Anesthesia, ObstetricNCT06184425
Dural Puncture Epidural Technique During Cesarean Section
A study testing Dural Puncture Epidural technique using pencil-point 25G Whitacre needle and Dural Puncture Epidural technique using pencil-point 27G Whitacre needle in people with Anesthesia, Obstetric, run by Reham Ali Abdelhaleem Abdelrahman at 1 site in Egypt.
Trial summary
DPE technique was performed by creating a perforation in the dura mater using a pencil point spinal needle (25-27G) through the shaft of an epidural needle. After the dural perforation was created and the free flow of the cerebrospinal fluid (CSF) was confirmed, which was considered a definitive end point for the… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Anesthesia, Obstetric
- What is being tested?
- Dural Puncture Epidural technique using pencil-point 25G Whitacre needle and Dural Puncture Epidural technique using pencil-point 27G Whitacre needle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2023to 8 Dec 2023
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy pregnant women (ASAI\&II) with singleton vertex presentation cephalic presentation foetus at 38 to 42 weeksꞌ gestation.
- Age: 20-35 years old.
- Weight: 57-85 Kg.
- Height: 155-170cm.
Who cannot join
- Non-elective CS.
- Known foetal anomalies.
- Patient refusal or uncooperative patients.
- Patients with history of drug abuse and maternal diseases (i.e. diabetes mellitus, cardiac disease, heart block/dysrhythmia, hypertension, chronic obstructive respiratory disease, preeclampsia, eclampsia, placenta previa, placental abruption, coagulation abnormalities or hematological diseases).
- Spinal deformities, previous spinal surgeries, allergy to amide type of local anesthetics, localized skin sepsis at spinal lumbar region, neurological diseases, peripheral neuropathy, neuromuscular diseases, psychiatric diseases, hepatic and renal diseases, metabolic and endocrinal diseases and Raynaud's disease.
- Severe hypovolemia, severe hemodynamic instability and patients with anemia (Hb <10 gm %).
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- Morbidly obese (BMI > 35 kg/m2) patients.
- Those who are very short (<150cm) or very tall (>170 cm).
- Patients on therapy with adrenergic receptor antagonist, anticoagulants, calcium channel blocker, and/or ACE inhibitor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparative Study Between 25-Gauge and 27-Gauage Pencil Point Spinal Needles During Dural Puncture Epidural Anaesthesia For Elective Caesarean Section
DPE technique was performed by creating a perforation in the dura mater using a pencil point spinal needle (25-27G) through the shaft of an epidural needle. After the dural perforation was created and the free flow of the cerebrospinal fluid (CSF) was confirmed, which was considered a definitive end point for the likely positioning of the epidural needle tip within the epidural space, and by avoiding direct intrathecal administration of medication making DPE technique of fewer adverse effects in comparison to CSE technique, then spinal needle was withdrawn without local anesthetic injection into the subarachnoid space and the epidural catheter was normally placed in the epidural space followed by injecting local anesthetics into the epidural space via the epidural catheter, where the dural puncture created a conduit for translocation of local anesthetics from the epidural space to the subarachnoid space which was a unique feature of DPE technique.
Our study assessed the efficacy of DPE with pencil point spinal needle (25-27 G) during elective CS. Primary outcome was the onset time of surgical anesthesia which is defined as the time from the end of the initial dose injection to when the bilateral sensory block level reached the T6 dermatome. secondary outcomes were number of patients with cranial sensory block toT6 Level, number of patients with a modified bromage score reaching 3 at 15 min, intraoperative IV analgesia, local anesthetic volume, incidence of vasopressor administration and maternal \&fetal complications.
- Conditions
- Anesthesia, Obstetric
- Being tested
- Dural Puncture Epidural technique using pencil-point 25G Whitacre needle, Dural Puncture Epidural technique using pencil-point 27G Whitacre needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dural Puncture Epidural technique using pencil-point 25G Whitacre needleProcedure or surgery
- DPE technique was performed in the sitting position at the L3/4 or L4/5 interspace via the midline approach using a 17-gauge Touhy needle and a loss of resistance to saline technique, then the dura was punctured with a 25-gauge pencil point Whitacre spinal needles using a needle-through-needle technique, and spontaneous flow of cerebrospinal fluid was confirmed, then the spinal needle was removed and a flexible 19-gauge, spring closed-tip catheter was inserted 5 cm into the epidural space toward the cranial side.
Dural Puncture Epidural technique using pencil-point 27G Whitacre needleProcedure or surgery
- DPE technique was performed in the sitting position at the L3/4 or L4/5 interspace via the midline approach using a 17-gauge Touhy needle and a loss of resistance to saline technique, then the dura was punctured with a 27-gauage pencil point Whitacre spinal needles using a needle-through-needle technique, and spontaneous flow of cerebrospinal fluid was confirmed, then the spinal needle was removed and a flexible 19-gauge, spring closed-tip catheter was inserted 5 cm into the epidural space toward the cranial side.
| Study group | Role | What they receive |
|---|---|---|
| Dural Puncture Epidural technique using pencil-point 25G Whitacre needle | Active comparator | Not described Receives: Procedure: Dural Puncture Epidural technique using pencil-point 27G Whitacre needle |
| Dural Puncture Epidural technique using 27 G Whitacre needle | Experimental | Not described Receives: Procedure: Dural Puncture Epidural technique using pencil-point 25G Whitacre needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
was the onset time to surgical anesthesia
was defined as the time from the end of the intraoperative epidural test dose injection [the start of epidural extension anaesthesia (time zero on the stopwatch)] to when the sensory block level reached the T6 dermatome bilaterally (when the patient could no longer feel sharp sensation at T6) (assessed bilaterally at the midclavicular line)
Measured: up to 20 minutes after local anesthetic injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start10 Jan 2023
- Primary completion6 Nov 2023
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, ObstetricStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reham Ali Abdelhaleem Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reham Ali Abdelhaleem Abdelrahman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184425
- Sponsor's protocol ID
- IF-2023
- Status last verified
- May 2024
- First submitted
- 14 Dec 2023
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparative Study Between 25-Gauge and 27-Gauage Pencil Point Spinal Needles During Dural Puncture Epidural Anaesthesia For Elective Caesarean Section
- ClinicalTrials.gov ID
- NCT06184425
- Acronym / sponsor ID
- IF-2023
- Conditions
- Anesthesia, Obstetric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Reham Ali Abdelhaleem AbdelrahmanUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 6 Nov 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 28 Dec 2023 (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.
DPE technique was performed by creating a perforation in the dura mater using a pencil point spinal needle (25-27G) through the shaft of an epidural needle. After the dural perforation was created and the free flow of the cerebrospinal fluid (CSF) was confirmed, which was considered a definitive end point for the likely positioning of the epidural needle tip within the epidural space, and by avoiding direct intrathecal administration of medication making DPE technique of fewer adverse effects in comparison to CSE technique, then spinal needle was withdrawn without local anesthetic injection into the subarachnoid space and the epidural catheter was normally placed in the epidural space followed by injecting local anesthetics into the epidural space via the epidural catheter, where the dural puncture created a conduit for translocation of local anesthetics from the epidural space to the subarachnoid space which was a unique feature of DPE technique.
Our study assessed the efficacy of DPE with pencil point spinal needle (25-27 G) during elective CS. Primary outcome was the onset time of surgical anesthesia which is defined as the time from the end of the initial dose injection to when the bilateral sensory block level reached the T6 dermatome. secondary outcomes were number of patients with cranial sensory block toT6 Level, number of patients with a modified bromage score reaching 3 at 15 min, intraoperative IV analgesia, local anesthetic volume, incidence of vasopressor administration and maternal \&fetal complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dural Puncture Epidural technique using pencil-point 25G Whitacre needle | Active comparator | Procedure: Dural Puncture Epidural technique using pencil-point 27G Whitacre needle |
| Dural Puncture Epidural technique using 27 G Whitacre needle | Experimental | Procedure: Dural Puncture Epidural technique using pencil-point 25G Whitacre needle |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy pregnant women (ASAI\&II) with singleton vertex presentation cephalic presentation foetus at 38 to 42 weeksꞌ gestation.
- Age: 20-35 years old.
- Weight: 57-85 Kg.
- Height: 155-170cm.
Key exclusion criteria (9 listed)
- Non-elective CS.
- Known foetal anomalies.
- Patient refusal or uncooperative patients.
- Patients with history of drug abuse and maternal diseases (i.e. diabetes mellitus, cardiac disease, heart block/dysrhythmia, hypertension, chronic obstructive respiratory disease, preeclampsia, eclampsia, placenta previa, placental abruption, coagulation abnormalities or hematological diseases).
- Spinal deformities, previous spinal surgeries, allergy to amide type of local anesthetics, localized skin sepsis at spinal lumbar region, neurological diseases, peripheral neuropathy, neuromuscular diseases, psychiatric diseases, hepatic and renal diseases, metabolic and endocrinal diseases and Raynaud's disease.
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 |
|---|---|---|
| Dural Puncture Epidural technique using pencil-point 25G Whitacre needle- DPE technique was performed in the sitting position at the L3/4 or L4/5 interspace via the midline approach using a 17-gauge Touhy needle and a loss of resistance to saline technique, then the dura was punctured with a 25-gauge pencil point Whitacre spinal needles using a needle-through-needle technique, and spontaneous flow of cerebrospinal fluid was confirmed, then the spinal needle was removed and a flexible 19-gauge, spring closed-tip catheter was inserted 5 cm into the epidural space toward the cranial side. | Procedure or surgery | Dural Puncture Epidural technique using 27 G Whitacre needle |
| Dural Puncture Epidural technique using pencil-point 27G Whitacre needle- DPE technique was performed in the sitting position at the L3/4 or L4/5 interspace via the midline approach using a 17-gauge Touhy needle and a loss of resistance to saline technique, then the dura was punctured with a 27-gauage pencil point Whitacre spinal needles using a needle-through-needle technique, and spontaneous flow of cerebrospinal fluid was confirmed, then the spinal needle was removed and a flexible 19-gauge, spring closed-tip catheter was inserted 5 cm into the epidural space toward the cranial side. | Procedure or surgery | Dural Puncture Epidural technique using pencil-point 25G Whitacre needle |
Primary outcome
was the onset time to surgical anesthesia
Time frame: up to 20 minutes after local anesthetic injection
was defined as the time from the end of the intraoperative epidural test dose injection [the start of epidural extension anaesthesia (time zero on the stopwatch)] to when the sensory block level reached the T6 dermatome bilaterally (when the patient could no longer feel sharp sensation at T6) (assessed bilaterally at the midclavicular line)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dural Puncture Epidural technique using pencil-point 25G Whitacre needle and Dural Puncture Epidural technique using pencil-point 27G Whitacre needle in people with Anesthesia, Obstetric, run by Reham Ali Abdelhaleem Abdelrahman at 1 site in 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
was the onset time to surgical anesthesia (time frame: up to 20 minutes after local anesthetic injection). 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 20 May 2024.