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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural group with bupivacaine CE | Active Comparator | Epidural with plain bupivacaine DPE |
|
| Epidural puncture with bupivacaine | Active Comparator | Combined epidural with epidural puncture using bupivacaine |
|
| Epidural puncture with dexmedetomidine 0.4 (Bup/DEX0.6 ) | Active Comparator | Combined epidural with epidural puncture using bupivacaine plus dexmetomedine0.4 |
|
| Epidural puncture with dexmedetomidine 0.6 (Bup/DEX0.6 ) | Active Comparator | Combined epidural with epidural puncture using bupivacaine plus dexmetomedine0.6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural Catheter with bupivacaine | Device | epidural injection of plain Bup |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total dose of bupivacaine | Total dose of bupivacaine administered | From the induction of epidural to the delivery of the fetus |
| Measure | Description | Time Frame |
|---|---|---|
| Labor pain | Labour pain measured by Visual analogue | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Abnormal fetal presentation or lie, 'premature rupture of membranes, maternal fever, fetal distress, pregnancy-induced diseases
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rabab Habeeb, MD | Contact | +201001970973 | rabab_habeeb@med.menofia.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Menoufia University | Shebeen El Kom | 32511 | Egypt |
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| ID | Term |
|---|---|
| D007268 | Injections, Epidural |
| ID | Term |
|---|---|
| D007278 | Injections, Spinal |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
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| 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 |
|
| 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 | At time of fetus delivery |
| Maternal satisfaction | Satisfied or not | 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 | 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 |
| D013812 |
| Therapeutics |