Epidural Computer Controlled System for the Epidural Space Verification

Epidural Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03165708
• Other study ID #: 001
• Status: Completed
• Phase: N/A
• First received: May 22, 2017
• Last updated: May 23, 2017
• Start date: January 2, 2017
• Est. completion date: May 20, 2017

Study information

• Verified date: May 2017
• Source: Città di Roma Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 20, 2017
• Est. primary completion date: May 16, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Parturients undergoing epidural block for cesarean section or labor analgesia

Exclusion Criteria:

Related Conditions & MeSH terms

• Epidural

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Città di Roma Hospital

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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