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

A

Ain Shams University

Status

Not yet enrolling

Conditions

Normal Delivery Pain

Treatments

Procedure: epidural catheter placement

Study type

Interventional

Funder types

Other

Identifiers

NCT06371456
Ain Shams university 111

Details and patient eligibility

About

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.

Full 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

Enrollment

100 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

epidural anesthesia
Experimental group
Treatment:
Procedure: epidural catheter placement

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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