Labour AnalgesiaPhase 1NCT07332130
Spinal Analgesia in Labour Pain
A Phase 1 study testing injecting dexmedetomidine and injecting mixture of bupivacaine fentanyl in people with Labour Analgesia, run by Minia University Hospital at 1 site in Egypt.
Trial summary
To evaluate the efficacy and safety of dexmedetomidine as an adjuvant to bupivacain and fentanyl in spinal Analgesia to decreases pain during normal labour Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labour Analgesia
- What is being tested?
- injecting dexmedetomidine and injecting mixture of bupivacaine fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Dec 2025to 2 Mar 2026
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age of patint is between 18 and 40 years. gestational age of fetus is more than 37 weeks. singleton viable fetus and cephalic presentation. spontaneous labor with cervix dilation more than 5cm.
Who cannot join
- Drug allergy. Blood Disease. Infection at site of injection. patient takes anticoagulants. patient has pre-eclampsia ,cardiac disease (NYHA III-IV) or diabetes mellitus type I prior to the pregnancy patients refuse
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
Minya
Minya, 61915
mohamed ragab, master degree, 086-01001737436, mohamedragab2209@gmail.com
About this study
Official title: Effect of Adding Dexmedetomidine to Bupivacain _fentanyl Mixture in Spinal Analgesia for Normal Labour
To evaluate the efficacy and safety of dexmedetomidine as an adjuvant to bupivacain and fentanyl in spinal Analgesia to decreases pain during normal labour
Read the detailed description
Effect of adding dexmedetomidine to bupivacain fentanyl mixture in spinal analgesia for normal labour
- Conditions
- Labour Analgesia
- Being tested
- injecting dexmedetomidine, injecting mixture of bupivacaine fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injecting dexmedetomidineDrug
injecting dexmedetomidine intrathecally during labour pain
injecting mixture of bupivacaine fentanylDrug
injecting mixture of bupivacaine fentanyl intrathecally
| Study group | Role | What they receive |
|---|---|---|
| DEX | Active comparator | Participants receive intrathecaliy hyperbaric bupivacaine 2.5 mg (0.5 mL) combined with dexmedetomidine 2.5 µg and fentanyl 25 µg, diluted to a total volume of 2.5 mL. The solution will be administered as a single spinal injection under aseptic conditions. Receives: Drug: injecting dexmedetomidine |
| CONTROLLED | Active comparator | Participants will receive intrathecaliy hyperbaric bupivacaine 2.5 mg (0.5 mL) combined with fentanyl 25 µg, diluted to a total volume of 2.5 mL. The solution will be administered as a single spinal injection under aseptic conditions. Receives: Drug: injecting mixture of bupivacaine fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in numeric pain intensity score ( NPSI) maximum 10 minimum 0
evaluate the safety and effecacy of dexmetomidine for labour pain by numeric pain intensity score maximum 10 ( sever pain ), minimum 0 ( no pain )
Measured: baseline
duration of sensory blockade
change in numeric pain intensity score ( NPIS )
Measured: 5 minutes after injection of analgesic agents till normal delivery done
changes in numeric pain intensity score ( NPIS )
Scores range from 0-10 points, maximum ( 10 ) means sever pain, minimum ( 0 ) means no pain
Measured: 5 minutes, 10 minutes, 15 minutes, 30 minutes and 45 minintes after injection of analgesic agents
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start24 Dec 2025 (estimated)
- Primary completion10 Jan 2026 (estimated)
- Study completion2 Mar 2026 (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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- effect of adding dexmetomidine to bupivcain fentanyl mixture in spinal analgesia for normal labour
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ragab Mohamed, Minia University Hospital
- Investigators
- Mohamed Ragab, master, Principal investigator, Minia University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332130
- Sponsor's protocol ID
- 1337/11/2024
- Status last verified
- Oct 2025
- First submitted
- 2 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD,
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Dexmedetomidine to Bupivacain _fentanyl Mixture in Spinal Analgesia for Normal Labour
- ClinicalTrials.gov ID
- NCT07332130
- Acronym / sponsor ID
- 1337/11/2024
- Conditions
- Labour Analgesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Minia University HospitalUniversity, hospital or other
- Study start
- 24 Dec 2025 (estimated)
- Primary completion
- 10 Jan 2026 (estimated)
- Study completion
- 2 Mar 2026 (estimated)
- First posted
- 12 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.
To evaluate the efficacy and safety of dexmedetomidine as an adjuvant to bupivacain and fentanyl in spinal Analgesia to decreases pain during normal labour
Detailed description
Effect of adding dexmedetomidine to bupivacain fentanyl mixture in spinal analgesia for normal labour
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- effect of adding dexmetomidine to bupivcain fentanyl mixture in spinal analgesia for normal labour
| Arm | Type | Receives |
|---|---|---|
| DEX | Active comparator | Drug: injecting dexmedetomidineParticipants receive intrathecaliy hyperbaric bupivacaine 2.5 mg (0.5 mL) combined with dexmedetomidine 2.5 µg and fentanyl 25 µg, diluted to a total volume of 2.5 mL. The solution will be administered as a single spinal injection under aseptic conditions. |
| CONTROLLED | Active comparator | Drug: injecting mixture of bupivacaine fentanylParticipants will receive intrathecaliy hyperbaric bupivacaine 2.5 mg (0.5 mL) combined with fentanyl 25 µg, diluted to a total volume of 2.5 mL. The solution will be administered as a single spinal injection under aseptic conditions. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age of patint is between 18 and 40 years. gestational age of fetus is more than 37 weeks. singleton viable fetus and cephalic presentation. spontaneous labor with cervix dilation more than 5cm.
Key exclusion criteria (1 listed)
- Drug allergy. Blood Disease. Infection at site of injection. patient takes anticoagulants. patient has pre-eclampsia ,cardiac disease (NYHA III-IV) or diabetes mellitus type I prior to the pregnancy patients refuse
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 |
|---|---|---|
| injecting dexmedetomidineinjecting dexmedetomidine intrathecally during labour pain | Drug | DEX |
| injecting mixture of bupivacaine fentanylinjecting mixture of bupivacaine fentanyl intrathecally | Drug | CONTROLLED |
Primary outcome
changes in numeric pain intensity score ( NPSI) maximum 10 minimum 0
Time frame: baseline
evaluate the safety and effecacy of dexmetomidine for labour pain by numeric pain intensity score maximum 10 ( sever pain ), minimum 0 ( no pain )
duration of sensory blockade
Time frame: 5 minutes after injection of analgesic agents till normal delivery done
change in numeric pain intensity score ( NPIS )
changes in numeric pain intensity score ( NPIS )
Time frame: 5 minutes, 10 minutes, 15 minutes, 30 minutes and 45 minintes after injection of analgesic agents
Scores range from 0-10 points, maximum ( 10 ) means sever pain, minimum ( 0 ) means no pain
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 12 Jan 2026.
- Individual participant dataSharing planned: Yes. all collected IPD,
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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.
Mohamed Ragab, master principal investigator
Minia University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing injecting dexmedetomidine and injecting mixture of bupivacaine fentanyl in people with Labour Analgesia, run by Minia University Hospital 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 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: opening soon, as of the sponsor's last update on 12 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Mohamed Ragab, Master (086-01001737436, mohamedragab2209@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in numeric pain intensity score ( NPSI) maximum 10 minimum 0 (time frame: baseline). 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 12 Jan 2026.