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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05893264
Other study ID # PREC-EPI
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 14, 2023
Est. completion date June 10, 2024

Study information

Verified date August 2023
Source University of Padova
Contact Alessandro De Cassai, MD
Phone +390498213090
Email alessandro.decassai@aopd.veneto.it
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 275
Est. completion date June 10, 2024
Est. primary completion date June 10, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Surgery with epidural placement - Age > 18 years Exclusion Criteria: - patient refusal

Study Design


Intervention

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)

Locations

Country Name City State
Italy University Hospital of Padova Padova Veneto

Sponsors (1)

Lead Sponsor Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of difficult epidural placement Described as the requirement to replace the needle by fully removing it from the skin. through study completion, an average of 2 year
Secondary Total body weight (kg) as predictive parameter for difficult epidural placement Total body weight (kg) as predictive parameter for difficult epidural placement through study completion, an average of 2 year
Secondary Age (years) as predictive parameter for difficult epidural placement Age (years) as predictive parameter for difficult epidural placement through study completion, an average of 2 year
Secondary Height (cm) as predictive parameter for difficult epidural placement Height (cm) as predictive parameter for difficult epidural placement through study completion, an average of 2 year
Secondary 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 through study completion, an average of 2 year
Secondary Previous spine surgery (yes, no) as predictive parameter for difficult epidural placement Previous spine surgery (yes, no) as predictive parameter for difficult epidural placement through study completion, an average of 2 year
Secondary Anesthesiology experience (years) as predictive parameter for difficult epidural placement Anesthesiology experience (years) as predictive parameter for difficult epidural placement through study completion, an average of 2 year
Secondary 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 through study completion, an average of 2 year
Secondary 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 through study completion, an average of 2 year
Secondary 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 through study completion, an average of 2 year
Secondary 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 through study completion, an average of 2 year
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