PREC-EPI: Sonographic Predictors of Difficult Epidural Placement.

Sponsor
University of Padova (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05893264
Collaborator
(none)
275
1
12
22.9

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Data collection

Study Design

Study Type:
Observational
Anticipated Enrollment :
275 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Sonographic Predictors of Difficult Epidural Placement.
Anticipated Study Start Date :
Jun 10, 2023
Anticipated Primary Completion Date :
Jun 10, 2024
Anticipated Study Completion Date :
Jun 10, 2024

Arms and Interventions

Arm Intervention/Treatment
Epidural placement

All patients undergoing epidural placement will be enrolled.

Other: Data collection
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)

Outcome Measures

Primary Outcome Measures

  1. Incidence of difficult epidural placement [through study completion, an average of 2 year]

    Described as the requirement to replace the needle by fully removing it from the skin.

Secondary Outcome Measures

  1. Total body weight (kg) as predictive parameter for difficult epidural placement [through study completion, an average of 2 year]

    Total body weight (kg) as predictive parameter for difficult epidural placement

  2. Age (years) as predictive parameter for difficult epidural placement [through study completion, an average of 2 year]

    Age (years) as predictive parameter for difficult epidural placement

  3. Height (cm) as predictive parameter for difficult epidural placement [through study completion, an average of 2 year]

    Height (cm) as predictive parameter for difficult epidural placement

  4. Palpable spinous process (well, not well, not palpable) as predictive parameter for difficult epidural placement [through study completion, an average of 2 year]

    Palpable spinous process (well, not well, not palpable) as predictive parameter for difficult epidural placement

  5. Previous spine surgery (yes, no) as predictive parameter for difficult epidural placement [through study completion, an average of 2 year]

    Previous spine surgery (yes, no) as predictive parameter for difficult epidural placement

  6. Anesthesiology experience (years) as predictive parameter for difficult epidural placement [through study completion, an average of 2 year]

    Anesthesiology experience (years) as predictive parameter for difficult epidural placement

  7. Sonographic skin to spinous process distance(cm) as predictive parameter for difficult epidural placement [through study completion, an average of 2 year]

    Sonographic skin to spinous process distance (cm) as predictive parameter for difficult epidural placement

  8. Sonographic spinous process to spinous process distance (cm)as predictive parameter for difficult epidural placement [through study completion, an average of 2 year]

    Sonographic spinous process to spinous process distance (cm)as predictive parameter for difficult epidural placement

  9. Sonographic skin to transverse process distance (cm) as predictive parameter for difficult epidural placement [through study completion, an average of 2 year]

    Sonographic skin to transverse process distance (cm) as predictive parameter for difficult epidural placement

  10. Sonographic erector spine muscle group size (cm) as predictive parameter for difficult epidural placement [through study completion, an average of 2 year]

    Sonographic erector spine muscle group size (cm) as predictive parameter for difficult epidural placement

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Surgery with epidural placement

  • Age > 18 years

Exclusion Criteria:
  • patient refusal

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital of Padova Padova Veneto Italy 35127

Sponsors and Collaborators

  • University of Padova

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alessandro De Cassai, Principal Investigator, University of Padova
ClinicalTrials.gov Identifier:
NCT05893264
Other Study ID Numbers:
  • PREC-EPI
First Posted:
Jun 7, 2023
Last Update Posted:
Jun 12, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alessandro De Cassai, Principal Investigator, University of Padova
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 12, 2023