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This study is designed to see the effect of low dose intrathecal morphine on promting enhanced recovery after cesarean delivery with early ambulation and reduction of hospital stay.
Parturients showing for elective cesarean section will be randomized into 3 groups by a computer generated randomization list. Each randomization slip will be put in a sealed envelope until patient enrollment. Patients will be divided into Group C: control group, given intrathecal bupivacaine 12.5 mg. Group M25: intrathecal bupivacaine 12.5mg + morphine 25 microgram. Group M50: intrathecal bupivacaine 12.5mg + morphine 50 microgram.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group C | Placebo Comparator | given intrathecal bupivacaine 12.5 mg. |
|
| Group M25 | Active Comparator | given intrathecal bupivacaine 12.5mg + morphine 25 microgram. |
|
| Group M50 | Active Comparator | given intrathecal bupivacaine 12.5mg + morphine 50 microgram. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine Sulfate | Drug | intrathecal low dose morphine for early return to normal activity without opioid related complications. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain postoperative | postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain | 2 hours postoperatively |
| Pain postoperative | postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain | 4 hours postoperatively |
| Pain postoperative | postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain | 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| vomiting | four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting). | 2 hours postoperative |
| vomiting | four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting). |
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Inclusion Criteria:
Exclusion Criteria:
females presenting for cesarean section
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sohair A Megalla, MD | Contact | +20 120 003 6447 | Sohair.Adeeb@minia.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Sohair A Megalla, MD | Anesthesia and ICU department, Faculty of Medicine, Minia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minia university | Recruiting | Minya | Egypt |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D011537 | Pruritus |
| D020250 | Postoperative Nausea and Vomiting |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Bupivacaine Hydrochloride | Drug | intrathecal bupivacaine 0.5% |
|
|
| 4 hours postoperative |
| vomiting | four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting). | 24 hours postoperative |
| itching | four-point rating score (1: no itching, 2: mild,face, no traetment needed 3: severe itching, allover the body). | 2 hours postoperative |
| itching | four-point rating score (1: no itching, 2: mild,face, no traetment needed 3: severe itching, allover the body). | 4 hours postoperative |
| itching | four-point rating score (1: no itching, 2: mild,face, no traetment needed 3: severe itching, allover the body). | 24 hours postoperative |
| respiratory depression | respiratory rate less than 8 breaths \ minute | 4 hours postoperative |
| D012816 | Signs and Symptoms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |