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Clinical Trials/NCT06371456
NCT06371456UnknownNot Applicable

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

Ain Shams University0 sites100 target enrollmentStarted: June 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Primary Endpoint
appearance of the dew sign

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

epidural anesthesia

Experimental

Intervention: epidural catheter placement (Procedure)

Outcomes

Primary Outcomes

appearance of the dew sign

Time Frame: immediately during aspiration of the epidural catheter

dew formation inside the outer portion of the epidural catheter near the patient

Secondary Outcomes

  • mean blood pressure(30 minutes after epidural injection by 10 milliliter bupivacaine 0.25%)
  • heart rate(30 minutes after epidural injection by 10 milliliter bupivacaine 0.25%)
  • epidurogram(immediately after epidural catheter insertion)
  • visual analogue score(20 minutes after epidural injection by 10 milliliter bupivacaine 0.25%)
  • mean blood pressure(20 minutes after epidural injection by 10 milliliter bupivacaine 0.25%)
  • heart rate(20 minutes after epidural injection by 10 milliliter bupivacaine 0.25%)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

RAMY AHMED

Assistant Professor of Anesthesia

Ain Shams University

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