Clinical trial NCT06371456: A Non Invasive Confirmatory Sign for Correct Epidural Catheter Placement During Normal Vaginal Delivery
Official title: Anon Invasive Confirmatory Sign for Correct Epidural Catheter Placement During Normal Vaginal Delivery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Normal Delivery Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: appearance of the dew sign
timeFrame: immediately during aspiration of the epidural catheter
Secondary outcomes:
measure: epidurogram
timeFrame: immediately after epidural catheter insertion
measure: visual analogue score
timeFrame: 20 minutes after epidural injection by 10 milliliter bupivacaine 0.25%
measure: mean blood pressure
timeFrame: 20 minutes after epidural injection by 10 milliliter bupivacaine 0.25%
measure: mean blood pressure
timeFrame: 30 minutes after epidural injection by 10 milliliter bupivacaine 0.25%
measure: heart rate
timeFrame: 20 minutes after epidural injection by 10 milliliter bupivacaine 0.25%
measure: heart rate
timeFrame: 30 minutes after epidural injection by 10 milliliter bupivacaine 0.25%
Other outcomes:
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