Surgical Procedure, UnspecifiedNCT03603574
Epidural Waveform Analysis for Thoracic Epidural Blocks
A study testing EWA through the needle and EWA through the catheter in people with Surgical Procedure, Unspecified, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in 2 countries.
Trial summary
Epidural waveform analysis (EWA) provides a simple confirmatory adjunct for loss-of-resistance (LOR): when the needle/catheter tip is correctly positioned inside the epidural space, pressure measurement results in a pulsatile waveform. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- EWA through the needle and EWA through the catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Jul 2018to 2 Feb 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 18 and 80 years
- American Society of Anesthesiologists classification 1-3
- body mass index between 20 and 35
Who cannot join
- adults who are unable to give their own consent
- coagulopathy
- renal failure
- hepatic failure
- allergy to local anesthetic
- pregnancy
- prior surgery in the thoracic spine
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomized Comparison Between Epidural Waveform Analysis Through the Needle Versus the Catheter for Thoracic Epidural Blocks
Epidural waveform analysis (EWA) provides a simple confirmatory adjunct for loss-of-resistance (LOR): when the needle/catheter tip is correctly positioned inside the epidural space, pressure measurement results in a pulsatile waveform. Epidural waveform analysis can be carried out through the tip of the needle or the catheter. In this randomized trial, the objective is to compare epidural waveform analysis through the needle (EWA-N) and through the catheter (EWA-C) for thoracic epidural blocks.
Read the detailed description
The epidural space is most commonly identified with loss-of-resistance (LOR). Though sensitive Epidural waveform analysis (EWA) provides a simple confirmatory adjunct for LOR. When the needle (or catheter) is correctly positioned inside the epidural space, pressure measurement at its tip results in a pulsatile waveform synchronized with arterial pulsations Currently, there exist two different methods for EWA. Since local anesthetic (LA) is administered through the catheter, pressure transduction through its tip ensures that it is properly positioned inside the epidural space prior to LA injection. Alternately, EWA can be performed through the needle prior to blind advancement of the epidural catheter.
Thus, in this randomized trial, the aim is to compare epidural waveform analysis through the needle (EWA-N) and through the catheter (EWA-C) for thoracic epidural blocks. The hypothesis is that, compared to EWA-C, EWA-N will result in a shorter performance time.
- Conditions
- Surgical Procedure, Unspecified
- Being tested
- EWA through the needle, EWA through the catheter
- Keywords
- Abdomen/surgery, Thoracic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EWA through the needleDevice
In the EWA-N group, 5 mL of normal saline are injected through the epidural needle after the occurrence of loss-of-resistance (LOR). The needle is connected to the pressure transducer. A satisfactory endpoint is defined as the presence of waveforms synchronized with arterial pulsations. In the absence of pulsatile waveforms, the operator injects an additional 2.5 mL-bolus of normal saline through the epidural needle and reconnects the latter to the pressure transducer. If no waveforms are detected after the second injection, the operator removes the needle and reattempts the epidural block at a different intervertebral level. A maximum of 3 levels is permitted: if waveforms are still absent at the third level, the operator simply accepts LOR as the technical endpoint.
EWA through the catheterDevice
In the EWA-C group, the epidural catheter is advanced 5 cm beyond the needle tip after the occurrence of LOR. Subsequently, the operator injects 5 mL of normal saline through the catheter and the latter is connected to the pressure transducer via the sterile, rigid extension tubing. A satisfactory endpoint is defined as the presence of waveforms. In the absence of pulsatile waveforms, the operator injects an additional 2.5 mL-bolus of saline through the catheter and reconnects the latter to the pressure transducer. If no waveforms are detected after the second injection are still absent at the third level, the operator simply accepts this position for catheter placement (intent-to-treat analysis).
| Study group | Role | What they receive |
|---|---|---|
| EWA through the needle | Experimental | EWA through the needle group, 5 mL of normal saline are injected through the epidural needle after the occurrence of LOR. The needle is subsequently connected to the pressure transducer (leveled with the heart) via the sterile, rigid extension tubing. A satisfactory endpoint is defined as the presence of waveforms synchronized with arterial pulsations. Receives: Device: EWA through the needle |
| EWA through the catheter | Experimental | EWA through the catheter group, the epidural catheter is advanced 5 cm beyond the needle tip after the occurrence of LOR. Subsequently, the operator injects 5 mL of normal saline through the catheter and the latter is connected to the pressure transducer via the sterile, rigid extension tubing. A satisfactory endpoint is defined as the presence of waveforms synchronized with arterial pulsations. Receives: Device: EWA through the catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance time of block
temporal interval in minutes between skin infiltration and local anesthetic administration through the epidural catheter (after obtaining a satisfactory waveform either through the needle or through the catheter depending on randomized group assignment).
Measured: From skin infiltration until local anesthetic administration through the needle or catheter, up to 60 minutes
Secondary outcomes (6)
Incidence of successful epidural block
bilateral block to ice in at least 2 dermatomes
Measured: 15 minutes after the administration of local anesthetic through the epidural catheter
Procedural pain during epidural block assessed by the numeric rating scale
pain in the back of the patient, related to the performance of the epidural block, using a numeric rating scale from 0 to 10 points (0=no pain and 10= worst imaginable pain)
Measured: From the performance of the epidural block until induction of general anesthesia, up to 2 hours
Postoperative pain related to surgical incision assessed by the numeric rating scale
pain at rest and upon deep breathing/coughing, measured using a numeric rating scale from 0 to 10 points ((0=no pain and 10= worst imaginable pain)
Measured: twice a day from the arrival at PACU or until catheter removal, up to 5 days
Local anesthetic consumption
amount of local anesthetic consumed
Measured: once a day from the arrival at PACU or until catheter removal, up to 5 days
Breakthrough opioid consumption (if required)
amount of opioids consumed
Measured: once a day from the arrival at PACU or until catheter removal, up to 5 days
Incidence of adverse events
side effects related to the performance of the epidural block (eg, dural/vascular puncture, paresthesia) or breakthrough opioids (nausea, vomiting, pruritus, somnolence, respiratory depression)
Measured: Once a day from catheter insertion until removal, up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start30 Jul 2018
- Primary completion30 Jan 2019
- Study completion2 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- 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
- Randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Ramathibodi Hospital, University of Chile
- Responsible party
- Principal investigator, De Tran, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- De Q Tran, MD, FRCPC, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603574
- Sponsor's protocol ID
- 2019-4669
- Status last verified
- Feb 2019
- First submitted
- 25 Jun 2018
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tran DQ, Gonzalez AP, Bernucci F, Finlayson RJ. Confirmation of loss-of-resistance for epidural analgesia. Reg Anesth Pain Med. 2015 Mar-Apr;40(2):166-73. doi: 10.1097/AAP.0000000000000217. No abstract available.
PubMed 25642911Sharrock NE. Recordings of, and an anatomical explanation for, false positive loss of resistance during lumbar extradural analgesia. Br J Anaesth. 1979 Mar;51(3):253-8. doi: 10.1093/bja/51.3.253.
PubMed 435350BONICA J. Continuous peridural block. Anesthesiology. 1956 Jul-Aug;17(4):626-30. No abstract available.
PubMed 13327296Lirk P, Kolbitsch C, Putz G, Colvin J, Colvin HP, Lorenz I, Keller C, Kirchmair L, Rieder J, Moriggl B. Cervical and high thoracic ligamentum flavum frequently fails to fuse in the midline. Anesthesiology. 2003 Dec;99(6):1387-90. doi: 10.1097/00000542-200312000-00023.
PubMed 14639154Lirk P, Moriggl B, Colvin J, Keller C, Kirchmair L, Rieder J, Kolbitsch C. The incidence of lumbar ligamentum flavum midline gaps. Anesth Analg. 2004 Apr;98(4):1178-1180. doi: 10.1213/01.ANE.0000101486.41355.35.
PubMed 15041621Chayen D, Nathan H, Chayen M. The psoas compartment block. Anesthesiology. 1976 Jul;45(1):95-9. doi: 10.1097/00000542-197607000-00019. No abstract available.
PubMed 937760Eason MJ, Wyatt R. Paravertebral thoracic block-a reappraisal. Anaesthesia. 1979 Jul-Aug;34(7):638-42. doi: 10.1111/j.1365-2044.1979.tb06363.x.
PubMed 517716Leurcharusmee P, Arnuntasupakul V, Chora De La Garza D, Vijitpavan A, Ah-Kye S, Saelao A, Tiyaprasertkul W, Finlayson RJ, Tran DQ. Reliability of Waveform Analysis as an Adjunct to Loss of Resistance for Thoracic Epidural Blocks. Reg Anesth Pain Med. 2015 Nov-Dec;40(6):694-7. doi: 10.1097/AAP.0000000000000313.
PubMed 26469364Tran DQ, Van Zundert TC, Aliste J, Engsusophon P, Finlayson RJ. Primary Failure of Thoracic Epidural Analgesia in Training Centers: The Invisible Elephant? Reg Anesth Pain Med. 2016 May-Jun;41(3):309-13. doi: 10.1097/AAP.0000000000000394.
PubMed 27035462Arnuntasupakul V, Van Zundert TC, Vijitpavan A, Aliste J, Engsusophon P, Leurcharusmee P, Ah-Kye S, Finlayson RJ, Tran DQ. A Randomized Comparison Between Conventional and Waveform-Confirmed Loss of Resistance for Thoracic Epidural Blocks. Reg Anesth Pain Med. 2016 May-Jun;41(3):368-73. doi: 10.1097/AAP.0000000000000369.
PubMed 26894628de Medicis E, Tetrault JP, Martin R, Robichaud R, Laroche L. A prospective comparative study of two indirect methods for confirming the localization of an epidural catheter for postoperative analgesia. Anesth Analg. 2005 Dec;101(6):1830-1833. doi: 10.1213/01.ANE.0000184130.73634.BE.
PubMed 16301268de Medicis E, Pelletier J, Martin R, Loignon MJ, Tetrault JP, Laroche L. Technical report: optimal quantity of saline for epidural pressure waveform analysis. Can J Anaesth. 2007 Oct;54(10):818-21. doi: 10.1007/BF03021709.
PubMed 17934163Tangjitbampenbun A, Layera S, Arnuntasupakul V, Apinyachon W, Venegas K, Godoy J, Aliste J, Bravo D, Blanch A, Webar J, Saadawi M, Owen A, Finlayson RJ, Tran DQ. Randomized comparison between epidural waveform analysis through the needle versus the catheter for thoracic epidural blocks. Reg Anesth Pain Med. 2019 May 14:rapm-2019-100478. doi: 10.1136/rapm-2019-100478. Online ahead of print.
PubMed 31092706
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison Between Epidural Waveform Analysis Through the Needle Versus the Catheter for Thoracic Epidural Blocks
- ClinicalTrials.gov ID
- NCT03603574
- Acronym / sponsor ID
- 2019-4669
- Conditions
- Surgical Procedure, Unspecified
- Keywords
- Abdomen/surgery, Thoracic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Ramathibodi Hospital, University of Chile
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 2 Feb 2019 (actual)
- First posted
- 27 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Epidural waveform analysis (EWA) provides a simple confirmatory adjunct for loss-of-resistance (LOR): when the needle/catheter tip is correctly positioned inside the epidural space, pressure measurement results in a pulsatile waveform. Epidural waveform analysis can be carried out through the tip of the needle or the catheter. In this randomized trial, the objective is to compare epidural waveform analysis through the needle (EWA-N) and through the catheter (EWA-C) for thoracic epidural blocks.
Detailed description
The epidural space is most commonly identified with loss-of-resistance (LOR). Though sensitive Epidural waveform analysis (EWA) provides a simple confirmatory adjunct for LOR. When the needle (or catheter) is correctly positioned inside the epidural space, pressure measurement at its tip results in a pulsatile waveform synchronized with arterial pulsations Currently, there exist two different methods for EWA. Since local anesthetic (LA) is administered through the catheter, pressure transduction through its tip ensures that it is properly positioned inside the epidural space prior to LA injection. Alternately, EWA can be performed through the needle prior to blind advancement of the epidural catheter.
Thus, in this randomized trial, the aim is to compare epidural waveform analysis through the needle (EWA-N) and through the catheter (EWA-C) for thoracic epidural blocks. The hypothesis is that, compared to EWA-C, EWA-N will result in a shorter performance time.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized trial
| Arm | Type | Receives |
|---|---|---|
| EWA through the needle | Experimental | Device: EWA through the needleEWA through the needle group, 5 mL of normal saline are injected through the epidural needle after the occurrence of LOR. The needle is subsequently connected to the pressure transducer (leveled with the heart) via the sterile, rigid extension tubing. A satisfactory endpoint is defined as the presence of waveforms synchronized with arterial pulsations. |
| EWA through the catheter | Experimental | Device: EWA through the catheterEWA through the catheter group, the epidural catheter is advanced 5 cm beyond the needle tip after the occurrence of LOR. Subsequently, the operator injects 5 mL of normal saline through the catheter and the latter is connected to the pressure transducer via the sterile, rigid extension tubing. A satisfactory endpoint is defined as the presence of waveforms synchronized with arterial pulsations. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 18 and 80 years
- American Society of Anesthesiologists classification 1-3
- body mass index between 20 and 35
Key exclusion criteria (7 listed)
- adults who are unable to give their own consent
- coagulopathy
- renal failure
- hepatic failure
- allergy to local anesthetic
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 |
|---|---|---|
| EWA through the needleIn the EWA-N group, 5 mL of normal saline are injected through the epidural needle after the occurrence of loss-of-resistance (LOR). The needle is connected to the pressure transducer. A satisfactory endpoint is defined as the presence of waveforms synchronized with arterial pulsations. In the absence of pulsatile waveforms, the operator injects an additional 2.5 mL-bolus of normal saline through the epidural needle and reconnects the latter to the pressure transducer. If no waveforms are detected after the second injection, the operator removes the needle and reattempts the epidural block at a different intervertebral level. A maximum of 3 levels is permitted: if waveforms are still absent at the third level, the operator simply accepts LOR as the technical endpoint. | Device | EWA through the needle |
| EWA through the catheterIn the EWA-C group, the epidural catheter is advanced 5 cm beyond the needle tip after the occurrence of LOR. Subsequently, the operator injects 5 mL of normal saline through the catheter and the latter is connected to the pressure transducer via the sterile, rigid extension tubing. A satisfactory endpoint is defined as the presence of waveforms. In the absence of pulsatile waveforms, the operator injects an additional 2.5 mL-bolus of saline through the catheter and reconnects the latter to the pressure transducer. If no waveforms are detected after the second injection are still absent at the third level, the operator simply accepts this position for catheter placement (intent-to-treat analysis). | Device | EWA through the catheter |
Primary outcome
Performance time of block
Time frame: From skin infiltration until local anesthetic administration through the needle or catheter, up to 60 minutes
temporal interval in minutes between skin infiltration and local anesthetic administration through the epidural catheter (after obtaining a satisfactory waveform either through the needle or through the catheter depending on randomized group assignment).
6 secondary outcomes
Incidence of successful epidural block
Time frame: 15 minutes after the administration of local anesthetic through the epidural catheter
Procedural pain during epidural block assessed by the numeric rating scale
Time frame: From the performance of the epidural block until induction of general anesthesia, up to 2 hours
Postoperative pain related to surgical incision assessed by the numeric rating scale
Time frame: twice a day from the arrival at PACU or until catheter removal, up to 5 days
Local anesthetic consumption
Time frame: once a day from the arrival at PACU or until catheter removal, up to 5 days
Breakthrough opioid consumption (if required)
Time frame: once a day from the arrival at PACU or until catheter removal, up to 5 days
Incidence of adverse events
Time frame: Once a day from catheter insertion until removal, up to 5 days
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 6 Feb 2019.
- Background: PubMed 25642911Tran DQ, Gonzalez AP, Bernucci F, Finlayson RJ. Confirmation of loss-of-resistance for epidural analgesia. Reg Anesth Pain Med. 2015 Mar-Apr;40(2):166-73. doi: 10.1097/AAP.0000000000000217. No abstract available.
- Background: PubMed 435350Sharrock NE. Recordings of, and an anatomical explanation for, false positive loss of resistance during lumbar extradural analgesia. Br J Anaesth. 1979 Mar;51(3):253-8. doi: 10.1093/bja/51.3.253.
- Background: PubMed 13327296BONICA J. Continuous peridural block. Anesthesiology. 1956 Jul-Aug;17(4):626-30. No abstract available.
- Background: PubMed 14639154Lirk P, Kolbitsch C, Putz G, Colvin J, Colvin HP, Lorenz I, Keller C, Kirchmair L, Rieder J, Moriggl B. Cervical and high thoracic ligamentum flavum frequently fails to fuse in the midline. Anesthesiology. 2003 Dec;99(6):1387-90. doi: 10.1097/00000542-200312000-00023.
- Background: PubMed 15041621Lirk P, Moriggl B, Colvin J, Keller C, Kirchmair L, Rieder J, Kolbitsch C. The incidence of lumbar ligamentum flavum midline gaps. Anesth Analg. 2004 Apr;98(4):1178-1180. doi: 10.1213/01.ANE.0000101486.41355.35.
- Background: PubMed 937760Chayen D, Nathan H, Chayen M. The psoas compartment block. Anesthesiology. 1976 Jul;45(1):95-9. doi: 10.1097/00000542-197607000-00019. No abstract available.
- Background: PubMed 517716Eason MJ, Wyatt R. Paravertebral thoracic block-a reappraisal. Anaesthesia. 1979 Jul-Aug;34(7):638-42. doi: 10.1111/j.1365-2044.1979.tb06363.x.
- Background: PubMed 26469364Leurcharusmee P, Arnuntasupakul V, Chora De La Garza D, Vijitpavan A, Ah-Kye S, Saelao A, Tiyaprasertkul W, Finlayson RJ, Tran DQ. Reliability of Waveform Analysis as an Adjunct to Loss of Resistance for Thoracic Epidural Blocks. Reg Anesth Pain Med. 2015 Nov-Dec;40(6):694-7. doi: 10.1097/AAP.0000000000000313.
- Background: PubMed 27035462Tran DQ, Van Zundert TC, Aliste J, Engsusophon P, Finlayson RJ. Primary Failure of Thoracic Epidural Analgesia in Training Centers: The Invisible Elephant? Reg Anesth Pain Med. 2016 May-Jun;41(3):309-13. doi: 10.1097/AAP.0000000000000394.
- Background: PubMed 26894628Arnuntasupakul V, Van Zundert TC, Vijitpavan A, Aliste J, Engsusophon P, Leurcharusmee P, Ah-Kye S, Finlayson RJ, Tran DQ. A Randomized Comparison Between Conventional and Waveform-Confirmed Loss of Resistance for Thoracic Epidural Blocks. Reg Anesth Pain Med. 2016 May-Jun;41(3):368-73. doi: 10.1097/AAP.0000000000000369.
- Background: PubMed 16301268de Medicis E, Tetrault JP, Martin R, Robichaud R, Laroche L. A prospective comparative study of two indirect methods for confirming the localization of an epidural catheter for postoperative analgesia. Anesth Analg. 2005 Dec;101(6):1830-1833. doi: 10.1213/01.ANE.0000184130.73634.BE.
- Background: PubMed 17934163de Medicis E, Pelletier J, Martin R, Loignon MJ, Tetrault JP, Laroche L. Technical report: optimal quantity of saline for epidural pressure waveform analysis. Can J Anaesth. 2007 Oct;54(10):818-21. doi: 10.1007/BF03021709.
- 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.
De Q Tran, MD, FRCPC principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EWA through the needle and EWA through the catheter in people with Surgical Procedure, Unspecified, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in 2 countries.
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 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 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile, Thailand. 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?
Performance time of block (time frame: From skin infiltration until local anesthetic administration through the needle or catheter, up to 60 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 NCT03603574, which also lists 13 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 6 Feb 2019.