Total Dose of Bupivacaine Administered During LaborNCT07506044
Dexmedetomidine as an Adjuvant During Dural Puncture Epidural
A study testing Epidural Catheter with bupivacaine, Epidural with dural puncture and Dexmedetomidine 0.4 added in people with Total Dose of Bupivacaine Administered During Labor, run by Menoufia University at 1 site in Egypt.
Trial summary
The study aimed to determine the effects of using varied doses of DEX on the concentration of bupivacaine injected for epidural labor analgesia, and to assess the benefits of the dural puncture epidural. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Total Dose of Bupivacaine Administered During Labor
- What is being tested?
- Epidural Catheter with bupivacaine, Epidural with dural puncture and Dexmedetomidine 0.4 added
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2026to 30 Oct 2026
- Phase
- Interventional
- 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
- Women who attend the Emergency Department in labor, with cervical dilation of 3-5 cm,
- normally presented singleton fetus, intact fetal membranes, and who are free of exclusion criteria
Who cannot join
- Abnormal fetal presentation or lie, 'premature rupture of membranes, maternal fever, fetal distress, pregnancy-induced diseases
- abnormal placental position,
- ASA grade>II
- marked obesity,
- allergy or contraindications to the used drugs,
- spinal deformity or disorders 'cutaneous diseases or infection at the injection site
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, 1 recruiting
- Recruiting
Faculty of Medicine Menoufia University
Shebeen El Kom, 32511
Rabab Habeeb, 01001970973, rabab_habeeb@med.menofia.edu.eg
About this study
Official title: The Effect of Different Doses of Dexmedetomidine as an Adjuvant to Bupivacaine for Parturients Having Dural Puncture Epidural Technique to Elaborate Labor Pain
The study aimed to determine the effects of using varied doses of DEX on the concentration of bupivacaine injected for epidural labor analgesia, and to assess the benefits of the dural puncture epidural.
Read the detailed description
The primary efficacy point is the total dose of bupivacaine administered during labor. The secondary endpoints include the VAS pain scores, number of administered additional doses, incidence of motor block, delivery type (spontaneous vaginal or cesarean), maternal satisfaction, and complications such as hypotension, fetal bradycardia, and epidural-related maternal fever.
- Being tested
- Epidural Catheter with bupivacaine, Epidural with dural puncture, Dexmedetomidine 0.4 added, Dexmedetomidine 0.6 added
- Keywords
- Labour, Epidural, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural Catheter with bupivacaineDevice
epidural injection of plain Bup
Epidural with dural punctureDevice
the dura is punctured by a 26-G spinal needle using the needle-through-needle technique, and is withdrawn after confirmation of free-flowing cerebrospinal fluid,
Dexmedetomidine 0.4 addedDrug
Dexmedetomidine 0.4 added
Dexmedetomidine 0.6 addedDrug
Dexmedetomidine 0.6 added
| Study group | Role | What they receive |
|---|---|---|
| Epidural group with bupivacaine CE | Active comparator | Epidural with plain bupivacaine DPE Receives: Device: Epidural Catheter with bupivacaine |
| Epidural puncture with bupivacaine | Active comparator | Combined epidural with epidural puncture using bupivacaine Receives: Device: Epidural Catheter with bupivacaine; Device: Epidural with dural puncture |
| Epidural puncture with dexmedetomidine 0.4 (Bup/DEX0.6 ) | Active comparator | Combined epidural with epidural puncture using bupivacaine plus dexmetomedine0.4 Receives: Device: Epidural Catheter with bupivacaine; Device: Epidural with dural puncture; Drug: Dexmedetomidine 0.4 added |
| Epidural puncture with dexmedetomidine 0.6 (Bup/DEX0.6 ) | Active comparator | Combined epidural with epidural puncture using bupivacaine plus dexmetomedine0.6 Receives: Device: Epidural Catheter with bupivacaine; Device: Epidural with dural puncture; Drug: Dexmedetomidine 0.6 added |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total dose of bupivacaine
Total dose of bupivacaine administered
Measured: From the induction of epidural to the delivery of the fetus
Secondary outcomes (5)
Labor pain
Labour pain measured by Visual analogue
Measured: Before initiation of epidural ,10 ,30,45,60 min after initiation then every 1hour till the delivery of the fetus
Motor block
Motor block measured by bromage scsle
Measured: Before initiation of epidural ,10 ,30,45,60 min after initiation then every 1hour till the delivery of the fetus
Delivery type
Delivery type spontaneous or instrument
Measured: At time of fetus delivery
Maternal satisfaction
Satisfied or not
Measured: Preoperative,2nd stage of labour, third stage of labour and immediately after delivery, 2 hours after delivery,4 hours after delivery,12 hours after delivery
Complications
Any complications detected
Measured: Preoperative,2nd stage of labour, third stage of labour and immediately after delivery, 2 hours after delivery,4 hours after delivery,12 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start30 May 2026
- Primary completion1 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Dose of Bupivacaine Administered During LaborStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rabab Mohammad habeeb, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506044
- Sponsor's protocol ID
- 2/2026ANET2-1
- Status last verified
- Aug 2026
- First submitted
- 16 Mar 2026
- Last updated
- 13 Aug 2026
- 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Doses of Dexmedetomidine as an Adjuvant to Bupivacaine for Parturients Having Dural Puncture Epidural Technique to Elaborate Labor Pain
- ClinicalTrials.gov ID
- NCT07506044
- Acronym / sponsor ID
- 2/2026ANET2-1
- Keywords
- Labour, Epidural, Dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 30 May 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 1 Apr 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.
The study aimed to determine the effects of using varied doses of DEX on the concentration of bupivacaine injected for epidural labor analgesia, and to assess the benefits of the dural puncture epidural.
Detailed description
The primary efficacy point is the total dose of bupivacaine administered during labor. The secondary endpoints include the VAS pain scores, number of administered additional doses, incidence of motor block, delivery type (spontaneous vaginal or cesarean), maternal satisfaction, and complications such as hypotension, fetal bradycardia, and epidural-related maternal fever.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Epidural group with bupivacaine CE | Active comparator | Device: Epidural Catheter with bupivacaineEpidural with plain bupivacaine DPE |
| Epidural puncture with bupivacaine | Active comparator | Device: Epidural Catheter with bupivacaine, Device: Epidural with dural punctureCombined epidural with epidural puncture using bupivacaine |
| Epidural puncture with dexmedetomidine 0.4 (Bup/DEX0.6 ) | Active comparator | Device: Epidural Catheter with bupivacaine, Device: Epidural with dural puncture, Drug: Dexmedetomidine 0.4 addedCombined epidural with epidural puncture using bupivacaine plus dexmetomedine0.4 |
| Epidural puncture with dexmedetomidine 0.6 (Bup/DEX0.6 ) | Active comparator | Device: Epidural Catheter with bupivacaine, Device: Epidural with dural puncture, Drug: Dexmedetomidine 0.6 addedCombined epidural with epidural puncture using bupivacaine plus dexmetomedine0.6 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women who attend the Emergency Department in labor, with cervical dilation of 3-5 cm,
- normally presented singleton fetus, intact fetal membranes, and who are free of exclusion criteria
Key exclusion criteria (6 listed)
- Abnormal fetal presentation or lie, 'premature rupture of membranes, maternal fever, fetal distress, pregnancy-induced diseases
- abnormal placental position,
- ASA grade>II
- marked obesity,
- allergy or contraindications to the used drugs,
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 with bupivacaineepidural injection of plain Bup | Device | Epidural group with bupivacaine CE, Epidural puncture with bupivacaine, Epidural puncture with dexmedetomidine 0.4 (Bup/DEX0.6 ), Epidural puncture with dexmedetomidine 0.6 (Bup/DEX0.6 ) |
| Epidural with dural puncturethe dura is punctured by a 26-G spinal needle using the needle-through-needle technique, and is withdrawn after confirmation of free-flowing cerebrospinal fluid, | Device | Epidural puncture with bupivacaine, Epidural puncture with dexmedetomidine 0.4 (Bup/DEX0.6 ), Epidural puncture with dexmedetomidine 0.6 (Bup/DEX0.6 ) |
| Dexmedetomidine 0.4 addedDexmedetomidine 0.4 added | Drug | Epidural puncture with dexmedetomidine 0.4 (Bup/DEX0.6 ) |
| Dexmedetomidine 0.6 addedDexmedetomidine 0.6 added | Drug | Epidural puncture with dexmedetomidine 0.6 (Bup/DEX0.6 ) |
Primary outcome
Total dose of bupivacaine
Time frame: From the induction of epidural to the delivery of the fetus
Total dose of bupivacaine administered
5 secondary outcomes
Labor pain
Time frame: Before initiation of epidural ,10 ,30,45,60 min after initiation then every 1hour till the delivery of the fetus
Motor block
Time frame: Before initiation of epidural ,10 ,30,45,60 min after initiation then every 1hour till the delivery of the fetus
Delivery type
Time frame: At time of fetus delivery
Maternal satisfaction
Time frame: Preoperative,2nd stage of labour, third stage of labour and immediately after delivery, 2 hours after delivery,4 hours after delivery,12 hours after delivery
Complications
Time frame: Preoperative,2nd stage of labour, third stage of labour and immediately after delivery, 2 hours after delivery,4 hours after delivery,12 hours after delivery
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 13 Aug 2026.
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 study testing Epidural Catheter with bupivacaine, Epidural with dural puncture and Dexmedetomidine 0.4 added in people with Total Dose of Bupivacaine Administered During Labor, run by Menoufia 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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 13 Aug 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. 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?
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 Rabab Habeeb, MD (+201001970973, rabab_habeeb@med.menofia.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total dose of bupivacaine (time frame: From the induction of epidural to the delivery of the fetus). 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 13 Aug 2026.