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Dexmedetomidine as an Adjuvant During Dural Puncture Epidural

The Effect of Different Doses of Dexmedetomidine as an Adjuvant to Bupivacaine for Parturients Having Dural Puncture Epidural Technique to Elaborate Labor Pain

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07506044
Enrollment
140
Registered
2026-04-01
Start date
2026-05-30
Completion date
2026-10-30
Last updated
2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Dose of Bupivacaine Administered During Labor

Keywords

Labour, Epidural, Dexmedetomidine

Brief 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.

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.

Interventions

DEVICEEpidural Catheter with bupivacaine

epidural injection of plain Bup

DEVICEEpidural with dural puncture

the dura is punctured by a 26-G spinal needle using the needle-through-needle technique, and is withdrawn after confirmation of free-flowing cerebrospinal fluid,

DRUGDexmedetomidine 0.4 added

Dexmedetomidine 0.4 added

DRUGDexmedetomidine 0.6 added

Dexmedetomidine 0.6 added

Sponsors

Menoufia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Total dose of bupivacaineFrom the induction of epidural to the delivery of the fetusTotal dose of bupivacaine administered

Secondary

MeasureTime frameDescription
Labor painBefore initiation of epidural ,10 ,30,45,60 min after initiation then every 1hour till the delivery of the fetusLabour pain measured by Visual analogue
Motor blockBefore initiation of epidural ,10 ,30,45,60 min after initiation then every 1hour till the delivery of the fetusMotor block measured by bromage scsle
Delivery typeAt time of fetus deliveryDelivery type spontaneous or instrument
Maternal satisfactionPreoperative,2nd stage of labour, third stage of labour and immediately after delivery, 2 hours after delivery,4 hours after delivery,12 hours after deliverySatisfied or not
ComplicationsPreoperative,2nd stage of labour, third stage of labour and immediately after delivery, 2 hours after delivery,4 hours after delivery,12 hours after deliveryAny complications detected

Countries

Egypt

Contacts

CONTACTRabab Habeeb, MD
rabab_habeeb@med.menofia.edu.eg+201001970973

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026