Sonographic Predictors of Difficult Epidural Placement.

Withdrawn

• Conditions: Epidural; Anesthesia, Headache; Anesthesia; Safety Issues
• Interventions: Other: Data collection

• Registration Number: NCT05893264
• Lead Sponsor: University of Padova

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-29
• Study First Submitted QC: 2023-05-29
• Study First Posted: 2023-06-07
• Study Start: 2023-08-14
• Primary Completion: 2023-08-14
• Study Completion: 2023-08-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

• Surgery with epidural placement
• Age > 18 years

Exclusion Criteria

• patient refusal

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Epidural placement	Data collection	All patients undergoing epidural placement will be enrolled.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
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
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
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
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
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
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
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

Trial Locations

Locations (1)

University Hospital of Padova; 🇮🇹 Padova, Veneto, Italy