Regional analgesia--risks and benefits]. Tidsskr Nor Laegeforen. 2010 Feb 25;130(4):392-7. doi: 10.4045/tidsskr.08.0220. Norwegian.
- Background: PubMed 24922048Golster M. Seven years of patient-controlled epidural analgesia in a Swedish hospital: a prospective survey. Eur J Anaesthesiol. 2014 Nov;31(11):589-96. doi: 10.1097/EJA.0000000000000105.
- Background: PubMed 21615577Duncan F. Prospective observational study of postoperative epidural analgesia for major abdominal surgery. J Clin Nurs. 2011 Jul;20(13-14):1870-9. doi: 10.1111/j.1365-2702.2011.03752.x. Epub 2011 May 25.
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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.
Laura S Kruuse, Med.Student principal investigator
Centre for Anaesthesiological research (CAR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative and Anesthesia, run by Zealand University Hospital at 1 site in Denmark.
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 1 inclusion and 1 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 18 Nov 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 Denmark. 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?
Proportion of hospitals, with a department of anesthesia, providing postoperative monitoring of epidural analgesia on postoperative day (POD) one. (time frame: From april 15th to may 1st 2018.). 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 NCT03496194, which also lists 11 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 18 Nov 2021.