Sonographic Predictors of Difficult Epidural Placement. (PREC-EPI)

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia; Safety Issues; Epidural; Anesthesia, Headache
• Intervention / Treatment: Other: Data collection

• Study Type: Observational
• Enrollment (Estimated): 275

Contacts and Locations

• Study Contact: Name: Alessandro De Cassai, MD; Phone Number: +390498213090; Email: alessandro.decassai@aopd.veneto.it

Study Locations

• Italy
  • Veneto
    • Padova, Veneto, Italy, 35127
      • Recruiting
      • University Hospital of Padova
      • Contact: Alessandro De Cassai, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

All adult patients undergoing surgery with epidural analgesia or anesthesia

Description

Inclusion Criteria:

• Surgery with epidural placement
• Age > 18 years

Exclusion Criteria:

• patient refusal

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Padova

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2023
• Primary Completion (Estimated): June 10, 2024
• Study Completion (Estimated): June 10, 2024

Study Registration Dates

• First Submitted: May 29, 2023
• First Submitted That Met QC Criteria: May 29, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: predictors; epidural; technique; placement
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache
• Other Study ID Numbers: PREC-EPI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data could be shared after ethical committee clearence and on a reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No