AnesthesiaPREC-EPINCT05893264
Sonographic Predictors of Difficult Epidural Placement.
An observational study of Anesthesia and Safety Issues, run by University of Padova at 1 site in Italy.
Trial summary
Epidural placement is a commonly used procedure for pain management during labor, delivery, and surgeries. However, epidural placement is often considered a technically challenging and complex procedure that requires a high level of skill and experience. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Safety Issues, Epidural; Anesthesia, Headache
- What is being tested?
- Data collection
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 14 Aug 2023to 14 Aug 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients undergoing surgery with epidural analgesia or anesthesia
Who may be able to join
- Surgery with epidural placement
- Age > 18 years
Who cannot join
- patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Epidural placement is a commonly used procedure for pain management during labor, delivery, and surgeries. However, epidural placement is often considered a technically challenging and complex procedure that requires a high level of skill and experience. In cases where the epidural is improperly placed or fails to produce effective analgesia, the discomfort and distress experienced by the patient may be heightened. Hence, the use of predictors, such as sonographic ones, may prove to be a valuable tool for healthcare professionals in the placement of epidurals, ultimately ensuring successful pain management for patients.
The present study aims to identify predictors of difficult epidural placement in patients undergoing surgery.
- Conditions
- Anesthesia, Safety Issues, Epidural; Anesthesia, Headache
- Being tested
- Data collection
- Keywords
- technique, epidural, predictors, placement
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Several data will be collected such as:
Age, weight, height, gender, previous spine surgery, skoliosis (Y/N), palpable spinous process (Y/N), experience in years of anesthesiologist, spine level of epidural placement
and the following sonographic parameters at the level of epidural placement: skin-spinous process distance (cm), skin-transversous process distance (cm), erector spinae plane distance (cm), superior to inferior spinous process distance (cm)
| Study group | Role | What they receive |
|---|---|---|
| Epidural placement | All patients undergoing epidural placement will be enrolled. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of difficult epidural placement
Described as the requirement to replace the needle by fully removing it from the skin.
Measured: through study completion, an average of 2 year
Secondary outcomes (10)
Total body weight (kg) as predictive parameter for difficult epidural placement
Total body weight (kg) as predictive parameter for difficult epidural placement
Measured: through study completion, an average of 2 year
Age (years) as predictive parameter for difficult epidural placement
Age (years) as predictive parameter for difficult epidural placement
Measured: through study completion, an average of 2 year
Height (cm) as predictive parameter for difficult epidural placement
Height (cm) as predictive parameter for difficult epidural placement
Measured: through study completion, an average of 2 year
Palpable spinous process (well, not well, not palpable) as predictive parameter for difficult epidural placement
Palpable spinous process (well, not well, not palpable) as predictive parameter for difficult epidural placement
Measured: through study completion, an average of 2 year
Previous spine surgery (yes, no) as predictive parameter for difficult epidural placement
Previous spine surgery (yes, no) as predictive parameter for difficult epidural placement
Measured: through study completion, an average of 2 year
Anesthesiology experience (years) as predictive parameter for difficult epidural placement
Anesthesiology experience (years) as predictive parameter for difficult epidural placement
Measured: through study completion, an average of 2 year
Sonographic skin to spinous process distance(cm) as predictive parameter for difficult epidural placement
Sonographic skin to spinous process distance (cm) as predictive parameter for difficult epidural placement
Measured: through study completion, an average of 2 year
Sonographic spinous process to spinous process distance (cm)as predictive parameter for difficult epidural placement
Sonographic spinous process to spinous process distance (cm)as predictive parameter for difficult epidural placement
Measured: through study completion, an average of 2 year
Sonographic skin to transverse process distance (cm) as predictive parameter for difficult epidural placement
Sonographic skin to transverse process distance (cm) as predictive parameter for difficult epidural placement
Measured: through study completion, an average of 2 year
Sonographic erector spine muscle group size (cm) as predictive parameter for difficult epidural placement
Sonographic erector spine muscle group size (cm) as predictive parameter for difficult epidural placement
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start14 Aug 2023
- Primary completion14 Aug 2023
- Study completion14 Aug 2023
Why it stopped: Study has been withdrawn as after IRB approval PI changed his working institution making the conduction of the study unfeasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro De Cassai, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893264
- Sponsor's protocol ID
- PREC-EPI
- Acronym
- PREC-EPI
- Status last verified
- Mar 2025
- First submitted
- 29 May 2023
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data could be shared after ethical committee clearence and on a reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Predictors of Difficult Epidural Placement.
- ClinicalTrials.gov ID
- NCT05893264
- Acronym / sponsor ID
- PREC-EPI / PREC-EPI
- Conditions
- Anesthesia, Safety Issues, Epidural; Anesthesia, Headache
- Keywords
- technique, epidural, predictors, placement
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study has been withdrawn as after IRB approval PI changed his working institution making the conduction of the study unfeasible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 14 Aug 2023 (actual)
- First posted
- 7 Jun 2023 (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 placement is a commonly used procedure for pain management during labor, delivery, and surgeries. However, epidural placement is often considered a technically challenging and complex procedure that requires a high level of skill and experience. In cases where the epidural is improperly placed or fails to produce effective analgesia, the discomfort and distress experienced by the patient may be heightened. Hence, the use of predictors, such as sonographic ones, may prove to be a valuable tool for healthcare professionals in the placement of epidurals, ultimately ensuring successful pain management for patients.
The present study aims to identify predictors of difficult epidural placement in patients undergoing surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epidural placement | – | Other: Data collectionAll patients undergoing epidural placement will be enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients undergoing surgery with epidural analgesia or anesthesia
Key inclusion criteria (2 listed)
- Surgery with epidural placement
- Age > 18 years
Key exclusion criteria (1 listed)
- patient refusal
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 |
|---|---|---|
| Data collectionSeveral data will be collected such as: Age, weight, height, gender, previous spine surgery, skoliosis (Y/N), palpable spinous process (Y/N), experience in years of anesthesiologist, spine level of epidural placement and the following sonographic parameters at the level of epidural placement: skin-spinous process distance (cm), skin-transversous process distance (cm), erector spinae plane distance (cm), superior to inferior spinous process distance (cm) | Other | Epidural placement |
Primary outcome
Incidence of difficult epidural placement
Time frame: through study completion, an average of 2 year
Described as the requirement to replace the needle by fully removing it from the skin.
10 secondary outcomes
Total body weight (kg) as predictive parameter for difficult epidural placement
Time frame: through study completion, an average of 2 year
Age (years) as predictive parameter for difficult epidural placement
Time frame: through study completion, an average of 2 year
Height (cm) as predictive parameter for difficult epidural placement
Time frame: through study completion, an average of 2 year
Palpable spinous process (well, not well, not palpable) as predictive parameter for difficult epidural placement
Time frame: through study completion, an average of 2 year
Previous spine surgery (yes, no) as predictive parameter for difficult epidural placement
Time frame: through study completion, an average of 2 year
Anesthesiology experience (years) as predictive parameter for difficult epidural placement
Time frame: through study completion, an average of 2 year
Sonographic skin to spinous process distance(cm) as predictive parameter for difficult epidural placement
Time frame: through study completion, an average of 2 year
Sonographic spinous process to spinous process distance (cm)as predictive parameter for difficult epidural placement
Time frame: through study completion, an average of 2 year
Sonographic skin to transverse process distance (cm) as predictive parameter for difficult epidural placement
Time frame: through study completion, an average of 2 year
Sonographic erector spine muscle group size (cm) as predictive parameter for difficult epidural placement
Time frame: through study completion, an average of 2 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: Undecided. Data could be shared after ethical committee clearence and on a reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Safety Issues, run by University of Padova 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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 28 Mar 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Incidence of difficult epidural placement (time frame: through study completion, an average of 2 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 Mar 2025.