Quadratus Lumborum BlockNCT05442905
Quadratus Lumborum Versus Transversus Abdominis Plane Block Versus Caudal Block for Postoperative Analgesia After Pediatric Inguinal Hernia : Double-Blinded Randomized Trial
A study testing propofol, Atracurium Besylate and sevoflurane in people with Quadratus Lumborum Block and Transversus Abdominis Plane Block, run by Tanta University.
Trial summary
Background: Multimodal analgesia (MMA) is the current standard practice to provide postoperative analgesia. The aim of this study is to compare the analgesic efficacy of quadratus lumborum (QL) block versus transversus abdominis plane (TAP) block versus caudal block as an adjunct to MMA. Read more about this study
- Who is it for?
- Ages 2 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Quadratus Lumborum Block, Transversus Abdominis Plane Block, Caudal Block
- What is being tested?
- propofol, Atracurium Besylate and sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 1 Mar 2023
- 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 2 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- patients of ASA physical status Ӏ or ӀӀ
- scheduled for inguinal hernia surgery
Who cannot join
- lack of consent by parents
- blood coagulopathies.
- local infection.
- vertebral deformity.
- allergy to drugs
About this study
Background: Multimodal analgesia (MMA) is the current standard practice to provide postoperative analgesia. The aim of this study is to compare the analgesic efficacy of quadratus lumborum (QL) block versus transversus abdominis plane (TAP) block versus caudal block as an adjunct to MMA.
Methods: In a prospective, randomized, controlled study, 180 children of age 2 8 years and ASA grade Ӏ and ӀӀ, undergoing elective inguinal hernia surgery will be randomly allocated into 3 groups: Group Q (n = 60) will receive USG guided QL block with 0.7mL/kg of 0.25% bupivacaine and Group C (n = 60) will receive caudal block with 1mL/kg of 0.25% bupivacaine and Group T (n = 60) will receive USG guided TAP block with 0.5mL/kg of 0.25% bupivacaine. Postoperatively, all the subjects will be assessed at 2, 4, 6, 8, 12, 18, and 24 hours. The primary outcome will be the time to first analgesic request. The secondary outcomes will be the pain scores during rest and movement, number of doses of morphine, variation in hemodynamic parameters and adverse effects, if any.
Read the detailed description
This prospective, randomized, comparative study will be conducted at Tanta University Hospitals from August 2022 to March 2023. Total 180 patients of ASA physical status Ӏ ӀӀ, aged 2-8 years, scheduled for inguinal hernia surgery will be randomized into three groups of 60 patients each, using a computer generated random number table. Exclusion criteria will include lack of consent by parents, blood coagulopathies, local infection, vertebral deformity, and allergy to drugs.
Group Q: will receive quadratus lumborum block the patient will be placed in lateral position, the probe will be placed on the crista iliaca anterior superior. After the external oblique, internal oblique, and transversus abdominis muscles will be seen, the probe will be moved to the posterior and the quadratus lumborum muscle will be observed. A 22-gauge, 80 mm insulated Quince-type needle (Uniplex; Pajunk, Geisingen, Germany) will be moved from the anterolateral plane to the posteromedial plane, and confirmation will be made using 0.5 mL/kg saline; after a negative aspiration, 0.7 mL/kg (0.25%) bupivacaine will be applied to the posterior of the quadratus lumborum muscle and the thoracolumbar fascia in between the quadratus lumborum and latissimus dorsi muscles.
Patients in: Group T: will receive TAP block with 0.7mL/kg of 0.25% bupivacaine under US guidance. A linear high frequency ultrasound probe (6-13 MHz) will be placed transversely in the mid axillary line between the iliac crest and the costal margin. The three layers of muscles, the external oblique, the internal oblique, and the transversus abdominis will be identified. Using the in-plane technique, needle will be inserted (from anterior to posterior direction) until the tip of the needle will reach between the internal oblique and the transversus abdominis. Hydro dissection with 1-2 mL saline will be done to separate the fascial layers. After the correct localization, 20 mL of the drug will beinjected with repeated aspiration to avoid the accidental intravascular injection.
Group C: will receive caudal block with 1mL/kg of 0.25% bupivacaine, with children in left lateral position. with all aseptic measures caudal block will be performed using 25 G needle in left lateral decubitus position. Needle position will be confirmed by the pop felt during penetration of the sacrococcygeal ligament, further ensured by doing whoosh test using 0.5 mL of air injection 0.25% bupivacaine 1mL/kg will be administered after negative aspiration of blood and CSF. Intraoperative hemodynamic parameters will be recorded throughout the surgery at fixed intervals (at time of skin incision then after every 5 min till the end of surgery).
All patients will be visited 1 day prior to surgery and will be explained about the anesthesia technique and perioperative course. Each patient will undergo a thorough pre anesthetic check. On arrival in OT, multipara monitoring of ECG, SpO2, NIBP will be established. Base line parameters (SpO2 , pulse rate, SBP, DBP) will be recorded. Patient will be pre medicated with glycopyrrolate 0.005mg/kg, midazolam 0.05mg/kg, and fentanyl 2µg/kg intravenously (IV) through already secured IV line, and ringer lactate infusion will be started. After pre oxygenation with 100% O2 , anesthesia will be induced with propofol 2-3mg/kg and atracurium 0.6mg/kg; endotracheal intubation will be done using appropriate size endotracheal tube. Anesthesia will be maintained with O2 :N2 O ratio 40:60 and sevoflurane(1%-2%) and atracurium 0.15mg/kg SOS. In Group T, patients will be placed in supine position and the abdomen exposed, skin and transducer will be aseptically prepared. The abdominal wall will be scanned using a linear array transducer probe(6-13 MHz) in the multibeam mode, connected to a portable ultrasound unit (S Nerve® SonoSite, Bothell, WA, USA). Probe will be placed in midline over the rectus abdominis muscle at umbilicus level and will be traced laterally to region above the iliac crest to the petit triangle. A 22 G short beveled block needle will be inserted in plane with transducer, in anterior posterior direction. After visualization of needle tip in between internal oblique and transversus abdominis fascial sheath, local anesthetic 0.7mL/kg of bupivacaine 0.25% will be deposited. Correct local anesthetic drug placement will be indicated by hypoechoic elliptical fluid pocket between these two muscles.
To maintain blinding, postoperative evaluation of pain scores will be done by an anesthesiologist, who will be not involved in administering block. Postoperative pain will be assessed by CHEOPS score in which six parameters (cry, facial expression, child verbal, torso, touch, and leg movements) are included. Duration of postoperative analgesia, total number of rescue analgesic requirement and total dose of rescue analgesic required in 24h and any side effects (hypotension, bradycardia, respiratory depression, urinary retention, postoperative nausea and vomiting) will be recorded. Pain scores ≥ 6 for rescue analgesia in form of syrup paracetamol 10mg/kg orally will be administered.
- Conditions
- Quadratus Lumborum Block, Transversus Abdominis Plane Block, Caudal Block, Postoperative Pain, Inguinal Hernia
- Being tested
- propofol, Atracurium Besylate, sevoflurane
- Medical subject headings
- Pain, Postoperative, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Also called Intravenous anesthesia
Anesthesia will be induced with propofol 2-3mg/kg
Atracurium BesylateDrug
Also called Muscle relaxant
Atracurium 0.15mg/kg used for muscle relaxation before intubation
sevofluraneDrug
Also called Inhalational anesthesia
sevoflurane(1%-2%) used during anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Quadratus lumborum block group | Active comparator | will receive quadratus lumborum block the patient will be placed in lateral position, the probe will be placed on the crista iliaca anterior superior. After the external oblique, internal oblique, and transversus abdominis muscles will be seen, the probe will be moved to the posterior and the quadratus lumborum muscle will be observed. A 22-gauge, 80 mm insulated Quince-type needle (Uniplex; Pajunk, Geisingen, Germany) will be moved from the anterolateral plane to the posteromedial plane, and confirmation will be made using 0.5 mL/kg saline; after a negative aspiration, 0.7 mL/kg (0.25%) bupivacaine will be applied to the posterior of the quadratus lumborum muscle and the thoracolumbar fascia in between the quadratus lumborum and latissimus dorsi muscles. Receives: Drug: propofol; Drug: Atracurium Besylate; Drug: sevoflurane |
| Transversus abdominis block group | Active comparator | will receive TAP block with 0.7mL/kg of 0.25% bupivacaine under US guidance. A linear high frequency ultrasound probe (6-13 MHz) will be placed transversely in the mid axillary line between the iliac crest and the costal margin. The three layers of muscles, the external oblique, the internal oblique, and the transversus abdominis will be identified. Using the in-plane technique, needle will be inserted (from anterior to posterior direction) until the tip of the needle will reach between the internal oblique and the transversus abdominis. Hydro dissection with 1-2 mL saline will be done to separate the fascial layers. After the correct localization, 20 mL of the drug will beinjected with repeated aspiration to avoid the accidental intravascular injection. Receives: Drug: propofol; Drug: Atracurium Besylate; Drug: sevoflurane |
| Caudal block group | Active comparator | will receive caudal block with 1mL/kg of 0.25% bupivacaine, with children in left lateral position. with all aseptic measures caudal block will be performed using 25 G needle in left lateral decubitus position. Needle position will be confirmed by the pop felt during penetration of the sacrococcygeal ligament, further ensured by doing whoosh test using 0.5 mL of air injection 0.25% bupivacaine 1mL/kg will be administered after negative aspiration of blood and CSF. Intraoperative hemodynamic parameters will be recorded throughout the surgery at fixed intervals (at time of skin incision then after every 5 min till the end of surgery). Receives: Drug: propofol; Drug: Atracurium Besylate; Drug: sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to first analgesic request
The time to first analgesic request is recorded by a nurse unaware about the typy of block.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quadratus Lumborum BlockStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group Q: will receive quadratus lumborum block the patient will be placed in lateral positionGroup T: will receive TAP block with 0.7mL/kg of 0.25% bupivacaine under US guidance. A linear high frequency ultrasound probe (6-13 MHz) will be placed transversely in the mid axillary line between the iliac crest and the costal margin. Group C: will receive caudal block with 1mL/kg of 0.25% bupivacaine, with children in left lateral position.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mohamed Mogahed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442905
- Sponsor's protocol ID
- 35565/6/22
- Status last verified
- Jul 2022
- First submitted
- 29 Jun 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Authors haven't decided to make individual participant data (IPD) available to other researchers yet.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Versus Transversus Abdominis Plane Block Versus Caudal Block for Postoperative Analgesia After Pediatric Inguinal Hernia : Double-Blinded Randomized Trial
- ClinicalTrials.gov ID
- NCT05442905
- Acronym / sponsor ID
- 35565/6/22
- Conditions
- Quadratus Lumborum Block, Transversus Abdominis Plane Block, Caudal Block, Postoperative Pain, Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 5 Jul 2022 (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.
Background: Multimodal analgesia (MMA) is the current standard practice to provide postoperative analgesia. The aim of this study is to compare the analgesic efficacy of quadratus lumborum (QL) block versus transversus abdominis plane (TAP) block versus caudal block as an adjunct to MMA.
Methods: In a prospective, randomized, controlled study, 180 children of age 2 8 years and ASA grade Ӏ and ӀӀ, undergoing elective inguinal hernia surgery will be randomly allocated into 3 groups: Group Q (n = 60) will receive USG guided QL block with 0.7mL/kg of 0.25% bupivacaine and Group C (n = 60) will receive caudal block with 1mL/kg of 0.25% bupivacaine and Group T (n = 60) will receive USG guided TAP block with 0.5mL/kg of 0.25% bupivacaine. Postoperatively, all the subjects will be assessed at 2, 4, 6, 8, 12, 18, and 24 hours. The primary outcome will be the time to first analgesic request. The secondary outcomes will be the pain scores during rest and movement, number of doses of morphine, variation in hemodynamic parameters and adverse effects, if any.
Detailed description
This prospective, randomized, comparative study will be conducted at Tanta University Hospitals from August 2022 to March 2023. Total 180 patients of ASA physical status Ӏ ӀӀ, aged 2-8 years, scheduled for inguinal hernia surgery will be randomized into three groups of 60 patients each, using a computer generated random number table. Exclusion criteria will include lack of consent by parents, blood coagulopathies, local infection, vertebral deformity, and allergy to drugs.
Group Q: will receive quadratus lumborum block the patient will be placed in lateral position, the probe will be placed on the crista iliaca anterior superior. After the external oblique, internal oblique, and transversus abdominis muscles will be seen, the probe will be moved to the posterior and the quadratus lumborum muscle will be observed. A 22-gauge, 80 mm insulated Quince-type needle (Uniplex; Pajunk, Geisingen, Germany) will be moved from the anterolateral plane to the posteromedial plane, and confirmation will be made using 0.5 mL/kg saline; after a negative aspiration, 0.7 mL/kg (0.25%) bupivacaine will be applied to the posterior of the quadratus lumborum muscle and the thoracolumbar fascia in between the quadratus lumborum and latissimus dorsi muscles.
Patients in: Group T: will receive TAP block with 0.7mL/kg of 0.25% bupivacaine under US guidance. A linear high frequency ultrasound probe (6-13 MHz) will be placed transversely in the mid axillary line between the iliac crest and the costal margin. The three layers of muscles, the external oblique, the internal oblique, and the transversus abdominis will be identified. Using the in-plane technique, needle will be inserted (from anterior to posterior direction) until the tip of the needle will reach between the internal oblique and the transversus abdominis. Hydro dissection with 1-2 mL saline will be done to separate the fascial layers. After the correct localization, 20 mL of the drug will beinjected with repeated aspiration to avoid the accidental intravascular injection.
Group C: will receive caudal block with 1mL/kg of 0.25% bupivacaine, with children in left lateral position. with all aseptic measures caudal block will be performed using 25 G needle in left lateral decubitus position. Needle position will be confirmed by the pop felt during penetration of the sacrococcygeal ligament, further ensured by doing whoosh test using 0.5 mL of air injection 0.25% bupivacaine 1mL/kg will be administered after negative aspiration of blood and CSF. Intraoperative hemodynamic parameters will be recorded throughout the surgery at fixed intervals (at time of skin incision then after every 5 min till the end of surgery).
All patients will be visited 1 day prior to surgery and will be explained about the anesthesia technique and perioperative course. Each patient will undergo a thorough pre anesthetic check. On arrival in OT, multipara monitoring of ECG, SpO2, NIBP will be established. Base line parameters (SpO2 , pulse rate, SBP, DBP) will be recorded. Patient will be pre medicated with glycopyrrolate 0.005mg/kg, midazolam 0.05mg/kg, and fentanyl 2µg/kg intravenously (IV) through already secured IV line, and ringer lactate infusion will be started. After pre oxygenation with 100% O2 , anesthesia will be induced with propofol 2-3mg/kg and atracurium 0.6mg/kg; endotracheal intubation will be done using appropriate size endotracheal tube. Anesthesia will be maintained with O2 :N2 O ratio 40:60 and sevoflurane(1%-2%) and atracurium 0.15mg/kg SOS. In Group T, patients will be placed in supine position and the abdomen exposed, skin and transducer will be aseptically prepared. The abdominal wall will be scanned using a linear array transducer probe(6-13 MHz) in the multibeam mode, connected to a portable ultrasound unit (S Nerve® SonoSite, Bothell, WA, USA). Probe will be placed in midline over the rectus abdominis muscle at umbilicus level and will be traced laterally to region above the iliac crest to the petit triangle. A 22 G short beveled block needle will be inserted in plane with transducer, in anterior posterior direction. After visualization of needle tip in between internal oblique and transversus abdominis fascial sheath, local anesthetic 0.7mL/kg of bupivacaine 0.25% will be deposited. Correct local anesthetic drug placement will be indicated by hypoechoic elliptical fluid pocket between these two muscles.
To maintain blinding, postoperative evaluation of pain scores will be done by an anesthesiologist, who will be not involved in administering block. Postoperative pain will be assessed by CHEOPS score in which six parameters (cry, facial expression, child verbal, torso, touch, and leg movements) are included. Duration of postoperative analgesia, total number of rescue analgesic requirement and total dose of rescue analgesic required in 24h and any side effects (hypotension, bradycardia, respiratory depression, urinary retention, postoperative nausea and vomiting) will be recorded. Pain scores ≥ 6 for rescue analgesia in form of syrup paracetamol 10mg/kg orally will be administered.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Group Q: will receive quadratus lumborum block the patient will be placed in lateral positionGroup T: will receive TAP block with 0.7mL/kg of 0.25% bupivacaine under US guidance. A linear high frequency ultrasound probe (6-13 MHz) will be placed transversely in the mid axillary line between the iliac crest and the costal margin. Group C: will receive caudal block with 1mL/kg of 0.25% bupivacaine, with children in left lateral position.
| Arm | Type | Receives |
|---|---|---|
| Quadratus lumborum block group | Active comparator | Drug: propofol, Drug: Atracurium Besylate, Drug: sevofluranewill receive quadratus lumborum block the patient will be placed in lateral position, the probe will be placed on the crista iliaca anterior superior. After the external oblique, internal oblique, and transversus abdominis muscles will be seen, the probe will be moved to the posterior and the quadratus lumborum muscle will be observed. A 22-gauge, 80 mm insulated Quince-type needle (Uniplex; Pajunk, Geisingen, Germany) will be moved from the anterolateral plane to the posteromedial plane, and confirmation will be made using 0.5 mL/kg saline; after a negative aspiration, 0.7 mL/kg (0.25%) bupivacaine will be applied to the posterior of the quadratus lumborum muscle and the thoracolumbar fascia in between the quadratus lumborum and latissimus dorsi muscles. |
| Transversus abdominis block group | Active comparator | Drug: propofol, Drug: Atracurium Besylate, Drug: sevofluranewill receive TAP block with 0.7mL/kg of 0.25% bupivacaine under US guidance. A linear high frequency ultrasound probe (6-13 MHz) will be placed transversely in the mid axillary line between the iliac crest and the costal margin. The three layers of muscles, the external oblique, the internal oblique, and the transversus abdominis will be identified. Using the in-plane technique, needle will be inserted (from anterior to posterior direction) until the tip of the needle will reach between the internal oblique and the transversus abdominis. Hydro dissection with 1-2 mL saline will be done to separate the fascial layers. After the correct localization, 20 mL of the drug will beinjected with repeated aspiration to avoid the accidental intravascular injection. |
| Caudal block group | Active comparator | Drug: propofol, Drug: Atracurium Besylate, Drug: sevofluranewill receive caudal block with 1mL/kg of 0.25% bupivacaine, with children in left lateral position. with all aseptic measures caudal block will be performed using 25 G needle in left lateral decubitus position. Needle position will be confirmed by the pop felt during penetration of the sacrococcygeal ligament, further ensured by doing whoosh test using 0.5 mL of air injection 0.25% bupivacaine 1mL/kg will be administered after negative aspiration of blood and CSF. Intraoperative hemodynamic parameters will be recorded throughout the surgery at fixed intervals (at time of skin incision then after every 5 min till the end of surgery). |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- patients of ASA physical status Ӏ or ӀӀ
- scheduled for inguinal hernia surgery
Key exclusion criteria (5 listed)
- lack of consent by parents
- blood coagulopathies.
- local infection.
- vertebral deformity.
- allergy to drugs
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 |
|---|---|---|
| propofolAlso: Intravenous anesthesiaAnesthesia will be induced with propofol 2-3mg/kg | Drug | Caudal block group, Quadratus lumborum block group, Transversus abdominis block group |
| Atracurium BesylateAlso: Muscle relaxantAtracurium 0.15mg/kg used for muscle relaxation before intubation | Drug | Caudal block group, Quadratus lumborum block group, Transversus abdominis block group |
| sevofluraneAlso: Inhalational anesthesiasevoflurane(1%-2%) used during anesthesia | Drug | Caudal block group, Quadratus lumborum block group, Transversus abdominis block group |
Primary outcome
The time to first analgesic request
Time frame: 24 hours postoperatively
The time to first analgesic request is recorded by a nurse unaware about the typy of block.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Individual participant dataSharing planned: Undecided. Authors haven't decided to make individual participant data (IPD) available to other researchers yet.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing propofol, Atracurium Besylate and sevoflurane in people with Quadratus Lumborum Block and Transversus Abdominis Plane Block, run by Tanta University.
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 2 inclusion and 5 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 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
The time to first analgesic request (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2022.