A Non Invasive Confirmatory Sign for Correct Epidural Catheter Placement During Normal Vaginal Delivery

Anon Invasive Confirmatory Sign for Correct Epidural Catheter Placement During Normal Vaginal Delivery

Epidural anesthesia for pain control during normal vaginal delivery is a blind maneuver and so we need a confirmatory sign for being in the correct epidural space.

Loss of resistance sign using air may guide us wrongly as it may occur if we entered into the paravertebral muscles or cavities in the interspinal ligaments.

So, additional confirmatory sign beside loss of resistance sign by air is strongly needed.

We noticed that after occurence of loss of resistance sign by air and insertion of the epidural catheter a dew was formed on the internal sides of the epidural catheter after aspiration to be sure that there are no blood or cerebrospinal fluid in the catheter.

This dew formation (Ramy sign) is characteristic for air in the epidural space when transferred from the warm epidural space (temperature about 38-39 celsius degree) to the colder aspect of the catheter outside the patient which nearly has the same operating room temperature (22 celsius degree).

This sign may be associated with correct placement and good function of the epidural catheter.

Study Overview

• Status: Not yet recruiting
• Conditions: Normal Delivery Pain
• Intervention / Treatment: Procedure: epidural catheter placement

Detailed Description

parturient for normal vaginal delivery are examined for correct epidural catheter placement by loss of resistance technique by air, observation of the dew sign and epidurogram.

Visual analogue score is used to test pain. blood pressure and heart rate after epidural injection will be monitored

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Parturient for normal vaginal delivery
• American society of anesthesiologists 2

Exclusion Criteria:

• patients refusal
• back infection
• anticoagulant non stopped
• platelets count less than 100000
• international normalization ratio more than 1.4
• severe cardiac or respiratory diseases
• haemodynamics unstable patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: epidural anesthesia

Procedure: epidural catheter placement; after sterilization of the back, local anesthesia injection (xylocaine 5 ml) at lumbar 4-5 level, then advancing the epidural needle till loss of resistance by air occurs and the epidural catheter inserted then aspiration through the catheter will be done to confirm that no accidental cerebrospinal fluid or blood are aspirated and to observe the dew sign inside the outer portion of the epidural catheter near the back of the patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
appearance of the dew sign	dew formation inside the outer portion of the epidural catheter near the patient	immediately during aspiration of the epidural catheter

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
epidurogram	by using posteroanterior x-ray image after injection of radiopaque dye through the epidural catheter with appearance of distribution of the dye in the epidural space and may exit through the neuroforamina laterally	immediately after epidural catheter insertion
visual analogue score	making a handwritten mark on a 10 cm line that represents a continuum between "no pain" and "worst pain"	20 minutes after epidural injection by 10 milliliter bupivacaine 0.25%
mean blood pressure	by non invasive monitor	20 minutes after epidural injection by 10 milliliter bupivacaine 0.25%
mean blood pressure	by non invasive monitor	30 minutes after epidural injection by 10 milliliter bupivacaine 0.25%
heart rate	by non invasive monitor	20 minutes after epidural injection by 10 milliliter bupivacaine 0.25%
heart rate	by non invasive monitor	30 minutes after epidural injection by 10 milliliter bupivacaine 0.25%

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: April 14, 2024
• First Submitted That Met QC Criteria: April 14, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 14, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Ain Shams university 111

Drug and device information, study documents

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