Anesthesia, LocalNCT04782778
Comparison of Supraclavicular and Costoclavicular Brachial Plexus Blocks in Pediatrics
A study testing Bupivacaine 0.25% Injectable Solution in people with Anesthesia, Local and Postoperative Pain, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
In upper extremity surgeries, the brachial plexus block can be performed with different techniques at various levels depending on the proximal and distal level of the surgery. As an alternative to the infraclavicular brachial plexus block, which has been used for many years and which we routinely perform to every… Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local, Postoperative Pain
- What is being tested?
- Bupivacaine 0.25% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Undergoing unilateral upper extremity surgery (distal midhumerus).
- ASA(American Society of Anesthesiology) 1-3
- Receiving family consent from the parents that they accept regional analgesia
Who cannot join
- Parents refusal
- Infection on the local anesthetic application area
- Infection in the central nervous system
- Coagulopathy
- Brain tumors
- Known allergy against local anesthetics
- Anatomical difficulties
- Syndromic patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Ultrasound-Guided Supraclavicular and Costoclavicular Brachial Plexus Blocks in Pediatric Patients Undergoing Unilateral Upper Exremity Surgery: A Randomized Controlled Double-Blinded Study
In upper extremity surgeries, the brachial plexus block can be performed with different techniques at various levels depending on the proximal and distal level of the surgery.
As an alternative to the infraclavicular brachial plexus block, which has been used for many years and which we routinely perform to every pediatric patient under general anesthesia; Costoclavicular block is recommended due to its advantages such as short application time, single injection and sufficient ultrasound imaging, and its use is becoming widespread. There are studies comparing these two methods. However in this study, we aim to compare the postoperative analgesic effects of US-guided costoclavicular technique with US-guided supraclavicular technique, which is more common for many years and is performed 2-3 cm proximal to the costoclavicular block area.
Read more
During the block application, the US imaging time, the difficulty level of needle imaging, the number of maneuvers required to reach the target image, whether additional maneuvers are required according to the local anesthetic distribution, the success of the block and the duration of the surgery, the total application time of the block and the duration of general anesthesia will be recorded. Mean arterial pressure and heart rate will be recorded at 30-minute intervals during the surgery. Standardized for pediatric patients The FLACC and Wong-Baker pain scores will be followed first 24 hours after surgery. The patient will be examined for pain, motor and sensation, and analgesic doses will be recorded if used. Time to first pain identification, duration of sleep, patient and surgeon satisfaction will be recorded.
The rarely onset of hemidiaphragmatic paralysis during supraclavicular block reduces its use. Costoclavicular block could be a safe and effective alternative. One of our seconder objectives is to assess the incidence of hemidiaphragmatic paralysis following ultrasound-guided supraclavicular block and compare it to that of costoclavicular block. For this purpose diaphragmatic excursion is visualized by M-mode ultrasonography 30 minutes after extubation. In B-mode, the diaphragm thickness measurement at the end of expiratory and inspiratory end is recorded and the diaphragm thickness fraction is calculated. Absence of diaphragmatic excursion during a sniff test or sighing defined the hemidiaphragmatic paralysis.
Read the detailed description
Peripheral nerve blocks; It is widely used in daily practice for anesthesia or as a part of multimodal analgesia in most surgical procedures. In upper extremity surgeries, the brachial plexus block can be performed with different techniques at various levels depending on the proximal and distal level of the surgery. In this study, the aim is to compare postoperative analgesic effects of these two ultrasound-guided techniques in pediatric patients.
As an alternative to the infraclavicular brachial plexus block, which has been used for many years and which we routinely perform to every pediatric patient under general anesthesia; Costoclavicular block is recommended due to its advantages such as short application time, single injection and sufficient ultrasound imaging, and its use is becoming widespread. There are studies comparing these two methods. However, we aim to compare the costoclavicular technique with the supraclavicular technique, which is more common for many years and is performed 2-3 cm proximal to the costoclavicular block area. Thus demonstrate the safety of upper extremity blocks, which is an important part of multimodal analgesia, and to determine the most ideal technique in the pediatric patient group who will undergo upper extremity surgery.
During the block application, the US imaging time, the difficulty level of needle imaging, the number of maneuvers required to reach the target image, whether additional maneuvers are required according to the local anesthetic distribution, the success of the block and the duration of the surgery, the total application time of the block and the duration of general anesthesia will be recorded. Mean arterial pressure and heart rate will be recorded at 30-minute intervals during the surgery. Standardized for pediatric patients The FLACC and Wong-Baker pain scores will be followed first 24 hours after surgery. The patient will be examined for pain, motor and sensation, and analgesic doses will be recorded if used. Time to first pain identification, duration of sleep, patient and surgeon satisfaction will be recorded.
The rarely onset of hemidiaphragmatic paralysis during supraclavicular block reduces its use. Costoclavicular block could be a safe and effective alternative. One of our seconder objectives is to assess the incidence of hemidiaphragmatic paralysis following ultrasound-guided supraclavicular block and compare it to that of costoclavicular block. For this purpose diaphragmatic excursion is visualized by M-mode ultrasonography 30 minutes after extubation. In B-mode, the diaphragm thickness measurement at the end of expiratory and inspiratory end is recorded and the diaphragm thickness fraction is calculated. Absence of diaphragmatic excursion during a sniff test or sighing defined the hemidiaphragmatic paralysis.
- Conditions
- Anesthesia, Local, Postoperative Pain
- Being tested
- Bupivacaine 0.25% Injectable Solution
- Keywords
- Postoperative Analgesia, Upper Extremity Surgery, Supraclavicular Block, Costoclavicular Block, Brachial Plexus Block, Ultrasound Guidance
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.25% Injectable SolutionDrug
Also called Marcaine
1 mg/kg Bupivacaine (0.25%)
| Study group | Role | What they receive |
|---|---|---|
| Costoclavicular Block | Active comparator | US-guided lateral approach costoclavicular block with 1 mg/kg Bupivacaine (%0,25) Receives: Drug: Bupivacaine 0.25% Injectable Solution |
| Ultrasound Guided Supraclavicular Block | Active comparator | US-guided supraclavicular block with 1 mg/kg Bupivacaine (%0,25) Receives: Drug: Bupivacaine 0.25% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total block application time
Total block application time from the needle's entrance to the exit from the skin
Measured: Up to 15 minutes
Secondary outcomes (16)
Ideal USG guided brachial plexus cords visualization/needle pathway planning time
Practitioner's ideal image acquisition time
Measured: Up to 15 minutes
Needle tip and shaft imaging visualization
Likert scale: 1-5 (1:very hard 5:very easy)
Measured: Up to 15 minutes
Number of needle maneuvers
Number of needle maneuvers according to local anesthetic distribution
Measured: Up to 15 minutes
Total procedure difficulty according to the anesthesiologist
Likert Scale: 1-5 (1:very hard 5:very easy)
Measured: Up to 15 minutes
Patient number requiring rescue analgesics
If a ≥ 20% increase above preinduction values in MAP or HR was observed during the perioperative period, additional fentanyl dose (1 μg/kg) was applied intravenously.
Measured: Intraoperative 2-4 hours
Face, Legs Activity, Cry, Consolability (FLACC) scores
It corporates five categories of behavior, each scored on 0-2 point scale so that total score ranges from 0 to 10. Total scores of 0-3 is defined as mild or no pain, 4-7 as moderate, and 8-10 as severe pain.
Measured: Up to 24 hours
Wong Baker FACES scale
The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable"
Measured: Up to 24 hours
Motor blockade physical examination
Each nerve scored on 0-2 point scale so that total score ranges from 0 to 8. Total scores of 0 point is defined as absent motor blockade (full movement); 1 point as partial blockade (able to free movement only) or 2 point as complete blockade (unable to move). (Separately for these four nerves; N. Medianus, N. ulnaris, N. radialis and N. musculocutaneous).
Measured: Up to 24 hours
Sensorial blockade physical examination
Each nerve scored on 0-2 point scale with pinprick test so that total score ranges from 0 to 8. Total scores of 0 point is defined as absent sensorial blockade (feels pain), 1 point as partial blockade (feels touch) or 2 point as complete blockade (no sense). (Separately for these four nerves; N. Medianus, N. ulnaris, N. radialis and N. musculocutaneous).
Measured: Up to 24 hours
Complications/side effects
Vascular puncture, hematoma, pleura puncture, infections, phrenic nerve paralysis
Measured: Up to first week
Incidence of symptomatic/asymptomatic postprocedural phrenic nerve paralysis
Diaphragmatic excursion is visualized by M-mode ultrasonography 30 minutes after extubation. In B-mode, the diaphragm thickness measurement at the end of expiratory and end of inspiratory is recorded and the diaphragm thickness fraction is calculated.
Measured: Up to 2 hours
Time to postoperative first pain
Time to first analgesic
Measured: Up to 24 hours
Patient number who require additional analgesic
Number of patients who require IV morphine (0.03 mg/kg) and paracetamol
Measured: Up to 24 hours
Duration of sleep
Total hours of sleep first day
Measured: Up to 24 hours
Family satisfaction
Satisfaction score: 0: very unsatisfied, 3: very satisfied
Measured: Up to 24 hours
Surgeon satisfaction
Satisfaction score: 0: very unsatisfied, 3: very satisfied
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Apr 2021
- Primary completion1 May 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RANDOMISED DOUBLE BLINDED INTERVENTIONAL
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Savran Karadeniz, Istanbul University
- Investigators
- Meltem Savran Karadeniz, Assoc.Prof., Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782778
- Sponsor's protocol ID
- 2020/46
- Status last verified
- Jul 2022
- First submitted
- 2 Mar 2021
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Songthamwat B, Karmakar MK, Li JW, Samy W, Mok LYH. Ultrasound-Guided Infraclavicular Brachial Plexus Block: Prospective Randomized Comparison of the Lateral Sagittal and Costoclavicular Approach. Reg Anesth Pain Med. 2018 Nov;43(8):825-831. doi: 10.1097/AAP.0000000000000822.
PubMed 29923950Grape S, Pawa A, Weber E, Albrecht E. Retroclavicular vs supraclavicular brachial plexus block for distal upper limb surgery: a randomised, controlled, single-blinded trial. Br J Anaesth. 2019 Apr;122(4):518-524. doi: 10.1016/j.bja.2018.12.022. Epub 2019 Jan 31.
PubMed 30857608Sivashanmugam T, Maurya I, Kumar N, Karmakar MK. Ipsilateral hemidiaphragmatic paresis after a supraclavicular and costoclavicular brachial plexus block: A randomised observer blinded study. Eur J Anaesthesiol. 2019 Oct;36(10):787-795. doi: 10.1097/EJA.0000000000001069.
PubMed 31397702Luo Q, Yao W, Chai Y, Chang L, Yao H, Liang J, Hao N, Guo S, Shu H. Comparison of ultrasound-guided supraclavicular and costoclavicular brachial plexus block using a modified double-injection technique: a randomized non-inferiority trial. Biosci Rep. 2020 Jun 26;40(6):BSR20200084. doi: 10.1042/BSR20200084.
PubMed 32441302
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-Guided Supraclavicular and Costoclavicular Brachial Plexus Blocks in Pediatric Patients Undergoing Unilateral Upper Exremity Surgery: A Randomized Controlled Double-Blinded Study
- ClinicalTrials.gov ID
- NCT04782778
- Acronym / sponsor ID
- 2020/46
- Conditions
- Anesthesia, Local, Postoperative Pain
- Keywords
- Postoperative Analgesia, Upper Extremity Surgery, Supraclavicular Block, Costoclavicular Block, Brachial Plexus Block, Ultrasound Guidance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In upper extremity surgeries, the brachial plexus block can be performed with different techniques at various levels depending on the proximal and distal level of the surgery.
As an alternative to the infraclavicular brachial plexus block, which has been used for many years and which we routinely perform to every pediatric patient under general anesthesia; Costoclavicular block is recommended due to its advantages such as short application time, single injection and sufficient ultrasound imaging, and its use is becoming widespread. There are studies comparing these two methods. However in this study, we aim to compare the postoperative analgesic effects of US-guided costoclavicular technique with US-guided supraclavicular technique, which is more common for many years and is performed 2-3 cm proximal to the costoclavicular block area.
During the block application, the US imaging time, the difficulty level of needle imaging, the number of maneuvers required to reach the target image, whether additional maneuvers are required according to the local anesthetic distribution, the success of the block and the duration of the surgery, the total application time of the block and the duration of general anesthesia will be recorded. Mean arterial pressure and heart rate will be recorded at 30-minute intervals during the surgery. Standardized for pediatric patients The FLACC and Wong-Baker pain scores will be followed first 24 hours after surgery. The patient will be examined for pain, motor and sensation, and analgesic doses will be recorded if used. Time to first pain identification, duration of sleep, patient and surgeon satisfaction will be recorded.
The rarely onset of hemidiaphragmatic paralysis during supraclavicular block reduces its use. Costoclavicular block could be a safe and effective alternative. One of our seconder objectives is to assess the incidence of hemidiaphragmatic paralysis following ultrasound-guided supraclavicular block and compare it to that of costoclavicular block. For this purpose diaphragmatic excursion is visualized by M-mode ultrasonography 30 minutes after extubation. In B-mode, the diaphragm thickness measurement at the end of expiratory and inspiratory end is recorded and the diaphragm thickness fraction is calculated. Absence of diaphragmatic excursion during a sniff test or sighing defined the hemidiaphragmatic paralysis.
Detailed description
Peripheral nerve blocks; It is widely used in daily practice for anesthesia or as a part of multimodal analgesia in most surgical procedures. In upper extremity surgeries, the brachial plexus block can be performed with different techniques at various levels depending on the proximal and distal level of the surgery. In this study, the aim is to compare postoperative analgesic effects of these two ultrasound-guided techniques in pediatric patients.
As an alternative to the infraclavicular brachial plexus block, which has been used for many years and which we routinely perform to every pediatric patient under general anesthesia; Costoclavicular block is recommended due to its advantages such as short application time, single injection and sufficient ultrasound imaging, and its use is becoming widespread. There are studies comparing these two methods. However, we aim to compare the costoclavicular technique with the supraclavicular technique, which is more common for many years and is performed 2-3 cm proximal to the costoclavicular block area. Thus demonstrate the safety of upper extremity blocks, which is an important part of multimodal analgesia, and to determine the most ideal technique in the pediatric patient group who will undergo upper extremity surgery.
During the block application, the US imaging time, the difficulty level of needle imaging, the number of maneuvers required to reach the target image, whether additional maneuvers are required according to the local anesthetic distribution, the success of the block and the duration of the surgery, the total application time of the block and the duration of general anesthesia will be recorded. Mean arterial pressure and heart rate will be recorded at 30-minute intervals during the surgery. Standardized for pediatric patients The FLACC and Wong-Baker pain scores will be followed first 24 hours after surgery. The patient will be examined for pain, motor and sensation, and analgesic doses will be recorded if used. Time to first pain identification, duration of sleep, patient and surgeon satisfaction will be recorded.
The rarely onset of hemidiaphragmatic paralysis during supraclavicular block reduces its use. Costoclavicular block could be a safe and effective alternative. One of our seconder objectives is to assess the incidence of hemidiaphragmatic paralysis following ultrasound-guided supraclavicular block and compare it to that of costoclavicular block. For this purpose diaphragmatic excursion is visualized by M-mode ultrasonography 30 minutes after extubation. In B-mode, the diaphragm thickness measurement at the end of expiratory and inspiratory end is recorded and the diaphragm thickness fraction is calculated. Absence of diaphragmatic excursion during a sniff test or sighing defined the hemidiaphragmatic paralysis.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- RANDOMISED DOUBLE BLINDED INTERVENTIONAL
| Arm | Type | Receives |
|---|---|---|
| Costoclavicular Block | Active comparator | Drug: Bupivacaine 0.25% Injectable SolutionUS-guided lateral approach costoclavicular block with 1 mg/kg Bupivacaine (%0,25) |
| Ultrasound Guided Supraclavicular Block | Active comparator | Drug: Bupivacaine 0.25% Injectable SolutionUS-guided supraclavicular block with 1 mg/kg Bupivacaine (%0,25) |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Undergoing unilateral upper extremity surgery (distal midhumerus).
- ASA(American Society of Anesthesiology) 1-3
- Receiving family consent from the parents that they accept regional analgesia
Key exclusion criteria (8 listed)
- Parents refusal
- Infection on the local anesthetic application area
- Infection in the central nervous system
- Coagulopathy
- Brain tumors
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 |
|---|---|---|
| Bupivacaine 0.25% Injectable SolutionAlso: Marcaine1 mg/kg Bupivacaine (0.25%) | Drug | Costoclavicular Block, Ultrasound Guided Supraclavicular Block |
Primary outcome
Total block application time
Time frame: Up to 15 minutes
Total block application time from the needle's entrance to the exit from the skin
16 secondary outcomes
Ideal USG guided brachial plexus cords visualization/needle pathway planning time
Time frame: Up to 15 minutes
Needle tip and shaft imaging visualization
Time frame: Up to 15 minutes
Number of needle maneuvers
Time frame: Up to 15 minutes
Total procedure difficulty according to the anesthesiologist
Time frame: Up to 15 minutes
Patient number requiring rescue analgesics
Time frame: Intraoperative 2-4 hours
Face, Legs Activity, Cry, Consolability (FLACC) scores
Time frame: Up to 24 hours
Wong Baker FACES scale
Time frame: Up to 24 hours
Motor blockade physical examination
Time frame: Up to 24 hours
Sensorial blockade physical examination
Time frame: Up to 24 hours
Complications/side effects
Time frame: Up to first week
Incidence of symptomatic/asymptomatic postprocedural phrenic nerve paralysis
Time frame: Up to 2 hours
Time to postoperative first pain
Time frame: Up to 24 hours
Patient number who require additional analgesic
Time frame: Up to 24 hours
Duration of sleep
Time frame: Up to 24 hours
Family satisfaction
Time frame: Up to 24 hours
Surgeon satisfaction
Time frame: Up to 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 1 Aug 2022.
- Background: PubMed 29923950Songthamwat B, Karmakar MK, Li JW, Samy W, Mok LYH. Ultrasound-Guided Infraclavicular Brachial Plexus Block: Prospective Randomized Comparison of the Lateral Sagittal and Costoclavicular Approach. Reg Anesth Pain Med. 2018 Nov;43(8):825-831. doi: 10.1097/AAP.0000000000000822.
- Background: PubMed 30857608Grape S, Pawa A, Weber E, Albrecht E. Retroclavicular vs supraclavicular brachial plexus block for distal upper limb surgery: a randomised, controlled, single-blinded trial. Br J Anaesth. 2019 Apr;122(4):518-524. doi: 10.1016/j.bja.2018.12.022. Epub 2019 Jan 31.
- Background: PubMed 31397702Sivashanmugam T, Maurya I, Kumar N, Karmakar MK. Ipsilateral hemidiaphragmatic paresis after a supraclavicular and costoclavicular brachial plexus block: A randomised observer blinded study. Eur J Anaesthesiol. 2019 Oct;36(10):787-795. doi: 10.1097/EJA.0000000000001069.
- Background: PubMed 32441302Luo Q, Yao W, Chai Y, Chang L, Yao H, Liang J, Hao N, Guo S, Shu H. Comparison of ultrasound-guided supraclavicular and costoclavicular brachial plexus block using a modified double-injection technique: a randomized non-inferiority trial. Biosci Rep. 2020 Jun 26;40(6):BSR20200084. doi: 10.1042/BSR20200084.
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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.
Meltem Savran Karadeniz, Assoc.Prof. principal investigator
Istanbul 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 Bupivacaine 0.25% Injectable Solution in people with Anesthesia, Local and Postoperative Pain, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 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 1 Aug 2022. 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 Turkey (Türkiye). 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?
Total block application time (time frame: Up to 15 minutes). 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 NCT04782778, which also lists 4 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 1 Aug 2022.