Sonographic Predictors of Difficult Epidural Placement.

NCT05893264 | Withdrawn

• 1 other identifier: PREC-EPI
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Safety Issues; Epidural; Anesthesia, Headache

Keywords

technique; epidural; predictors; placement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

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

  through study completion, an average of 2 year

• Age (years) as predictive parameter for difficult epidural placement

  through study completion, an average of 2 year

• Height (cm) 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

  through study completion, an average of 2 year

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

  through study completion, an average of 2 year

Study Arms (1)

Epidural placement

All patients undergoing epidural placement will be enrolled.

Other: Data collection

Interventions

Data collection OTHER

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)

Epidural placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult patients undergoing surgery with epidural analgesia or anesthesia

You may qualify if:

• Surgery with epidural placement
• Age \> 18 years

You may not qualify if:

• patient refusal

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

University Hospital of Padova

Padua, Veneto, 35127, Italy

Location

MeSH Terms

Conditions

Headache

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 7, 2023
• Study Start: August 14, 2023
• Primary Completion: August 14, 2023
• Study Completion: August 14, 2023
• Last Updated: March 28, 2025

Record last verified: 2025-03

Locations

IT (1)