AnesthesiaNCT04284098
PECS Block With Bupivacaine Vs Bupivacaine and Dexmedetomidine in Modified Radical Mastectomy
A study testing General anesthesia (GA)., PECS block using bupivacaine . and PECS block using bupivacaine and dexmedetomidine in people with Anesthesia, run by Zagazig University at 1 site in Egypt.
Trial summary
The incidence of breast cancer as well as the need for surgical treatment has increased. Breast cancer surgery (BCS) is associated with many complications such as increased incidence of acute and chronic postoperative pain, postoperative nausea and vomiting (PONV), delayed hospital discharge. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Anesthesia
- What is being tested?
- General anesthesia (GA)., PECS block using bupivacaine . and PECS block using bupivacaine and dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to 1 Jul 2020
- 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 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized for modified radical mastectomy. American Society of Anesthesiologists (ASA), physical status II. Age between 21-65 year.
Who cannot join
- Patient's refusal. Preexisting coagulopathy or anti-coagulant therapy. Local infection at site of injection. Pregnancy or breast feeding. Body Mass Index (BMI) > 35kg/m². Allergy to local anesthetics and drugs used. Prior breast surgery except for diagnostic biopsies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Pectoral Nerve Block Using Bupivacaine Versus Bupivacaine and Dexmedetomidine as a Supplement to General Anesthesia in Modified Radical Mastectomy
The incidence of breast cancer as well as the need for surgical treatment has increased.
Breast cancer surgery (BCS) is associated with many complications such as increased incidence of acute and chronic postoperative pain, postoperative nausea and vomiting (PONV), delayed hospital discharge.
Read more
Acute postoperative pain is an integral risk factor in the development of chronic pain after BCS.
Inadequate pain control can impact patient recovery including impaired pulmonary and immune function with an increased risk of ileus, thromboembolism, and myocardial infarction.
General anesthesia (GA) is the technique that commonly used for breast surgeries. The downside of GA includes inadequate pain control with high incidence of PONV . Also postoperative opioid for postoperative pain usually associated with many complications Regional anesthesia for breast surgery holds a great promise for breast cancer patients in terms of improved acute pain control with chronic pain prevention. It offers adequate analgesia while minimizing opioid consumption.
This study was designed in order to assess the efficacy and safety of PECS block as a supplement to GA in modified radical mastectomy (MRM) . Also to assess its role in decreasing the amount of opioid in the intra- and postoperative period after MRM. Also to assess its role in decreasing postoperative complications after BCS such as postoperative nausea and vomiting, delayed hospital discharge,and acute postoperative pain. Also to assess the role of dexmedetomidine in prolongation of the analgesic effect of PECS block.
Read the detailed description
Breast cancer is the most frequent cancer among women; it causes the highest number of cancer-related deaths among them globally. The prognosis has improved considerably over the past 30 years, and the 5-year survival rate of patients has been increased due to the advances in the early detection and treatment of breast cancer.
Breast cancer surgery is associated with many complications such as increased incidence of acute and chronic postoperative pain, postoperative nausea and vomiting, delayed hospital discharge, and cancer recurrence. One of the most important complications is the occurrence of acute postoperative pain. Acute postoperative pain is an integral risk factor in the development of chronic pain after breast cancer surgery (BCS).
Inadequate pain control can impact patient recovery including impaired pulmonary and immune function with an increased risk of ileus, thromboembolism, and myocardial infarction. These factors can further increase the hospital length of stay, increase the healthcare costs, and decrease the patient satisfaction.
General anesthesia, including intravenous and inhalational agents, is the technique that commonly used for breast surgeries. The drawbacks of general anesthesia include inadequate pain control with high incidence of nausea and vomiting. Also the use of opioid and non-opioid analgesics for postoperative pain usually associated with many complications.
Regional anesthesia for breast surgery holds a great promise for breast cancer patients in terms of improved acute pain control with chronic pain prevention. It offers adequate analgesia while minimizing opioid consumption and its related side effects.
Several techniques of blocks for breast surgery have been described. Thoracic epidural and paravertebral blocks were the gold standard techniques to achieve this goal. However, these techniques are generally performed before general anesthesia, and not all anesthesiologists feel comfortable using such invasive procedures in BCS. AS an alternative for these techniques, pectoral nerves (PECS) block has been reported as a promising technique during BCS.
PECS block is an interfascial peripheral nerve block described since 2011.The original block is PECS I block, in which local anesthetic is deposited between the pectoralis major and pectoralis minor muscles to block the lateral pectoral nerve (C5, 6, 7) and medial pectoral nerve (C8, T1) providing analgesia to the anterior chest wall.
PECS II block is a modified PECS I. In this block, local anesthetic is injected between the serratus anterior and pectoralis minor muscle at the third rib in addition to the original block aimed to block thoracic intercostal nerves (T2-6) including intercostobrachial nerve and long thoracic nerve (C5-C7). This modification aimed to extend analgesia to the axilla; this is needed for axillary clearance, necessary for wide excisions, tumorectomy, lymph node excision and several types of mastectomies.
It differs from thoracic epidural and paravertebral blocks as there is no associated sympathetic block. It can be performed while the patient in the supine position and it can be done before or after induction of general anesthesia.
The use of ultrasound (US) makes the pectoral nerve block more accurate and less injurious to nearby structures such as the parietal pleura. It helps direct visualization of anatomical structures, it finds the possible variations in the origin, course, the accompanying structures of the medial and lateral pectoral nerves and their relation to the important structures such thoracoacromial artery and parietal pleura to avoid their injury during performing the PECS block.
The addition of dexmedetomidine to bupivacaine can improve the quality of the block, significantly prolong the duration of analgesia, and provides better pain control postoperatively without major side effects.
- Conditions
- Anesthesia
- Being tested
- General anesthesia (GA)., PECS block using bupivacaine ., PECS block using bupivacaine and dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesia (GA).Other
Patients received standard GA including fentanyl as intraoperative analgesic and morphine as postoperative analgesic in the first 24 hours.
PECS block using bupivacaine .Other
The patients undergo an ultrasound-guided PECS I using 10 ml bupivacaine 0.25% and PECS II using 20 ml bupivacaine 0.25%, after 10-minutes observation the patients receive standard GA including fentanyl as intraoperative analgesic and morphine as postoperative analgesic in the first 24 hours.
PECS block using bupivacaine and dexmedetomidineOther
D group:The patients undergo an ultrasound-guided PECS I using 10 ml bupivacaine 0.25% and PECS II using 20 ml bupivacaine 0.25%+dexmedetomidine (1µg/kg) after 10-minutes observation the patients receive standard GA including fentanyl as intraoperative analgesic and morphine as postoperative analgesic in the first 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| GA group | Placebo comparator | Group I (GA group): Standard general anesthesia (GA) . Receives: Other: General anesthesia (GA). |
| Bupivacaine group | Active comparator | Group II (B group): ultrasound-guided PECS block using bupivacaine 0.25% + standard GA. Receives: Other: PECS block using bupivacaine . |
| Dexmedetomidine&bupivacaine group | Active comparator | Group III (D group): ultrasound-guided PECS block using bupivacaine 0.25% and Dexmedetomidine 1µg/kg+standard GA. Receives: Other: PECS block using bupivacaine and dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intraoperative opioid consumption.
Total intraoperative fentanyl.
Measured: During operation.
Total postoperative opioid consumption.
Total postoperative morphine consumption.
Measured: First 24 hours after surgery.
First time to rescue analgesia.
Duration of postoperative analgesia.
Measured: First 24 hours after surgery.
Secondary outcomes (4)
Postoperative pain score.
Visual analogue scale (VAS) which is a unidimensional measure of pain intensity, it is a 10 cm line ranging from (0=no pain to 10 = worst pain imaginable) . The patient is asked to mark on this line where the intensity of the pain lies.
Measured: 0.3,6,9,12, and 24 hours after surgery.
Postoperative nausea &vomiting
postoperative nausea \&vomiting (yes or no)
Measured: First 24 hours after surgery.
Hospital length of stay.
days until the patients are discharged to home.
Measured: First 3 days after surgery.
Patients and surgeon satisfaction
Surgeon satisfaction is assessed by Surgeon Satisfaction with Anesthesia Services (SSAS) the scale was composed of four levels (Strongly disagree, Disagree, Agree, strongly agree) ,Patient satisfaction (yes or no).
Measured: First 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Thorya Mohammed Salem, Zagazig University
- Investigators
- Doaa M Farid, MD, Study chair, Faculty of medicine,Zagazig university,EgyptMaha I El desouky, MD, Study chair, Faculty of medicine,Zagazig university,EgyptFatma M Ahmed, MD, Study director, Faculty of medicine,Zagazig university,Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284098
- Sponsor's protocol ID
- PECS in Breast Cancer Surgery
- Status last verified
- Feb 2020
- First submitted
- 14 Feb 2020
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Battista C, Krishnan S. Pectoralis Nerve Block. 2023 Jul 25. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK547691/
PubMed 31613471Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223.
PubMed 27543533Besch G, Lagrave-Safranez C, Ecarnot F, De Larminat V, Gay C, Berthier F, Samain E, Pili-Floury S. Pectoral nerve block and persistent pain following breast cancer surgery: an observational cohort study. Minerva Anestesiol. 2018 Jun;84(6):769-771. doi: 10.23736/S0375-9393.18.12544-2. Epub 2018 Feb 15. No abstract available.
PubMed 29469548Campos M, Azevedo J, Mendes L, Rebelo H. Pectoral nerve block as a single anesthetic technique for breast surgery and sentinel lymph node investigation. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Nov;65(9):534-536. doi: 10.1016/j.redar.2018.05.005. Epub 2018 Jul 21. English, Spanish.
PubMed 30037430Turbitt L, Nelligan K, McCartney C. Pectoral Nerve Blocks for Breast Cancer Surgery: A Methodological Evaluation. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):388-9. doi: 10.1097/AAP.0000000000000226. No abstract available.
PubMed 26079354
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Pectoral Nerve Block Using Bupivacaine Versus Bupivacaine and Dexmedetomidine as a Supplement to General Anesthesia in Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT04284098
- Acronym / sponsor ID
- PECS in Breast Cancer Surgery
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 25 Feb 2020 (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.
The incidence of breast cancer as well as the need for surgical treatment has increased.
Breast cancer surgery (BCS) is associated with many complications such as increased incidence of acute and chronic postoperative pain, postoperative nausea and vomiting (PONV), delayed hospital discharge.
Acute postoperative pain is an integral risk factor in the development of chronic pain after BCS.
Inadequate pain control can impact patient recovery including impaired pulmonary and immune function with an increased risk of ileus, thromboembolism, and myocardial infarction.
General anesthesia (GA) is the technique that commonly used for breast surgeries. The downside of GA includes inadequate pain control with high incidence of PONV . Also postoperative opioid for postoperative pain usually associated with many complications Regional anesthesia for breast surgery holds a great promise for breast cancer patients in terms of improved acute pain control with chronic pain prevention. It offers adequate analgesia while minimizing opioid consumption.
This study was designed in order to assess the efficacy and safety of PECS block as a supplement to GA in modified radical mastectomy (MRM) . Also to assess its role in decreasing the amount of opioid in the intra- and postoperative period after MRM. Also to assess its role in decreasing postoperative complications after BCS such as postoperative nausea and vomiting, delayed hospital discharge,and acute postoperative pain. Also to assess the role of dexmedetomidine in prolongation of the analgesic effect of PECS block.
Detailed description
Breast cancer is the most frequent cancer among women; it causes the highest number of cancer-related deaths among them globally. The prognosis has improved considerably over the past 30 years, and the 5-year survival rate of patients has been increased due to the advances in the early detection and treatment of breast cancer.
Breast cancer surgery is associated with many complications such as increased incidence of acute and chronic postoperative pain, postoperative nausea and vomiting, delayed hospital discharge, and cancer recurrence. One of the most important complications is the occurrence of acute postoperative pain. Acute postoperative pain is an integral risk factor in the development of chronic pain after breast cancer surgery (BCS).
Inadequate pain control can impact patient recovery including impaired pulmonary and immune function with an increased risk of ileus, thromboembolism, and myocardial infarction. These factors can further increase the hospital length of stay, increase the healthcare costs, and decrease the patient satisfaction.
General anesthesia, including intravenous and inhalational agents, is the technique that commonly used for breast surgeries. The drawbacks of general anesthesia include inadequate pain control with high incidence of nausea and vomiting. Also the use of opioid and non-opioid analgesics for postoperative pain usually associated with many complications.
Regional anesthesia for breast surgery holds a great promise for breast cancer patients in terms of improved acute pain control with chronic pain prevention. It offers adequate analgesia while minimizing opioid consumption and its related side effects.
Several techniques of blocks for breast surgery have been described. Thoracic epidural and paravertebral blocks were the gold standard techniques to achieve this goal. However, these techniques are generally performed before general anesthesia, and not all anesthesiologists feel comfortable using such invasive procedures in BCS. AS an alternative for these techniques, pectoral nerves (PECS) block has been reported as a promising technique during BCS.
PECS block is an interfascial peripheral nerve block described since 2011.The original block is PECS I block, in which local anesthetic is deposited between the pectoralis major and pectoralis minor muscles to block the lateral pectoral nerve (C5, 6, 7) and medial pectoral nerve (C8, T1) providing analgesia to the anterior chest wall.
PECS II block is a modified PECS I. In this block, local anesthetic is injected between the serratus anterior and pectoralis minor muscle at the third rib in addition to the original block aimed to block thoracic intercostal nerves (T2-6) including intercostobrachial nerve and long thoracic nerve (C5-C7). This modification aimed to extend analgesia to the axilla; this is needed for axillary clearance, necessary for wide excisions, tumorectomy, lymph node excision and several types of mastectomies.
It differs from thoracic epidural and paravertebral blocks as there is no associated sympathetic block. It can be performed while the patient in the supine position and it can be done before or after induction of general anesthesia.
The use of ultrasound (US) makes the pectoral nerve block more accurate and less injurious to nearby structures such as the parietal pleura. It helps direct visualization of anatomical structures, it finds the possible variations in the origin, course, the accompanying structures of the medial and lateral pectoral nerves and their relation to the important structures such thoracoacromial artery and parietal pleura to avoid their injury during performing the PECS block.
The addition of dexmedetomidine to bupivacaine can improve the quality of the block, significantly prolong the duration of analgesia, and provides better pain control postoperatively without major side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GA group | Placebo comparator | Other: General anesthesia (GA).Group I (GA group): Standard general anesthesia (GA) . |
| Bupivacaine group | Active comparator | Other: PECS block using bupivacaine .Group II (B group): ultrasound-guided PECS block using bupivacaine 0.25% + standard GA. |
| Dexmedetomidine&bupivacaine group | Active comparator | Other: PECS block using bupivacaine and dexmedetomidineGroup III (D group): ultrasound-guided PECS block using bupivacaine 0.25% and Dexmedetomidine 1µg/kg+standard GA. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitalized for modified radical mastectomy. American Society of Anesthesiologists (ASA), physical status II. Age between 21-65 year.
Key exclusion criteria (1 listed)
- Patient's refusal. Preexisting coagulopathy or anti-coagulant therapy. Local infection at site of injection. Pregnancy or breast feeding. Body Mass Index (BMI) > 35kg/m². Allergy to local anesthetics and drugs used. Prior breast surgery except for diagnostic biopsies.
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 |
|---|---|---|
| General anesthesia (GA).Patients received standard GA including fentanyl as intraoperative analgesic and morphine as postoperative analgesic in the first 24 hours. | Other | GA group |
| PECS block using bupivacaine .The patients undergo an ultrasound-guided PECS I using 10 ml bupivacaine 0.25% and PECS II using 20 ml bupivacaine 0.25%, after 10-minutes observation the patients receive standard GA including fentanyl as intraoperative analgesic and morphine as postoperative analgesic in the first 24 hours. | Other | Bupivacaine group |
| PECS block using bupivacaine and dexmedetomidineD group:The patients undergo an ultrasound-guided PECS I using 10 ml bupivacaine 0.25% and PECS II using 20 ml bupivacaine 0.25%+dexmedetomidine (1µg/kg) after 10-minutes observation the patients receive standard GA including fentanyl as intraoperative analgesic and morphine as postoperative analgesic in the first 24 hours. | Other | Dexmedetomidine&bupivacaine group |
Primary outcome
Total intraoperative opioid consumption.
Time frame: During operation.
Total intraoperative fentanyl.
Total postoperative opioid consumption.
Time frame: First 24 hours after surgery.
Total postoperative morphine consumption.
First time to rescue analgesia.
Time frame: First 24 hours after surgery.
Duration of postoperative analgesia.
4 secondary outcomes
Postoperative pain score.
Time frame: 0.3,6,9,12, and 24 hours after surgery.
Postoperative nausea &vomiting
Time frame: First 24 hours after surgery.
Hospital length of stay.
Time frame: First 3 days after surgery.
Patients and surgeon satisfaction
Time frame: First 24 hours after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Background: PubMed 31613471Battista C, Krishnan S. Pectoralis Nerve Block. 2023 Jul 25. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK547691/
- Background: PubMed 27543533Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223.
- Background: PubMed 29469548Besch G, Lagrave-Safranez C, Ecarnot F, De Larminat V, Gay C, Berthier F, Samain E, Pili-Floury S. Pectoral nerve block and persistent pain following breast cancer surgery: an observational cohort study. Minerva Anestesiol. 2018 Jun;84(6):769-771. doi: 10.23736/S0375-9393.18.12544-2. Epub 2018 Feb 15. No abstract available.
- Background: PubMed 30037430Campos M, Azevedo J, Mendes L, Rebelo H. Pectoral nerve block as a single anesthetic technique for breast surgery and sentinel lymph node investigation. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Nov;65(9):534-536. doi: 10.1016/j.redar.2018.05.005. Epub 2018 Jul 21. English, Spanish.
- Background: PubMed 26079354Turbitt L, Nelligan K, McCartney C. Pectoral Nerve Blocks for Breast Cancer Surgery: A Methodological Evaluation. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):388-9. doi: 10.1097/AAP.0000000000000226. No abstract available.
- 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.
Doaa M Farid, MD study chair
Faculty of medicine,Zagazig university,Egypt
Maha I El desouky, MD study chair
Faculty of medicine,Zagazig university,Egypt
Fatma M Ahmed, MD study director
Faculty of medicine,Zagazig university,Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General anesthesia (GA)., PECS block using bupivacaine . and PECS block using bupivacaine and dexmedetomidine in people with Anesthesia, run by Zagazig University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 25 Feb 2020. 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 Egypt. 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. Some participants in this study may receive a placebo. 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 Thorya M Salem, MSc (+201006995112, dr_2010@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total intraoperative opioid consumption. (time frame: During operation.). The study lists 3 primary outcomes in all. 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 NCT04284098, which also lists 5 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 25 Feb 2020.