Dexmedetomidine as an Adjuvant During Dural Puncture Epidural
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Epidural Catheter with bupivacaine, Epidural with dural puncture, Dexmedetomidine 0.4 added, Dexmedetomidine 0.6 added.
- Who it may be relevant to
- Registry conditions: Total Dose of Bupivacaine Administered During Labor. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Device Epidural Catheter with bupivacaine
epidural injection of plain Bup - Device Epidural 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the dura is punctured by a 26-G spinal needle using the needle-through-needle technique, and is withdrawn after confirmation of free-flowing cerebrospinal fluid, - Drug Dexmedetomidine 0.4 added
Dexmedetomidine 0.4 added - Drug Dexmedetomidine 0.6 added
Dexmedetomidine 0.6 added
Primary outcome measures
- Total dose of bupivacaine [Time frame: From the induction of epidural to the delivery of the fetus]
Secondary outcome measures (5)
- 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]
Eligibility criteria
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 exclusion criteria
Exclusion criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Medicine Menoufia University — Shebeen El Kom
Identifiers
NCT: NCT07506044 · 2/2026ANET2-1