Dexmedetomidine as an Adjuvant During Dural Puncture Epidural

Menoufia University

Status: Not yet enrolling

Conditions: Total Dose of Bupivacaine Administered During Labor

Treatments: Drug: Dexmedetomidine 0.6 added; Device: Epidural Catheter with bupivacaine; Device: Epidural with dural puncture; Drug: Dexmedetomidine 0.4 added

Study type: Interventional

Funder types: Other

Identifiers

NCT07506044

2/2026ANET2-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 4 patient groups

Epidural group with bupivacaine CE

Active Comparator group

Description:

Epidural with plain bupivacaine DPE

Treatment:

Device: Epidural Catheter with bupivacaine

Epidural puncture with bupivacaine

Active Comparator group

Description:

Combined epidural with epidural puncture using bupivacaine

Treatment:

Device: Epidural with dural puncture

Device: Epidural Catheter with bupivacaine

Epidural puncture with dexmedetomidine 0.4 (Bup/DEX0.6 )

Active Comparator group

Description:

Combined epidural with epidural puncture using bupivacaine plus dexmetomedine0.4

Treatment:

Drug: Dexmedetomidine 0.4 added

Device: Epidural with dural puncture

Device: Epidural Catheter with bupivacaine

Epidural puncture with dexmedetomidine 0.6 (Bup/DEX0.6 )

Active Comparator group

Description:

Combined epidural with epidural puncture using bupivacaine plus dexmetomedine0.6

Treatment:

Device: Epidural with dural puncture

Device: Epidural Catheter with bupivacaine

Drug: Dexmedetomidine 0.6 added