Faculty of Medicine Menoufia University
Shebeen El Kom, 32511, Egypt
Not Yet Recruiting
NCT Number: NCT07506044
Dexmedetomidine as an Adjuvant During Dural Puncture Epidural
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Age range
18 year–40 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Epidural Catheter with bupivacaine
Deviceepidural injection of plain Bup
Epidural with dural puncture
Devicethe dura is punctured by a 26-G spinal needle using the needle-through-needle technique, and is withdrawn after confirmation of free-flowing cerebrospinal fluid,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 added
DrugDexmedetomidine 0.4 added
Dexmedetomidine 0.6 added
DrugDexmedetomidine 0.6 added
Primary outcomes
-
Total dose of bupivacaine
Time frame: From the induction of epidural to the delivery of the fetus
Total dose of bupivacaine administered
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
Labour pain measured by Visual analogue
-
Motor block
Time frame: Before initiation of epidural ,10 ,30,45,60 min after initiation then every 1hour till the delivery of the fetus
Motor block measured by bromage scsle
-
Delivery type
Time frame: At time of fetus delivery
Delivery type spontaneous or instrument
-
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
Satisfied or not
-
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
Any complications detected
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Menoufia University
Other
Registry information
Official study title
The Effect of Different Doses of Dexmedetomidine as an Adjuvant to Bupivacaine for Parturients Having Dural Puncture Epidural Technique to Elaborate Labor Pain
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Apr 1, 2026
- Registry last updated
- Jun 2, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.