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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06371456
Enrollment
100
Registered
2024-04-17
Start date
2024-06-01
Completion date
2025-08-01
Last updated
2024-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Delivery Pain

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

Interventions

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
appearance of the dew signimmediately during aspiration of the epidural catheterdew formation inside the outer portion of the epidural catheter near the patient

Secondary

MeasureTime frameDescription
epidurogramimmediately after epidural catheter insertionby 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
visual analogue score20 minutes after epidural injection by 10 milliliter bupivacaine 0.25%making a handwritten mark on a 10 cm line that represents a continuum between no pain and worst pain
mean blood pressure20 minutes after epidural injection by 10 milliliter bupivacaine 0.25%by non invasive monitor
heart rate20 minutes after epidural injection by 10 milliliter bupivacaine 0.25%by non invasive monitor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026