Ultrasound-guided Neuraxial ProceduresNCT04985279
Position and Angle Marking System (PAMS) for Ultrasound-guided Neuraxial Procedures
A study testing Position and Angle Marking System and Standard clinical practice in people with Ultrasound-guided Neuraxial Procedures, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
Epidural anaesthesia involves the administration of numbing medication (local anaesthetics) close to the spinal canal, and is regarded as the best method for providing pain relief during labour and childbirth. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ultrasound-guided Neuraxial Procedures
- What is being tested?
- Position and Angle Marking System and Standard clinical practice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- 7 Sep 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Anaesthesiologists
- Trained in the use of ultrasound-guided neuraxial procedures
- Healthy, no significant medical comorbidity (American Society of Anesthesiologists Physical Status I or II)
- No spinal abnormalities, or previous spinal surgery
Who cannot join
- No experience with ultrasound-guided neuraxial procedures
- Simulated patients
- Significant spinal abnormality
- Previous spinal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Epidural anaesthesia involves the administration of numbing medication (local anaesthetics) close to the spinal canal, and is regarded as the best method for providing pain relief during labour and childbirth. The use of ultrasound to guide epidural insertion and placement has been shown to improve pain relief and reduce the risk of complications.
However, after identifying the desired needle insertion site via ultrasound, current practice involves demarcating the insertion site using marker pens, which is time-consuming, inaccurate, and may be inadvertently removed by skin sterilisation. Furthermore, the desired needle angulation determined by ultrasound cannot be accurately measured and maintained during the epidural procedure. Both issues limit the benefits of using ultrasound to guide the epidural procedure.
Read more
To address these issues, the investigators developed a Position and Angular Marking System (PAMS) that attaches on to the ultrasound probe. When the desired insertion site is identified by ultrasound, the doctor gently presses PAMS into the patient's back to create skin indentations demarcating the needle insertion point. These indentations are not affected by skin sterilisation, and may improve accuracy and reduce the time taken to perform the epidural procedure. Next, the angle between the ultrasound probe and the patient's back can be measured using PAMS, and this angle can be maintained using a needle guide during the epidural procedure.
The purpose of this randomised study is to evaluate the usability of PAMS and to identify areas for further improvement.
This study will involve up to 10 healthy simulated patients, and up to 30 volunteer ultrasound operators. After undergoing a standardised training session with a mannequin, the ultrasound operators will be randomly assigned to perform skin marking on the simulated patients as though they are performing an ultrasound-guided epidural anaesthesia procedure (no needle puncture will be made) using either PAMS, or standard clinical practice with marker pens. After completing the procedure, the ultrasound operators will cross over and perform the procedure again using either PAMS or standard clinical practice with marker pens.
Both the ultrasound operators and simulated patients will be asked to complete satisfaction and usability surveys regarding their experience with the procedures.
Read the detailed description
The volunteer ultrasound operators are women's anaesthesiologists trained in the use of ultrasound-guided neuraxial procedures.
Simulated patients are healthy volunteers from other departments, without spine abnormalities.
The ultrasound operators will be asked to complete a questionnaire regarding your prior experience with neuraxial ultrasonography and undergo structured training on the use of PAMS using a mannequin. Next, they will be asked to perform the following two procedures (the order at which they will perform the procedures will be randomised):
- Ultrasound scan using PAMS
- After attaching PAMS to the ultrasound probe, they will perform a lumbar ultrasound scan on a simulated patient to identify the desired needle insertion site and gently press PAMS into the simulated patient's back to create skin indentations demarcating the desired needle insertion site.
- Next, adjust the angulation of the ultrasound probe to optimise the image of the simulated patient's lumbar spine, and read the angle between the ultrasound probe and patient's back off a graduated scale.
- Remove the ultrasound probe, and position the needle-insertion guide corresponding to the skin indentations. Needle angulation can be simulated by mounting a blunt needle on to the insertion guide.
- Finally, they will be asked to complete a usability questionnaire.
- Ultrasound scan without PAMS (standard clinical practice)
- Perform a lumbar ultrasound scan to identify the desired needle insertion site, followed by demarcation using skin markers.
- Next, adjust the angulation of the ultrasound probe to optimise the image of the simulated patient's lumbar spine.
- Remove the ultrasound probe and simulate needle insertion by touching the tip of a blunt needle to the patient's back, at the desired angle.
- Finally, they will then be asked to complete a usability questionnaire.
Both procedures are non-invasive (i.e. no skin punctures will be made). No follow up is required for this study.
No new research medications are involved in this study.
Additionally, video recordings may be made of the procedures. Any video or ultrasound images obtained during the course of this study will be stored and analysed only for the purposes of this study for a period not exceeding 7 years, and will be destroyed after completion of the study. Technical data such as the scanning duration and success rate will also be documented.
- Conditions
- Ultrasound-guided Neuraxial Procedures
- Being tested
- Position and Angle Marking System, Standard clinical practice
- Keywords
- Ultrasonography, Epidural, Spinal, Labour analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Position and Angle Marking SystemDevice
Also called PAMS
Position and Angular Marking System (PAMS) attaches on to the ultrasound probe. When the desired insertion site is identified by ultrasound, the doctor gently presses PAMS into the patient's back to create skin indentations demarcating the needle insertion point. These indentations are not affected by skin sterilisation, and may improve accuracy and reduce the time taken to perform the epidural procedure. Next, the angle between the ultrasound probe and the patient's back can be measured using PAMS, and this angle can be maintained using a needle guide during the epidural procedure.
Standard clinical practiceDevice
When the desired insertion site is identified by ultrasound, the doctor demarcate the needle insertion point using marker pens.
| Study group | Role | What they receive |
|---|---|---|
| Standard clinical practice | Active comparator | * Lumbar ultrasound scan will be performed to identify the desired needle insertion site, followed by demarcation using skin markers.
* The angulation of the ultrasound probe will be adjusted to optimise the image of the simulated patient's lumbar spine.
* The ultrasound probe will be removed and needle insertion simulated by touching the tip of a blunt needle to the patient's back, at the desired angle.
* A usability questionnaire regarding the procedure will be completed. Receives: Device: Standard clinical practice |
| Position and Angle Marking System (PAMS) | Experimental | * PAMS will be attached to the ultrasound probe.
* Lumbar ultrasound scan will be performed to identify the desired needle insertion site, followed by demarcation by gentle pressing PAMS into the simulated patient's back to create skin indentations.
* The angulation of the ultrasound probe will be adjusted to optimise the image of the simulated patient's lumbar spine, and the angle read off a graduated scale.
* The ultrasound probe will be removed and needle insertion simulated by touching the tip of a blunt needle to the patient's back, at the desired angle.
* A usability questionnaire regarding the procedure will be completed. Receives: Device: Position and Angle Marking System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction survey of simulated patients and operators
Satisfaction and feedback regarding the respective procedures
Measured: Immediately after performing the procedure
Secondary outcomes (1)
Time taken to perform procedure
Comparison of time taken to perform the interventional procedure (PAMS), versus standard clinical practice (control)
Measured: Immediately after performing the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start7 Sep 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ultrasound-guided Neuraxial ProceduresStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The ultrasound operators will be randomised to perform either 1. Skin marking after lumbar ultrasonography using marker pens (standard practice) 2. Skin marking after lumbar ultrasonography using PAMS After completion of the first procedure, the ultrasound operators will then crossover and perform the other procedure.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sng Ban Leong, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985279
- Sponsor's protocol ID
- PAMS 2021/2159
- Status last verified
- Aug 2026
- First submitted
- 5 Jul 2021
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tan HS, Sng BL, Sia ATH. Reducing breakthrough pain during labour epidural analgesia: an update. Curr Opin Anaesthesiol. 2019 Jun;32(3):307-314. doi: 10.1097/ACO.0000000000000713.
PubMed 31045638
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Position and Angle Marking System (PAMS) for Ultrasound-guided Neuraxial Procedures
- ClinicalTrials.gov ID
- NCT04985279
- Acronym / sponsor ID
- PAMS 2021/2159
- Conditions
- Ultrasound-guided Neuraxial Procedures
- Keywords
- Ultrasonography, Epidural, Spinal, Labour analgesia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Aug 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.
Epidural anaesthesia involves the administration of numbing medication (local anaesthetics) close to the spinal canal, and is regarded as the best method for providing pain relief during labour and childbirth. The use of ultrasound to guide epidural insertion and placement has been shown to improve pain relief and reduce the risk of complications.
However, after identifying the desired needle insertion site via ultrasound, current practice involves demarcating the insertion site using marker pens, which is time-consuming, inaccurate, and may be inadvertently removed by skin sterilisation. Furthermore, the desired needle angulation determined by ultrasound cannot be accurately measured and maintained during the epidural procedure. Both issues limit the benefits of using ultrasound to guide the epidural procedure.
To address these issues, the investigators developed a Position and Angular Marking System (PAMS) that attaches on to the ultrasound probe. When the desired insertion site is identified by ultrasound, the doctor gently presses PAMS into the patient's back to create skin indentations demarcating the needle insertion point. These indentations are not affected by skin sterilisation, and may improve accuracy and reduce the time taken to perform the epidural procedure. Next, the angle between the ultrasound probe and the patient's back can be measured using PAMS, and this angle can be maintained using a needle guide during the epidural procedure.
The purpose of this randomised study is to evaluate the usability of PAMS and to identify areas for further improvement.
This study will involve up to 10 healthy simulated patients, and up to 30 volunteer ultrasound operators. After undergoing a standardised training session with a mannequin, the ultrasound operators will be randomly assigned to perform skin marking on the simulated patients as though they are performing an ultrasound-guided epidural anaesthesia procedure (no needle puncture will be made) using either PAMS, or standard clinical practice with marker pens. After completing the procedure, the ultrasound operators will cross over and perform the procedure again using either PAMS or standard clinical practice with marker pens.
Both the ultrasound operators and simulated patients will be asked to complete satisfaction and usability surveys regarding their experience with the procedures.
Detailed description
The volunteer ultrasound operators are women's anaesthesiologists trained in the use of ultrasound-guided neuraxial procedures.
Simulated patients are healthy volunteers from other departments, without spine abnormalities.
The ultrasound operators will be asked to complete a questionnaire regarding your prior experience with neuraxial ultrasonography and undergo structured training on the use of PAMS using a mannequin. Next, they will be asked to perform the following two procedures (the order at which they will perform the procedures will be randomised):
- Ultrasound scan using PAMS
- After attaching PAMS to the ultrasound probe, they will perform a lumbar ultrasound scan on a simulated patient to identify the desired needle insertion site and gently press PAMS into the simulated patient's back to create skin indentations demarcating the desired needle insertion site.
- Next, adjust the angulation of the ultrasound probe to optimise the image of the simulated patient's lumbar spine, and read the angle between the ultrasound probe and patient's back off a graduated scale.
- Remove the ultrasound probe, and position the needle-insertion guide corresponding to the skin indentations. Needle angulation can be simulated by mounting a blunt needle on to the insertion guide.
- Finally, they will be asked to complete a usability questionnaire.
- Ultrasound scan without PAMS (standard clinical practice)
- Perform a lumbar ultrasound scan to identify the desired needle insertion site, followed by demarcation using skin markers.
- Next, adjust the angulation of the ultrasound probe to optimise the image of the simulated patient's lumbar spine.
- Remove the ultrasound probe and simulate needle insertion by touching the tip of a blunt needle to the patient's back, at the desired angle.
- Finally, they will then be asked to complete a usability questionnaire.
Both procedures are non-invasive (i.e. no skin punctures will be made). No follow up is required for this study.
No new research medications are involved in this study.
Additionally, video recordings may be made of the procedures. Any video or ultrasound images obtained during the course of this study will be stored and analysed only for the purposes of this study for a period not exceeding 7 years, and will be destroyed after completion of the study. Technical data such as the scanning duration and success rate will also be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The ultrasound operators will be randomised to perform either 1. Skin marking after lumbar ultrasonography using marker pens (standard practice) 2. Skin marking after lumbar ultrasonography using PAMS After completion of the first procedure, the ultrasound operators will then crossover and perform the other procedure.
| Arm | Type | Receives |
|---|---|---|
| Standard clinical practice | Active comparator | Device: Standard clinical practice* Lumbar ultrasound scan will be performed to identify the desired needle insertion site, followed by demarcation using skin markers. * The angulation of the ultrasound probe will be adjusted to optimise the image of the simulated patient's lumbar spine. * The ultrasound probe will be removed and needle insertion simulated by touching the tip of a blunt needle to the patient's back, at the desired angle. * A usability questionnaire regarding the procedure will be completed. |
| Position and Angle Marking System (PAMS) | Experimental | Device: Position and Angle Marking System* PAMS will be attached to the ultrasound probe. * Lumbar ultrasound scan will be performed to identify the desired needle insertion site, followed by demarcation by gentle pressing PAMS into the simulated patient's back to create skin indentations. * The angulation of the ultrasound probe will be adjusted to optimise the image of the simulated patient's lumbar spine, and the angle read off a graduated scale. * The ultrasound probe will be removed and needle insertion simulated by touching the tip of a blunt needle to the patient's back, at the desired angle. * A usability questionnaire regarding the procedure will be completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Anaesthesiologists
- Trained in the use of ultrasound-guided neuraxial procedures
- Healthy, no significant medical comorbidity (American Society of Anesthesiologists Physical Status I or II)
- No spinal abnormalities, or previous spinal surgery
Key exclusion criteria (4 listed)
- No experience with ultrasound-guided neuraxial procedures
- Simulated patients
- Significant spinal abnormality
- Previous spinal surgery
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 |
|---|---|---|
| Position and Angle Marking SystemAlso: PAMSPosition and Angular Marking System (PAMS) attaches on to the ultrasound probe. When the desired insertion site is identified by ultrasound, the doctor gently presses PAMS into the patient's back to create skin indentations demarcating the needle insertion point. These indentations are not affected by skin sterilisation, and may improve accuracy and reduce the time taken to perform the epidural procedure. Next, the angle between the ultrasound probe and the patient's back can be measured using PAMS, and this angle can be maintained using a needle guide during the epidural procedure. | Device | Position and Angle Marking System (PAMS) |
| Standard clinical practiceWhen the desired insertion site is identified by ultrasound, the doctor demarcate the needle insertion point using marker pens. | Device | Standard clinical practice |
Primary outcome
Satisfaction survey of simulated patients and operators
Time frame: Immediately after performing the procedure
Satisfaction and feedback regarding the respective procedures
1 secondary outcome
Time taken to perform procedure
Time frame: Immediately after performing the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Background: PubMed 31045638Tan HS, Sng BL, Sia ATH. Reducing breakthrough pain during labour epidural analgesia: an update. Curr Opin Anaesthesiol. 2019 Jun;32(3):307-314. doi: 10.1097/ACO.0000000000000713.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Position and Angle Marking System and Standard clinical practice in people with Ultrasound-guided Neuraxial Procedures, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. 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 Singapore. 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?
This study is still under way. Results are not available in the source record yet.
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?
Satisfaction survey of simulated patients and operators (time frame: Immediately after performing the procedure). 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 NCT04985279, which also lists 1 linked publication.
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 2026.