The Effect of Different Doses of Dexmedetomidine as an Adjuvant to Bupivacaine for Parturients Having Dural Puncture Epidural Technique to Elaborate Labor Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Menoufia University
- Enrollment
- 140
- Locations
- 2
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Epidural puncture with dexmedetomidine 0.4 (Bup/DEX0.6 )
Combined epidural with epidural puncture using bupivacaine plus dexmetomedine0.4
Intervention: Dexmedetomidine 0.4 added (Drug)
Epidural puncture with dexmedetomidine 0.6 (Bup/DEX0.6 )
Combined epidural with epidural puncture using bupivacaine plus dexmetomedine0.6
Intervention: Epidural Catheter with bupivacaine (Device)
Epidural puncture with dexmedetomidine 0.6 (Bup/DEX0.6 )
Combined epidural with epidural puncture using bupivacaine plus dexmetomedine0.6
Intervention: Epidural with dural puncture (Device)
Epidural puncture with dexmedetomidine 0.6 (Bup/DEX0.6 )
Combined epidural with epidural puncture using bupivacaine plus dexmetomedine0.6
Intervention: Dexmedetomidine 0.6 added (Drug)
Epidural group with bupivacaine CE
Epidural with plain bupivacaine DPE
Intervention: Epidural Catheter with bupivacaine (Device)
Epidural puncture with bupivacaine
Combined epidural with epidural puncture using bupivacaine
Intervention: Epidural Catheter with bupivacaine (Device)
Epidural puncture with bupivacaine
Combined epidural with epidural puncture using bupivacaine
Intervention: Epidural with dural puncture (Device)
Epidural puncture with dexmedetomidine 0.4 (Bup/DEX0.6 )
Combined epidural with epidural puncture using bupivacaine plus dexmetomedine0.4
Intervention: Epidural Catheter with bupivacaine (Device)
Epidural puncture with dexmedetomidine 0.4 (Bup/DEX0.6 )
Combined epidural with epidural puncture using bupivacaine plus dexmetomedine0.4
Intervention: Epidural with dural puncture (Device)
Investigators
rabab Mohammad habeeb
Principle investigator
Menoufia University