Epidural Catheter Location by Epidural Pressure Waveform

Completed

• Conditions: Anesthesia, Local

• Registration Number: NCT04205773
• Lead Sponsor: European e-Learning School in Obstetric Anesthesia

Brief Summary

The aim of this preliminary study was to evaluate the new CompuFlo instrument which allows pulsatile waveform recordings.

Detailed Description

30 epidural catheters previously successfully used for obstetric anesthesia or analgesia and about to be removed were tested. All patients were given 5 mL 2% lidocaine to test the catheter before its removal. After priming with 5 mL saline, the catheter was connected to CompuFlo to record the occurrence of pulsatile waveforms and/or their disappearance during its removal. The epidural catheter was marked at the skin level to record the distance between the skin at the time of measurements. The power analysis required a sample of 30 observations to set 80% test power and 95% significance level.

Study Timeline

• Study Start: 2019-11-01
• Primary Completion: 2019-11-29
• Study Completion: 2019-11-30
• Status Verified: 2019-12
• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2019-12-18
• Study First Posted: 2019-12-19
• Last Update Submitted: 2019-12-19
• Last Update Posted: 2019-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Obstetric patients
• Must have an epidural catheter

Exclusion criteria

• Non-obstetric patients

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pulsatile waveforms observation (presence or absence)	30 minutes	The epidural catheter was considered to be in the epidural space if the appearance of pulsatile waveforms were observed, and confirmed by the occurrence of L2-3 sensory block after the test dose. The disappearance of the pulsatile waveforms when the catheter was extracted from the epidural space was also noted.

Trial Locations

Locations (2)

Città di Roma Hospital; 🇮🇹 Rome, Italy

EESOA Maternal Neonatal Simulation Centre; 🇮🇹 Roma, Italy