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This study aims at evaluating the effect of adding magnesium sulphate epidurally as an adjunct to levobupivacaine on the quality of anesthesia and perioperative pain relief in patients with preeclampsia undergoing elective caesarian section (CS).
Pregnant women with preeclampsia undergoing elective CS in will be included in the study. All patients participating in the study will be randomly divided into two groups; magnesium sulphate group (study group) and placebo group (control group). Patients in the study group will receive epidural 20 ml levobupivacaine hydrochloride 0.5% plus 5 ml magnesium sulphate 10% (500 mg) while patients in the control group will received epidural 20 ml levobupivacaine hydrochloride 0.5% plus 5 ml saline 0.9%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium sulphate group | Active Comparator | Patients will receive epidural levobupivacaine hydrochloride + magnesium sulphate |
|
| Placebo group | Placebo Comparator | Patients will receive epidural levobupivacaine hydrochloride + saline 0.9% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levobupivacaine hydrochloride | Drug | Patients will receive epidural 20 ml levobupivacaine hydrochloride 0.5% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain-free period | The time from reaching sensory block to onset of pain | 24 hours after the epidural anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tamer Elmetwally, Dr | Mansoura University | Principal Investigator |
| Mohamed S Abdelhafez, Dr | Mansoura University | Study Director |
| Reem A Elsharkawy, Dr | Mansoura University | Study Director |
| Waleed El-refaie, Dr | Mansoura University | Study Director |
| Alaa Wageeh, Dr | Mansoura University | Study Director |
| Salwa S Hays, Prof | Mansoura University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University Hospital | Al Mansurah | Dakahlia Governorate | 35111 | Egypt |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| D008278 | Magnesium Sulfate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Magnesium sulphate | Drug | Patients will receive epidural 5 ml magnesium sulphate 10% |
|
| Saline 0.9% | Drug | Patients will receive epidural 5 ml saline 0.9% |
|
| Aniline Compounds |
| D000588 | Amines |
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D017670 | Sodium Compounds |