PregnancyOST-22-01NCT06811649
Comparison of Echo-assisted ALR Technique and Traditional ALR Technique for the Placement of an Epidural Catheter in the Obstetric Patient
A study testing Ultrasound guided injection with local anaestethic in people with Pregnancy, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
This is a randomized, open-label, single-center clinical trial. The purpose of the study is to understand whether the aid of ultrasound assessment is useful in improving the competence of resident. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Ultrasound guided injection with local anaestethic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteItaly
- Study dates
- 17 Jul 2023to 31 Jul 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant patients >18 years of age with no BMI (Body Mass Index) limitation
- Pregnant patients requiring partoanalgesia
- Obtaining informed consent for study participation
Who cannot join
- Patients with contraindications to epidural catheter placement
- Endocranial hypertension
- Coagulopathies
- Severe thrombocytopenia < 75,000 per mm^3.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aurora Guglielmetti, MD contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
About this study
Official title: Comparison of Echo-assisted ALR (Loco-regional Anesthesia) Technique and Traditional ALR Technique for the Placement of an Epidural Catheter in the Obstetric Patient Performed by an Anesthesia Resident
This is a randomized, open-label, single-center clinical trial. The purpose of the study is to understand whether the aid of ultrasound assessment is useful in improving the competence of resident.
Specifically, to demonstrate how the aid of echo-assistance in the evaluation of the spine increases the atraumatic success rate (primary objective) and reduces the number of complications (particularly, the number of attempts needed and the rate of dura puncture) (secondary objective) in physicians in specialty training.
Pregnant patients requiring peridural analgesia will be assigned to the intervention or control group by simple randomization.
Read the detailed description
The use of echo-assisted assessment has been studied for about a decade, showing encouraging results as far as experienced medical personnel are concerned, but to date, a systematic study assessing the usefulness of this aid in improving residents' competence (as indicated by the 2019 systematic review) is lacking in the literature.
To date, echo-assisted assessment is not routinely applied to all obstetric patients, as it is a relatively new technique and not yet widely used by all anesthesiologists.
If the results of the study are positive,echo-assisted assessment use could be expanded, reducing the number of complications and increasing the number of atraumatic epidural catheter placements.
- Conditions
- Pregnancy
- Being tested
- Ultrasound guided injection with local anaestethic
- Keywords
- epidural catheter, loco-regional anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided injection with local anaestethicDiagnostic test
Experimental treatment consists of ultrasound assessment combined with palpatory assessment to identify the most suitable space for epidural catheter insertion.
The conventional neuroaxial technique relies on palpation of the spinous processes and iliac crests to recognize the midline and height of the lumbar interspace to be used to perform a neuroaxial block.
With the echo-assisted technique, in aid of the conventional technique, a preprocedure (Prepuncture) is performed for the purpose of combining classic anatomical findings with useful sonographic findings that should improve the success of the neuroaxial technique.
| Study group | Role | What they receive |
|---|---|---|
| echo-assisted ALR (loco-regional anesthesia) technique | Experimental | Ultrasound evaluation of the spine as an aid in facilitating the placement of an epidural catheter Receives: Diagnostic Test: Ultrasound guided injection with local anaestethic |
| traditional ALR technique | No intervention | The traditional neuroaxial technique involves palpation of the spinous processes and iliac crests to recognize the median and height of the lumbar interspace to be used to perform a neuroaxial block |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of FNP (thus atraumatic puncture)
The primary objective of this study is to demonstrate whether or not the aid of echo-assistance in spinal evaluation, performed by an experienced anesthesiologist, increases the atraumatic success rate, First Needle Pass (FNP), in epidural catheter placement by inexperienced personnel (physicians in specialty training, MFS).
This objective will be calculated by observing the rate of FNP (thus atraumatic puncture).
Measured: Through study completion,an average of 1 year
Secondary outcomes (1)
Change the number of complications
The secondary objective is to demonstrate whether the aid of echo-assistance in the evaluation of the spine, performed by an experienced anesthesiologist, reduces the number of complications (particularly the number of attempts needed and the rate of dura puncture, (accidental dural puncture, ADP) in epidural catheter placement by inexperienced personnel (physicians in specialty training).
The following outcomes will be considered to assess this objective:
- number of traumatic punctures defined as: presence of redirects or number of punctures greater than one
- median number of multiple punctures
- number of women with failure (defined as number of punctures > 3)
- number of accidental dural punctures (detected as CSF leaks).
Measured: Through study completion,an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start17 Jul 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurora Guglielmetti, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811649
- Sponsor's protocol ID
- OST-22-01
- Acronym
- OST-22-01
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Echo-assisted ALR (Loco-regional Anesthesia) Technique and Traditional ALR Technique for the Placement of an Epidural Catheter in the Obstetric Patient Performed by an Anesthesia Resident
- ClinicalTrials.gov ID
- NCT06811649
- Acronym / sponsor ID
- OST-22-01 / OST-22-01
- Conditions
- Pregnancy
- Keywords
- epidural catheter, loco-regional anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 6 Feb 2025 (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.
This is a randomized, open-label, single-center clinical trial. The purpose of the study is to understand whether the aid of ultrasound assessment is useful in improving the competence of resident.
Specifically, to demonstrate how the aid of echo-assistance in the evaluation of the spine increases the atraumatic success rate (primary objective) and reduces the number of complications (particularly, the number of attempts needed and the rate of dura puncture) (secondary objective) in physicians in specialty training.
Pregnant patients requiring peridural analgesia will be assigned to the intervention or control group by simple randomization.
Detailed description
The use of echo-assisted assessment has been studied for about a decade, showing encouraging results as far as experienced medical personnel are concerned, but to date, a systematic study assessing the usefulness of this aid in improving residents' competence (as indicated by the 2019 systematic review) is lacking in the literature.
To date, echo-assisted assessment is not routinely applied to all obstetric patients, as it is a relatively new technique and not yet widely used by all anesthesiologists.
If the results of the study are positive,echo-assisted assessment use could be expanded, reducing the number of complications and increasing the number of atraumatic epidural catheter placements.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| echo-assisted ALR (loco-regional anesthesia) technique | Experimental | Diagnostic Test: Ultrasound guided injection with local anaestethicUltrasound evaluation of the spine as an aid in facilitating the placement of an epidural catheter |
| traditional ALR technique | No intervention | –The traditional neuroaxial technique involves palpation of the spinous processes and iliac crests to recognize the median and height of the lumbar interspace to be used to perform a neuroaxial block |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant patients >18 years of age with no BMI (Body Mass Index) limitation
- Pregnant patients requiring partoanalgesia
- Obtaining informed consent for study participation
Key exclusion criteria (4 listed)
- Patients with contraindications to epidural catheter placement
- Endocranial hypertension
- Coagulopathies
- Severe thrombocytopenia < 75,000 per mm^3.
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 |
|---|---|---|
| Ultrasound guided injection with local anaestethicExperimental treatment consists of ultrasound assessment combined with palpatory assessment to identify the most suitable space for epidural catheter insertion. The conventional neuroaxial technique relies on palpation of the spinous processes and iliac crests to recognize the midline and height of the lumbar interspace to be used to perform a neuroaxial block. With the echo-assisted technique, in aid of the conventional technique, a preprocedure (Prepuncture) is performed for the purpose of combining classic anatomical findings with useful sonographic findings that should improve the success of the neuroaxial technique. | Diagnostic test | echo-assisted ALR (loco-regional anesthesia) technique |
Primary outcome
the rate of FNP (thus atraumatic puncture)
Time frame: Through study completion,an average of 1 year
The primary objective of this study is to demonstrate whether or not the aid of echo-assistance in spinal evaluation, performed by an experienced anesthesiologist, increases the atraumatic success rate, First Needle Pass (FNP), in epidural catheter placement by inexperienced personnel (physicians in specialty training, MFS). This objective will be calculated by observing the rate of FNP (thus atraumatic puncture).
1 secondary outcome
Change the number of complications
Time frame: Through study completion,an average of 1 year
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 28 Oct 2026.
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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.
Aurora Guglielmetti, MD contact
Aurora Guglielmetti, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided injection with local anaestethic in people with Pregnancy, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 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: looking for participants now, as of the sponsor's last update on 28 Oct 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 Italy. 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?
Contact Aurora Guglielmetti, MD (0039 05121414378, aurora.guglielmetti@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of FNP (thus atraumatic puncture) (time frame: Through study completion,an average of 1 year). 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 28 Oct 2026.