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

NCT06371456 | Not Yet Recruiting

• 1 other identifier: Ain Shams university 111
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Normal Delivery Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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%

• mean blood pressure

  30 minutes after epidural injection by 10 milliliter bupivacaine 0.25%

• heart rate

  20 minutes after epidural injection by 10 milliliter bupivacaine 0.25%

Study Arms (1)

epidural anesthesia

EXPERIMENTAL

Procedure: epidural catheter placement

Interventions

epidural catheter placement PROCEDURE

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

epidural anesthesia

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia

Study Record Dates

• First Submitted: April 14, 2024
• First Posted: April 17, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-04