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Central neuraxial analgesia has been extensively used for labor analgesia and is currently the gold standard technique for pain control in obstetrics.
The aim of the study will be to compare the role of dexmedetomidine or fentanyl as additives to epidural levobupivacaine in painless vaginal delivery as regard maternal analgesia and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group C (Control group) | Active Comparator | pidural analgesia with levobupivacaine alone |
|
| Group D (Dexmedetomidine group) | Experimental | Epidural analgesia with levobupivacaine and dexmedetomidine |
|
| Group F (Fentanyl group) | Experimental | Epidural analgesia with levobupivacaine and fentanyl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levobupivacaine | Drug | The patients will receive 15 ml of 0.125% levobupivacaine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of maternal analgesia | Duration of analgesia will be assessed by measuring the time between the onset of sensory block and return of pain sensation. If the block is inadequate or the patient has pain, a top up dose of 8 mL of the study medication and local anesthetic will be given when visual analogue scale (VAS) will be ≥ 4. The pain relief will be assessed by the visual analogue scale (VAS) from 0 to 10 (0: no pain, 1-3: mild pain, 4-7: moderate pain, > 7: severe pain). | 24 hours after epidural injection |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of maternal analgesia. | The onset of analgesia will be defined as the time taken from drug administration to visual analogue scale (VAS) <3. | One hour after epidural injection |
| Complications of drugs of epidural technique |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University Hospitals | Tanta | Gharbia Governorate | 31527 | Egypt |
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| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| D020927 | Dexmedetomidine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Patients will be randomly allocated into three equal groups by computer generated sequence through sealed opaque envelopes. Each group will include 30 patients.
Group C (Control group): Epidural analgesia with levobupivacaine alone Group D (Dexmedetomidine group): Epidural analgesia with levobupivacaine and dexmedetomidine Group F (Fentanyl group): Epidural analgesia with levobupivacaine and fentanyl
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| Dexmedetomidine | Drug | The patients will receive 13 ml of 0.125% levobupivacaine and 0.5μg/kg dexmedetomidine diluted in 2 ml saline. |
|
| Fentanyl | Drug | The patients will receive 13 ml of 0.125% levobupivacaine and 25μg fentanyl diluted in 2 ml saline. |
|
Drugs: Sedation, Bradycardia Epidural anesthesia (including nausea, vomiting, backache and fever)
| 24 hours after epidural injection |
| Aniline Compounds |
| D000588 | Amines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |