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To evaluate the efficacy and safety of dexmedetomidine as an adjuvant to bupivacain and fentanyl in spinal Analgesia to decreases pain during normal labour
Effect of adding dexmedetomidine to bupivacain fentanyl mixture in spinal analgesia for normal labour
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEX | Active Comparator | Participants receive intrathecaliy hyperbaric bupivacaine 2.5 mg (0.5 mL) combined with dexmedetomidine 2.5 µg and fentanyl 25 µg, diluted to a total volume of 2.5 mL. The solution will be administered as a single spinal injection under aseptic conditions. |
|
| CONTROLLED | Active Comparator | Participants will receive intrathecaliy hyperbaric bupivacaine 2.5 mg (0.5 mL) combined with fentanyl 25 µg, diluted to a total volume of 2.5 mL. The solution will be administered as a single spinal injection under aseptic conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injecting dexmedetomidine | Drug | injecting dexmedetomidine intrathecally during labour pain |
| |
| Measure | Description | Time Frame |
|---|---|---|
| changes in numeric pain intensity score ( NPSI) maximum 10 minimum 0 | evaluate the safety and effecacy of dexmetomidine for labour pain by numeric pain intensity score maximum 10 ( sever pain ), minimum 0 ( no pain ) | baseline |
| duration of sensory blockade | change in numeric pain intensity score ( NPIS ) | 5 minutes after injection of analgesic agents till normal delivery done |
| changes in numeric pain intensity score ( NPIS ) | Scores range from 0-10 points, maximum ( 10 ) means sever pain, minimum ( 0 ) means no pain | 5 minutes, 10 minutes, 15 minutes, 30 minutes and 45 minintes after injection of analgesic agents |
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Inclusion Criteria:
Age of patint is between 18 and 40 years. gestational age of fetus is more than 37 weeks. singleton viable fetus and cephalic presentation. spontaneous labor with cervix dilation more than 5cm.
Exclusion Criteria:
Drug allergy. Blood Disease. Infection at site of injection. patient takes anticoagulants. patient has pre-eclampsia ,cardiac disease (NYHA III-IV) or diabetes mellitus type I prior to the pregnancy patients refuse
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Ragab, Master | Contact | 086-01001737436 | mohamedragab2209@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed Ragab, master | Minia University Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minya | Minya | 61915 | Egypt |
|
all collected IPD,
december 2025 - december 2026
labour analgesia
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effect of adding dexmetomidine to bupivcain fentanyl mixture in spinal analgesia for normal labour
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Masking Description
| injecting mixture of bupivacaine fentanyl |
| Drug |
injecting mixture of bupivacaine fentanyl intrathecally |
|