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Dexmedetomidine as an Adjuvant During Dural Puncture Epidural

ConditionTotal Dose of Bupivacaine Administered During Labor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorMenoufia University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

abnormal placental position,

ASA grade>II

marked obesity,

allergy or contraindications to the used drugs,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Epidural Catheter with bupivacaine

    Device

    epidural injection of plain Bup

  • Epidural with dural puncture

    Device

    the dura is punctured by a 26-G spinal needle using the needle-through-needle technique, and is withdrawn after confirmation of free-flowing cerebrospinal fluid,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

    Drug

    Dexmedetomidine 0.4 added

  • Dexmedetomidine 0.6 added

    Drug

    Dexmedetomidine 0.6 added

Treatment groups

140 Participants
are divided into 4 treatment groups
Group A: Epidural group with bupivacaine CEActive comparator 1 intervention
Group B: Epidural puncture with bupivacaineActive comparator 2 interventions
Group C: Epidural puncture with dexmedetomidine 0.4 (Bup/DEX0.6 )Active comparator 3 interventions
Group D: Epidural puncture with dexmedetomidine 0.6 (Bup/DEX0.6 )Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

Total dose of bupivacaine

Total dose of bupivacaine administered

Time frame
From the induction of epidural to the delivery of the fetus

Secondary outcomes

1

Labor pain

Labour pain measured by Visual analogue

Time frame
Before initiation of epidural ,10 ,30,45,60 min after initiation then every 1hour till the delivery of the fetus
2

Motor block

Motor block measured by bromage scsle

Time frame
Before initiation of epidural ,10 ,30,45,60 min after initiation then every 1hour till the delivery of the fetus
3

Delivery type

Delivery type spontaneous or instrument

Time frame
At time of fetus delivery
4

Maternal satisfaction

Satisfied or not

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

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Faculty of Medicine Menoufia UniversityRecruiting32511, Shebeen El KomEgyptEgypt

Sponsors and contacts

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Menoufia University

Lead sponsor

Source ClinicalTrials.gov
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