Normal Delivery PainNCT06371456
A Non Invasive Confirmatory Sign for Correct Epidural Catheter Placement During Normal Vaginal Delivery
A study testing epidural catheter placement in people with Normal Delivery Pain, run by Ain Shams University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Normal Delivery Pain
- What is being tested?
- epidural catheter placement
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Parturient for normal vaginal delivery
- American society of anesthesiologists 2
Who cannot join
- 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
About this study
Official title: Anon Invasive Confirmatory Sign for Correct Epidural Catheter Placement During Normal Vaginal Delivery
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.
Read more
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.
Read the 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
- Conditions
- Normal Delivery Pain
- Being tested
- epidural catheter placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural catheter placementProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| epidural anesthesia | Experimental | Not described Receives: Procedure: epidural catheter placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
appearance of the dew sign
dew formation inside the outer portion of the epidural catheter near the patient
Measured: immediately during aspiration of the epidural catheter
Secondary outcomes (6)
epidurogram
by 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
Measured: immediately after epidural catheter insertion
visual analogue score
making a handwritten mark on a 10 cm line that represents a continuum between "no pain" and "worst pain"
Measured: 20 minutes after epidural injection by 10 milliliter bupivacaine 0.25%
mean blood pressure
by non invasive monitor
Measured: 20 minutes after epidural injection by 10 milliliter bupivacaine 0.25%
mean blood pressure
by non invasive monitor
Measured: 30 minutes after epidural injection by 10 milliliter bupivacaine 0.25%
heart rate
by non invasive monitor
Measured: 20 minutes after epidural injection by 10 milliliter bupivacaine 0.25%
heart rate
by non invasive monitor
Measured: 30 minutes after epidural injection by 10 milliliter bupivacaine 0.25%
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Delivery PainStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMY AHMED, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371456
- Sponsor's protocol ID
- Ain Shams university 111
- Status last verified
- Apr 2024
- First submitted
- 14 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anon Invasive Confirmatory Sign for Correct Epidural Catheter Placement During Normal Vaginal Delivery
- ClinicalTrials.gov ID
- NCT06371456
- Acronym / sponsor ID
- Ain Shams university 111
- Conditions
- Normal Delivery Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| epidural anesthesia | Experimental | Procedure: epidural catheter placement |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Parturient for normal vaginal delivery
- American society of anesthesiologists 2
Key exclusion criteria (7 listed)
- patients refusal
- back infection
- anticoagulant non stopped
- platelets count less than 100000
- international normalization ratio more than 1.4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epidural catheter placementafter 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 | Procedure or surgery | epidural anesthesia |
Primary outcome
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
6 secondary outcomes
epidurogram
Time frame: immediately after epidural catheter insertion
visual analogue score
Time frame: 20 minutes after epidural injection by 10 milliliter bupivacaine 0.25%
mean blood pressure
Time frame: 20 minutes after epidural injection by 10 milliliter bupivacaine 0.25%
mean blood pressure
Time frame: 30 minutes after epidural injection by 10 milliliter bupivacaine 0.25%
heart rate
Time frame: 20 minutes after epidural injection by 10 milliliter bupivacaine 0.25%
heart rate
Time frame: 30 minutes after epidural injection by 10 milliliter bupivacaine 0.25%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing epidural catheter placement in people with Normal Delivery Pain, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
appearance of the dew sign (time frame: immediately during aspiration of the epidural catheter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.