Epidural Computer Controlled System for the Epidural Space Verification

Identification of the Epidural Space: a Double Blind Comparison Between th CompuFlo® Epidural Computer Controlled System and the Standard LOR to Saline Technique in Obstetrics

The purpose of this study will be to evaluate the inter-rater agreement, or concordance, between an expert anaesthesiologist and the CompuFlo® Epidural Computer Controlled System for the epidural space verification.

Primary study endpoint will be successful concordance of identification of ligamentum flavum and epidural space during a standard epidural procedure in pregnant patient. Secondary outcome will be successful concordance of identification of bony contact during a standard epidural procedure in pregnant patient.

Study Overview

• Status: Completed
• Conditions: Epidural

Detailed Description

After skin local anesthesia and after the subcutaneous insertion of the epidural Tuohy needle, an independent investigator will make the O point of the CompuFlo® device that will be connected, via a three way stopcock, to the Tuohy needle in order to register, in a double blind way, the delta of pressures encountered by the needle during its advancement.

When the operator will reach the supraspinous ligament, a slight resistance will be encountered due to the nature of the bevel, and the density of the ligament. As soon as this resistance will be felt, the operator immediately will tell the investigator who will flag the CompuFlo® device. If no sensation will be felt the operator will tell "none" to the investigator.

The needle will be then advanced through the loose interspinous ligament which typically offers much less resistance than the sopraspinous ligament (often felt as a "no resistance feeling" in the obstetric patient). Once again, as soon as this loss or reduced or no resistance sensation is felt, the operator immediately will tell the investigator who will flag the CompuFlo® device. If no sensation will be felt the operator will tell "none" to the investigator.

According to the standard epidural technique, the point of the needle will be further advanced. The feeling of a greater increase of resistance, often associated with a "crunch", usually indicates the initial penetration of the needle in the rear wall of the ligamentum flavum. As soon as this resistance or "crunch" is felt, the operator immediately will tell the investigator who will flag the CompuFlo® device.

Then, the operator will remove the stylet and gently will attach to the needle a disposable 10 mL loss of resistance syringe containing a few millimeters (5-7 mL) of sterile saline solution and will open the three way stopcock in order to record both the pressures given-and-received by the CompuFlo® and the pressure produced by the operator's hand.

Constant, unremitting pressure will be now exerted on the plunger of the syringe by the thumb of the dominant hand of the operator in order to obtain the needle advancement solely by means of the pressure exerted by the operator on the plunger of the syringe.

As the point of the needle will emerge from the ligamentum flavum into the epidural space, the resistance suddenly will disappear and the advancement of the needle immediately will stop, (since the driving force exerted on the piston is discharged by the sudden entering of the liquid in the epidural space). As soon as this loss of resistance is felt, the operator immediately will tell the investigator who will who will flag the CompuFlo® device. The operator will stop the procedure for at least 10 seconds to allow the investigator to record the static epidural pressures.

• Study Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Healthy parturients

Description

Inclusion Criteria:

• Parturients undergoing epidural block for cesarean section or labor analgesia

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

anesthesiologist; The active comparators for this study will be expert anaesthesiologists (operator). The operators will be blinded to all visual and audible CompuFlo® real-time pressure feedbacks.Inter-rater agreement, or concordance, between an expert anaesthesiologist and the CompuFlo® Epidural Computer Controlled System for the epidural space verification will be assessed by blinded tagging of the operator's feeling of the ligamenta and epidural space on the screen of the Compuflo to be eventually compared with the pressure's variations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
concordance between anesthesiologist and Compuflo	Primary study endpoint will be successful concordance of identification of ligamentum flavum and epidural space during a standard epidural procedure in pregnant patient.	during epidural technique performance

Collaborators and Investigators

• Sponsor: Città di Roma Hospital
• Investigators: Principal Investigator: Giorgio Capogna, Citta di Roma Hospital

Publications and helpful links

General Publications

• Ghelber O, Gebhard RE, Vora S, Hagberg CA, Szmuk P. Identification of the epidural space using pressure measurement with the compuflo injection pump--a pilot study. Reg Anesth Pain Med. 2008 Jul-Aug;33(4):346-52. doi: 10.1016/j.rapm.2008.01.012.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2017
• Primary Completion (Actual): May 16, 2017
• Study Completion (Actual): May 20, 2017

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): May 24, 2017
• Last Update Submitted That Met QC Criteria: May 23, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Epidural technique
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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