Dexmedetomidine as an Adjuvant During Dural Puncture Epidural

Menoufia University140 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

140

Conditions

Total Dose of Bupivacaine Administered During Labor

Interventions

Epidural Catheter with bupivacaineDEVICE

epidural injection of plain Bup

Epidural with dural punctureDEVICE

the dura is punctured by a 26-G spinal needle using the needle-through-needle technique, and is withdrawn after confirmation of free-flowing cerebrospinal fluid,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

Dexmedetomidine 0.4 added

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Medicine Menoufia University

Shebeen El Kom, Egypt

RECRUITING

Outcomes

Primary Outcomes

Total dose of bupivacaine

Total dose of bupivacaine administered

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

Secondary Outcomes

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

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

Delivery type

Delivery type spontaneous or instrument

Time frame: At time of fetus delivery

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

Complications

Any complications detected

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

Central Contacts

Rabab Habeeb, MD

CONTACT

+201001970973 rabab_habeeb@med.menofia.edu.eg

Data from ClinicalTrials.gov

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