Labour AnalgesiaPhase 3NCT07327918
Effect of Epidural Needle Injection on Catheter Placement Success During Painless Labour
A Phase 3 study testing Injection Group in people with Labour Analgesia, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Epidural analgesia is the gold standard for painless labour, but successful catheter placement can be technically challenging due to anatomical and physiological changes in pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Labour Analgesia
- What is being tested?
- Injection Group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jun 2026to 15 Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged 18-40 years.
- ASA physical status II or III.
- Singleton pregnancy.
- Gestational age ≥37 weeks.
- Active labour with cervical dilatation ≥3 cm.
- Cephalic presentation.
- Requesting epidural analgesia for painless labour.
- Ability to provide written informed consent.
Who cannot join
- • Refusal to participate or to sign informed consent.
- Age <18 or >40 years.
- ASA status ≥IV.
- Allergy to local anesthetics or saline.
- Coagulopathy or platelet count <100,000/mm³.
- Local infection at the insertion site.
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- Severe spinal deformity (scoliosis, kyphosis).
- Multiple pregnancy.
- Non-cephalic presentation (breech, transverse).
- Antepartum hemorrhage or placenta previa.
- Severe preeclampsia or eclampsia.
- Signs of fetal distress.
- Previous lumbar spine surgery.
- Difficult epidural anatomy (on ultrasound or palpation).
- BMI >40 kg/m²
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Al-Azhar University
Cairo, Egypt, 11865
Neveen A. Kohaf, PhD, 01060383012, nevenabdo@azhar.edu.eg
Hany Baumy, M.D
About this study
Official title: Effect of Epidural Needle Injection on Catheter Placement Success During Painless Labour: A Prospective Randomized Study
Epidural analgesia is the gold standard for painless labour, but successful catheter placement can be technically challenging due to anatomical and physiological changes in pregnancy. Injecting saline or local anesthetic through the epidural needle before catheter insertion has been proposed to facilitate catheter advancement by dilating the epidural space. This study aimed to evaluate the effect of epidural needle injection on the success rate and ease of catheter placement during labour analgesia.
- Conditions
- Labour Analgesia
- Being tested
- Injection Group, Control group
- Keywords
- Epidural Needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection GroupProcedure or surgery
Patients will receive [10 ml of local anesthetic] through an epidural needle before catheter advancement.
Control groupOther
No injection before catheter insertion.
| Study group | Role | What they receive |
|---|---|---|
| Injection group | Experimental | Patients will receive [10 ml of local anaesthetic] through an epidural needle before catheter advancement. Receives: Procedure: Injection Group |
| Control group | Placebo comparator | No injection before catheter insertion. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of epidural catheterization on the first attempt.
The incidence of success of epidural catheterization on the first attempt will be determined. This measures whether the epidural catheter is successfully inserted on the first attempt after loss of resistance, without the need for repositioning or reattempt. Success is defined by obtaining adequate analgesia with proper catheter function (confirmed by clinical effect).
Measured: Assessed immediately during the procedure at the time of epidural catheter placement.
Secondary outcomes (5)
Number of catheterization attempts
Counts the total number of insertion attempts required to achieve correct epidural catheter placement, reflecting technical ease and procedural efficiency.
Measured: Assessed during the procedure until successful catheterization is achieved.
Procedure duration
Measures the time elapsed between needle insertion and successful catheter placement, expressed in minutes. Shorter duration indicates greater ease of insertion.
Measured: Assessed intraoperatively, recorded from the beginning of the puncture until catheter fixation.
Incidence of numbness
Records any occurrence of unexpected or abnormal sensory numbness following the epidural test dose or analgesic administration, which may indicate uneven drug spread or misplaced catheter.
Measured: Assessed post-catheter insertion, within the first 30 minutes after drug administration.
Incidence of unintended dural puncture
Identifies accidental dural puncture events occurring during epidural space entry or catheter advancement.
Measured: Assessed immediately at the time of needle insertion or catheter placement.
Maternal satisfaction
Evaluates the mother's satisfaction regarding the analgesia quality, comfort during the procedure, and overall experience. Typically rated using a structured satisfaction scale. Maternal satisfaction can be measured on a 0-5 scale using a simple 5-point Likert-type item: 0 = completely dissatisfied, 1 = dissatisfied, 2 = neutral, 3 = satisfied, and 4 = very satisfied.
Measured: Assessed post-delivery, usually within 24 hours after labour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start28 Jun 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labour AnalgesiaStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Principal investigator, Neveen Abd El Maksoad Kohaf, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327918
- Sponsor's protocol ID
- RC.11.9.2025
- Status last verified
- Dec 2025
- First submitted
- 26 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared upon reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Epidural Needle Injection on Catheter Placement Success During Painless Labour: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07327918
- Acronym / sponsor ID
- RC.11.9.2025
- Conditions
- Labour Analgesia
- Keywords
- Epidural Needle
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- Benha University
- Study start
- 28 Jun 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 8 Jan 2026 (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 analgesia is the gold standard for painless labour, but successful catheter placement can be technically challenging due to anatomical and physiological changes in pregnancy. Injecting saline or local anesthetic through the epidural needle before catheter insertion has been proposed to facilitate catheter advancement by dilating the epidural space. This study aimed to evaluate the effect of epidural needle injection on the success rate and ease of catheter placement during labour analgesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injection group | Experimental | Procedure: Injection GroupPatients will receive [10 ml of local anaesthetic] through an epidural needle before catheter advancement. |
| Control group | Placebo comparator | Other: Control groupNo injection before catheter insertion. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Female patients aged 18-40 years.
- ASA physical status II or III.
- Singleton pregnancy.
- Gestational age ≥37 weeks.
- Active labour with cervical dilatation ≥3 cm.
Key exclusion criteria (15 listed)
- • Refusal to participate or to sign informed consent.
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 |
|---|---|---|
| Injection GroupPatients will receive [10 ml of local anesthetic] through an epidural needle before catheter advancement. | Procedure or surgery | Injection group |
| Control groupNo injection before catheter insertion. | Other | Control group |
Primary outcome
Success of epidural catheterization on the first attempt.
Time frame: Assessed immediately during the procedure at the time of epidural catheter placement.
The incidence of success of epidural catheterization on the first attempt will be determined. This measures whether the epidural catheter is successfully inserted on the first attempt after loss of resistance, without the need for repositioning or reattempt. Success is defined by obtaining adequate analgesia with proper catheter function (confirmed by clinical effect).
5 secondary outcomes
Number of catheterization attempts
Time frame: Assessed during the procedure until successful catheterization is achieved.
Procedure duration
Time frame: Assessed intraoperatively, recorded from the beginning of the puncture until catheter fixation.
Incidence of numbness
Time frame: Assessed post-catheter insertion, within the first 30 minutes after drug administration.
Incidence of unintended dural puncture
Time frame: Assessed immediately at the time of needle insertion or catheter placement.
Maternal satisfaction
Time frame: Assessed post-delivery, usually within 24 hours after labour.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: Yes. Data can be shared upon reasonable request from the corresponding author
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Injection Group in people with Labour Analgesia, run by Al-Azhar University 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 8 inclusion and 15 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: opening soon, as of the sponsor's last update on 8 Jan 2026. 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. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neveen A Kohaf, Ph.D (+201060383012, nevenabdo@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of epidural catheterization on the first attempt. (time frame: Assessed immediately during the procedure at the time of epidural catheter placement.). 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 8 Jan 2026.