Dural Puncture Epidural TechniqueNCT04921761
Dural Puncture Epidural Technique Versus Conventional Epidural Technique During Vaginal Surgeries
A study testing Conventional epidural and Dural puncture epidural in people with Dural Puncture Epidural Technique, run by National Research Centre, Egypt.
Trial summary
The study aims to evaluate whether the dural puncture epidural technique (group B) improves sacral block anesthesia during vaginal surgeries compared with the conventional epidural technique (group A). Read more about this study
- Who is it for?
- Ages 25 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dural Puncture Epidural Technique
- What is being tested?
- Conventional epidural and Dural puncture epidural
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 1 Nov 2021
- 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 25 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age (25- 55) years. Height (150 -170) cm.
Who cannot join
- Patient refusal. Hypersensitivity to local anesthetic drugs. Bleeding disorders and coagulopathy. Severe mitral or aortic stenosis. Local or systemic sepsis. Uncooperative patients. Sever spinal deformity. Blood or CSF in the epidural catheter during the procedure. Failure of the block and need for general anesthesia.
About this study
The study aims to evaluate whether the dural puncture epidural technique (group B) improves sacral block anesthesia during vaginal surgeries compared with the conventional epidural technique (group A).
- Conditions
- Dural Puncture Epidural Technique
- Being tested
- Conventional epidural, Dural puncture epidural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional epiduralProcedure or surgery
In this group, a 20-gauge multi-orifice catheter was threaded through the cephalic-directed tip of the epidural needle 5 cm into the epidural space.
Dural puncture epiduralProcedure or surgery
In this group, the dura was punctured by 25G Whitacre needle. After confirmation of CSF flow, the needle was removed and the epidural catheter was threaded.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | Women who received the conventional epidural technique (group A). Intervention: Procedure: Conventional epidural Receives: Procedure: Conventional epidural |
| Group B | Active comparator | Women who received the dural puncture epidural technique (group B). Intervention: Procedure: Dural puncture epidural Receives: Procedure: Dural puncture epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of onset of anesthesia to T10
Measured: During surgery
Time for complete motor block
Measured: During surgery
Time for first rescue analgesia will be required during surgery
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Jul 2021
- Primary completion1 Oct 2021
- Study completion1 Nov 2021
Why it stopped: There is a duplicate study registered. The trial registration and later updates will be in NCT04933500. That is the record that will be updated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dural Puncture Epidural TechniqueStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921761
- Sponsor's protocol ID
- Dural Puncture
- Status last verified
- Nov 2021
- First submitted
- 5 Jun 2021
- Last updated
- 22 Nov 2021
- 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 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dural Puncture Epidural Technique Versus Conventional Epidural Technique During Vaginal Surgeries
- ClinicalTrials.gov ID
- NCT04921761
- Acronym / sponsor ID
- Dural Puncture
- Conditions
- Dural Puncture Epidural Technique
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: There is a duplicate study registered. The trial registration and later updates will be in NCT04933500. That is the record that will be updated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 10 Jun 2021 (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.
The study aims to evaluate whether the dural puncture epidural technique (group B) improves sacral block anesthesia during vaginal surgeries compared with the conventional epidural technique (group A).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Procedure: Conventional epiduralWomen who received the conventional epidural technique (group A). Intervention: Procedure: Conventional epidural |
| Group B | Active comparator | Procedure: Dural puncture epiduralWomen who received the dural puncture epidural technique (group B). Intervention: Procedure: Dural puncture epidural |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age (25- 55) years. Height (150 -170) cm.
Key exclusion criteria (1 listed)
- Patient refusal. Hypersensitivity to local anesthetic drugs. Bleeding disorders and coagulopathy. Severe mitral or aortic stenosis. Local or systemic sepsis. Uncooperative patients. Sever spinal deformity. Blood or CSF in the epidural catheter during the procedure. Failure of the block and need for general anesthesia.
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 |
|---|---|---|
| Conventional epiduralIn this group, a 20-gauge multi-orifice catheter was threaded through the cephalic-directed tip of the epidural needle 5 cm into the epidural space. | Procedure or surgery | Group A |
| Dural puncture epiduralIn this group, the dura was punctured by 25G Whitacre needle. After confirmation of CSF flow, the needle was removed and the epidural catheter was threaded. | Procedure or surgery | Group B |
Primary outcome
Time of onset of anesthesia to T10
Time frame: During surgery
Time for complete motor block
Time frame: During surgery
Time for first rescue analgesia will be required during surgery
Time frame: During surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
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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 Conventional epidural and Dural puncture epidural in people with Dural Puncture Epidural Technique, run by National Research Centre, Egypt.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 22 Nov 2021. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Time of onset of anesthesia to T10 (time frame: During surgery). The study lists 3 primary outcomes in all. 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 22 Nov 2021.