Sonographic Predictors of Difficult Epidural Placement.

Anesthesia Clinical Trial

— PREC-EPI  

Official title:

Sonographic Predictors of Difficult Epidural Placement.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05893264
• Other study ID #: PREC-EPI
• Status: Recruiting
• 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
• 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
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Surgery with epidural placement

• Age > 18 years

Exclusion Criteria:

• patient refusal

Related Conditions & MeSH terms

• Anesthesia
• Epidural; Anesthesia, Headache
• Headache
• Safety Issues

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