ChildrenNCT04031196
Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Laparoscopic Appendicectomy
A study testing QLB and TAP block in people with Children and Appendicitis, run by Zagazig University at 1 site in Egypt.
Trial summary
QL block has been recently described for chronic pain following abdominal hernia repair, and for postoperative analgesia following abdominal surgery as it leads to complete pain relief in the dermatomal area from (T6 - L1). Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Children, Appendicitis
- What is being tested?
- QLB and TAP block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to 1 Jul 2019
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- parent and patient acceptance,
- Children 7-12 years old,
- 20-35kg bodyweight,
- ASA I-II,
- and scheduled for Laparoscopic appendicectomy
Who cannot join
- Patients refusing regional anesthesia,
- those with bleeding disorders,
- skin lesion at the needle insertion site,
- sepsis,
- liver disease,
- peritonitis,
- and emergency cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Laparoscopic Appendicectomy: A Randomized Clinical Study
QL block has been recently described for chronic pain following abdominal hernia repair, and for postoperative analgesia following abdominal surgery as it leads to complete pain relief in the dermatomal area from (T6 - L1). Theoretically, QL blocks might give better and longer-lasting analgesia compared to the US-guided anterior TAP block due to a spread to the thoracic paravertebral space and sympathetic nerves in the thoracolumbar fascia, so visceral afferent pathways to the medulla can be blocked.
Read the detailed description
Recently, the laparoscopic technique has been successfully used for many pediatric surgical cases. The laparoscopic appendicectomy is favored over the traditional open method, as it has a lower incidence of postoperative surgical complications and faster recovery to normal daily activities. Although it is considered as minimally invasive surgery, patients may require hospitalization for over 24 hours following laparoscopic appendicectomy, and postoperative pain which is caused by the surgical wound and visceroperitonitic pain as a result of peritoneal inflammation and infection, may extend the length of hospital stay.
Regional anesthesia techniques are commonly enhanced for pain management in pediatric surgical procedure as they decrease parenteral opioid requirements and improve patient-parent satisfaction [6].
The Transversus Abdominis Plane (TAP) block was first described in 2004 by McDonnell et al. using anatomical landmark guidance, and ultrasound-guided technique was later popularized by Hebbard et al. TAP block is aiming to block sensory nerves that course between the transversus abdominis and internal oblique muscles and supply the anterior abdominal wall, where local anesthetic is injected into the transversus abdominis fascial plane. Many clinical studies have reported the efficacy of TAP block in providing adequate postoperative analgesia for lower abdominal surgery.
Quadratus Lumborum block was initially described by R.Blanco as an abstract at the annual European Society of Regional Anaesthesia (ESRA) congress in 2007, where the local anesthetic (LA) was injected in the anterolateral aspect of the QL muscle (type 1 QL block). Later, J. Børglum used posterior transmuscular approach by detecting Shamrock sign and injecting the LA in the anterior aspect of the QL (type 3 QL block). Recently, R. Blanco described another approach by injecting the LA in the posterior aspect of the QL muscle (type 2 QL block), which may be easier and safer as the LA is injected in a more superficial plane, so the risk of intra-abdominal complications and lumbar plexus injuries is reduced. And finally the intramuscular QL block (type 4 QL block), the local anesthetic is injected directly into the QL muscle.
We hypothesize that ultrasound-guided QL block will be more superior than or equal to TAP block in providing postoperative analgesia for children undergoing laparoscopic appendicectomy.
- Conditions
- Children, Appendicitis
- Being tested
- QLB, TAP block
- Keywords
- Pediatric, Quadratus Lumborum, regional anesthesia
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLBProcedure or surgery
QLB type 2 approach
TAP blockProcedure or surgery
classic TAP block approach
| Study group | Role | What they receive |
|---|---|---|
| QLB group, Quadratus Lumborum Block group | Active comparator | the patient placed in the lateral decubitus position, the low-frequency convex probe of Sonosite M Turbo ultrasonography was placed in the anterior axillary line midway between subcostal margin and iliac crest to identify the abdominal muscle layers, then the probe was moved to the posterior axillary line to visualize the quadratus lumborum muscle attached to the transverse process of the L4, With the psoas major muscle placed anteriorly, the erector spinae muscle posteriorly, a 22-gauge, 80 mm needle was inserted in-plane into the posterior aspect of QL muscle (between quadratus lumborum and erector spinae muscle), and then 0.5ml/kg of 0.25% levobupivacaine local anesthetic was injected behind the muscle as a bolus dose. The block was performed bilaterally. Receives: Procedure: QLB |
| TAP block group,Transversus Abdominis Plane Block group | Active comparator | patient placed in the supine position, a linear multifrequency 6-13 MHz probe of Sonosite M Turbo ultrasonography was placed posterior to the midaxillary line at the midpoint between the inferior costal margin and the iliac crest, a 22-gauge, 50 mm needle was placed using an in-plane technique between the internal oblique and transversus abdominis muscle then local anesthetic was injected in a bolus dose 0.5ml/kg of 0.25% levobupivacaine, the block was done bilaterally.. after ultrasound Identification of the plane between the internal oblique and transversus abdominis muscle, Receives: Procedure: TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in intraoperative mean arterial blood pressure (MAP) values
(mm Hg)
Measured: at base line (To), 3 minutes(min) after induction of general anesthesia, 10 min after intubation (immediately before performing the block (T1)), 15 min after performing the block (T2),and intraoperative values every 15 min till the end of surgery(T3)
changes in intraoperative heart rate (HR) values
(beats/minute)
Measured: at base line (To), 3 minutes(min) after induction of general anesthesia, 10 min after intubation (immediately before performing the block (T1)), 15 min after performing the block (T2),and intraoperative values every 15 min till the end of surgery(T3)
changes in the degree of pain perception by patient
measured by visual analogue scale(VAS), The patient was trained to report the level of pain on VAS scale from 0 to 10 (where 0 indicates no pain and 10 indicates the most severe pain).
Measured: Patients were assessed in the immediate post operative period and then at 2 hour(h), 4h, 6h , 8h , 12 h, 18 h and at 24 hours postoperative for the quality of analgesia
Secondary outcomes (5)
total intraoperative fentanyl consumption
measured by μg /kg
Measured: during the time of the surgical procedure
1st time of rescue analgesics
minute
Measured: during the first postoperative 24 hours
total amount of rescue analgesic consumed
mg/kg
Measured: in the first postoperative 24 hours
post operative nausea and vomiting
by number of patients complained of these side effects
Measured: in the first postoperative 24 hours
degree of patient and parent satisfaction
5-point scale assessment (satisfied or completely satisfied, not satisfied nor dissatisfied, dissatisfied, completely dissatisfied)
Measured: at the end of the first postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start1 Oct 2018
- Primary completion1 Mar 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ChildrenStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 34 patients randomly allocated into two equal groups 17 patients in each group: Quadratus Lumborum Block" QLB group": ultrasound-guided QLB type 2 with 0.5ml/kg of 0.25% levobupivacaine local anesthetic was done to patients. and Transversus Abdominis Plane Block group (TAP block): ultrasound-guided TAP block with 0.5ml/kg of 0.25% levobupivacaine local anesthetic was done to patients.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shereen Elsayed Abd Ellatif, Zagazig University
- Investigators
- Shereen E Abd Ellatif, MD, Principal investigator, Anesthesia and Surgical Intensive Care Department, Faculty of medicine, Zagazig UniversityFatma M Ahmed, MD, Study director, Anesthesia and Surgical Intensive Care Department, Faculty of medicine, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031196
- Sponsor's protocol ID
- 5504-16-9-2018
- Status last verified
- Aug 2020
- First submitted
- 17 Jul 2019
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the IPD that underlie results in a publication
Publications
Gupta V, Yadav SK, Dean E, Vincent P, Walid F, Al Said A. Paediatric laparoscopic orchidopexy as a novel mentorship: Training model. Afr J Paediatr Surg. 2013 Apr-Jun;10(2):117-21. doi: 10.4103/0189-6725.115035.
PubMed 23860059Bharti N, Kumar P, Bala I, Gupta V. The efficacy of a novel approach to transversus abdominis plane block for postoperative analgesia after colorectal surgery. Anesth Analg. 2011 Jun;112(6):1504-8. doi: 10.1213/ANE.0b013e3182159bf8. Epub 2011 Apr 5.
PubMed 21467560Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. doi: 10.1016/j.jclinane.2010.05.008.
PubMed 21296242Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.
PubMed 24249997Tupper-Carey DA, Fathil SM, Tan YK, Kan YM, Cheong CY, Siddiqui FJ, Assam PN. A randomised controlled trial investigating the analgesic efficacy of transversus abdominis plane block for adult laparoscopic appendicectomy. Singapore Med J. 2017 Aug;58(8):481-487. doi: 10.11622/smedj.2016068. Epub 2016 Apr 8.
PubMed 27056207Murouchi T. Quadratus lumborum block intramuscular approach for pediatric surgery. Acta Anaesthesiol Taiwan. 2016 Dec;54(4):135-136. doi: 10.1016/j.aat.2016.10.003. Epub 2016 Dec 9. No abstract available.
PubMed 27939905Visoiu M, Yakovleva N. Continuous postoperative analgesia via quadratus lumborum block - an alternative to transversus abdominis plane block. Paediatr Anaesth. 2013 Oct;23(10):959-61. doi: 10.1111/pan.12240. Epub 2013 Aug 9.
PubMed 23927552Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.
PubMed 27755488
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Laparoscopic Appendicectomy: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT04031196
- Acronym / sponsor ID
- 5504-16-9-2018
- Conditions
- Children, Appendicitis
- Keywords
- Pediatric, Quadratus Lumborum, regional anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 24 Jul 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.
QL block has been recently described for chronic pain following abdominal hernia repair, and for postoperative analgesia following abdominal surgery as it leads to complete pain relief in the dermatomal area from (T6 - L1). Theoretically, QL blocks might give better and longer-lasting analgesia compared to the US-guided anterior TAP block due to a spread to the thoracic paravertebral space and sympathetic nerves in the thoracolumbar fascia, so visceral afferent pathways to the medulla can be blocked.
Detailed description
Recently, the laparoscopic technique has been successfully used for many pediatric surgical cases. The laparoscopic appendicectomy is favored over the traditional open method, as it has a lower incidence of postoperative surgical complications and faster recovery to normal daily activities. Although it is considered as minimally invasive surgery, patients may require hospitalization for over 24 hours following laparoscopic appendicectomy, and postoperative pain which is caused by the surgical wound and visceroperitonitic pain as a result of peritoneal inflammation and infection, may extend the length of hospital stay.
Regional anesthesia techniques are commonly enhanced for pain management in pediatric surgical procedure as they decrease parenteral opioid requirements and improve patient-parent satisfaction [6].
The Transversus Abdominis Plane (TAP) block was first described in 2004 by McDonnell et al. using anatomical landmark guidance, and ultrasound-guided technique was later popularized by Hebbard et al. TAP block is aiming to block sensory nerves that course between the transversus abdominis and internal oblique muscles and supply the anterior abdominal wall, where local anesthetic is injected into the transversus abdominis fascial plane. Many clinical studies have reported the efficacy of TAP block in providing adequate postoperative analgesia for lower abdominal surgery.
Quadratus Lumborum block was initially described by R.Blanco as an abstract at the annual European Society of Regional Anaesthesia (ESRA) congress in 2007, where the local anesthetic (LA) was injected in the anterolateral aspect of the QL muscle (type 1 QL block). Later, J. Børglum used posterior transmuscular approach by detecting Shamrock sign and injecting the LA in the anterior aspect of the QL (type 3 QL block). Recently, R. Blanco described another approach by injecting the LA in the posterior aspect of the QL muscle (type 2 QL block), which may be easier and safer as the LA is injected in a more superficial plane, so the risk of intra-abdominal complications and lumbar plexus injuries is reduced. And finally the intramuscular QL block (type 4 QL block), the local anesthetic is injected directly into the QL muscle.
We hypothesize that ultrasound-guided QL block will be more superior than or equal to TAP block in providing postoperative analgesia for children undergoing laparoscopic appendicectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 34 patients randomly allocated into two equal groups 17 patients in each group: Quadratus Lumborum Block" QLB group": ultrasound-guided QLB type 2 with 0.5ml/kg of 0.25% levobupivacaine local anesthetic was done to patients. and Transversus Abdominis Plane Block group (TAP block): ultrasound-guided TAP block with 0.5ml/kg of 0.25% levobupivacaine local anesthetic was done to patients.
| Arm | Type | Receives |
|---|---|---|
| QLB group, Quadratus Lumborum Block group | Active comparator | Procedure: QLBthe patient placed in the lateral decubitus position, the low-frequency convex probe of Sonosite M Turbo ultrasonography was placed in the anterior axillary line midway between subcostal margin and iliac crest to identify the abdominal muscle layers, then the probe was moved to the posterior axillary line to visualize the quadratus lumborum muscle attached to the transverse process of the L4, With the psoas major muscle placed anteriorly, the erector spinae muscle posteriorly, a 22-gauge, 80 mm needle was inserted in-plane into the posterior aspect of QL muscle (between quadratus lumborum and erector spinae muscle), and then 0.5ml/kg of 0.25% levobupivacaine local anesthetic was injected behind the muscle as a bolus dose. The block was performed bilaterally. |
| TAP block group,Transversus Abdominis Plane Block group | Active comparator | Procedure: TAP blockpatient placed in the supine position, a linear multifrequency 6-13 MHz probe of Sonosite M Turbo ultrasonography was placed posterior to the midaxillary line at the midpoint between the inferior costal margin and the iliac crest, a 22-gauge, 50 mm needle was placed using an in-plane technique between the internal oblique and transversus abdominis muscle then local anesthetic was injected in a bolus dose 0.5ml/kg of 0.25% levobupivacaine, the block was done bilaterally.. after ultrasound Identification of the plane between the internal oblique and transversus abdominis muscle, |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- parent and patient acceptance,
- Children 7-12 years old,
- 20-35kg bodyweight,
- ASA I-II,
Key exclusion criteria (7 listed)
- Patients refusing regional anesthesia,
- those with bleeding disorders,
- skin lesion at the needle insertion site,
- sepsis,
- liver disease,
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 |
|---|---|---|
| QLBQLB type 2 approach | Procedure or surgery | QLB group, Quadratus Lumborum Block group |
| TAP blockclassic TAP block approach | Procedure or surgery | TAP block group,Transversus Abdominis Plane Block group |
Primary outcome
changes in intraoperative mean arterial blood pressure (MAP) values
Time frame: at base line (To), 3 minutes(min) after induction of general anesthesia, 10 min after intubation (immediately before performing the block (T1)), 15 min after performing the block (T2),and intraoperative values every 15 min till the end of surgery(T3)
(mm Hg)
changes in intraoperative heart rate (HR) values
Time frame: at base line (To), 3 minutes(min) after induction of general anesthesia, 10 min after intubation (immediately before performing the block (T1)), 15 min after performing the block (T2),and intraoperative values every 15 min till the end of surgery(T3)
(beats/minute)
changes in the degree of pain perception by patient
Time frame: Patients were assessed in the immediate post operative period and then at 2 hour(h), 4h, 6h , 8h , 12 h, 18 h and at 24 hours postoperative for the quality of analgesia
measured by visual analogue scale(VAS), The patient was trained to report the level of pain on VAS scale from 0 to 10 (where 0 indicates no pain and 10 indicates the most severe pain).
5 secondary outcomes
total intraoperative fentanyl consumption
Time frame: during the time of the surgical procedure
1st time of rescue analgesics
Time frame: during the first postoperative 24 hours
total amount of rescue analgesic consumed
Time frame: in the first postoperative 24 hours
post operative nausea and vomiting
Time frame: in the first postoperative 24 hours
degree of patient and parent satisfaction
Time frame: at the end of the first postoperative 24 hours
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 7 Aug 2020.
- Background: PubMed 23860059Gupta V, Yadav SK, Dean E, Vincent P, Walid F, Al Said A. Paediatric laparoscopic orchidopexy as a novel mentorship: Training model. Afr J Paediatr Surg. 2013 Apr-Jun;10(2):117-21. doi: 10.4103/0189-6725.115035.
- Background: PubMed 21467560Bharti N, Kumar P, Bala I, Gupta V. The efficacy of a novel approach to transversus abdominis plane block for postoperative analgesia after colorectal surgery. Anesth Analg. 2011 Jun;112(6):1504-8. doi: 10.1213/ANE.0b013e3182159bf8. Epub 2011 Apr 5.
- Background: PubMed 21296242Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. doi: 10.1016/j.jclinane.2010.05.008.
- Background: PubMed 24249997Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.
- Background: PubMed 27056207Tupper-Carey DA, Fathil SM, Tan YK, Kan YM, Cheong CY, Siddiqui FJ, Assam PN. A randomised controlled trial investigating the analgesic efficacy of transversus abdominis plane block for adult laparoscopic appendicectomy. Singapore Med J. 2017 Aug;58(8):481-487. doi: 10.11622/smedj.2016068. Epub 2016 Apr 8.
- Background: PubMed 27939905Murouchi T. Quadratus lumborum block intramuscular approach for pediatric surgery. Acta Anaesthesiol Taiwan. 2016 Dec;54(4):135-136. doi: 10.1016/j.aat.2016.10.003. Epub 2016 Dec 9. No abstract available.
- Background: PubMed 23927552Visoiu M, Yakovleva N. Continuous postoperative analgesia via quadratus lumborum block - an alternative to transversus abdominis plane block. Paediatr Anaesth. 2013 Oct;23(10):959-61. doi: 10.1111/pan.12240. Epub 2013 Aug 9.
- Background: PubMed 27755488Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.
- Individual participant dataSharing planned: Yes. All the IPD that underlie results in a publication
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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.
Shereen E Abd Ellatif, MD principal investigator
Anesthesia and Surgical Intensive Care Department, Faculty of medicine, Zagazig University
Fatma M Ahmed, MD study director
Anesthesia and Surgical Intensive Care Department, Faculty of medicine, Zagazig 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 QLB and TAP block in people with Children and Appendicitis, 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 5 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 7 Aug 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. 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?
changes in intraoperative mean arterial blood pressure (MAP) values (time frame: at base line (To), 3 minutes(min) after induction of general anesthesia, 10 min after intubation (immediately before performing the block (T1)), 15 min after performing the block (T2),and intraoperative values every 15 min till the end of surgery(T3)). 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 NCT04031196, which also lists 8 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 7 Aug 2020.