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The primary endpoint of this study is to investigate the effect of adding nalbuphine to intrathecal morphine on quality of postoperative analgesia and Morphine related side effects post- cesarean delivery.
The study will be performed in Assiut University Hospitals, after obtaining approval from the local ethics committee and written informed patient consent. All patients will have a peripheral IV cannula 18 G inserted; standard non-invasive monitors will be applied. All the patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous. Intrathecal block under strict aseptic conditions will be performed in sitting position at L3-4 or L4-5 inter-spinous space with 25G pencil-point spinal needle. All patients will receive intrathecal 10 mg of 0.5% hyperbaric bupivacaine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Morphine group |
|
| Group 2 | Active Comparator | Morphine plus Nalbuphine group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine | Drug | 38 patients of this group will receive 10 mg of 0.5% hyperbaric bupivacaine (Buvanest Spinal 0.5% Heavy) with 0.2 mg morphine (Infumorph - Injection 10 mg/mL) in 0.5 ml volume (total volume 2.5 mL). Patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Visual Analogue Score | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative itching | Visual Analogue Score | 24 hours |
| number of participants with incidence of postoperative nausea | Patients number |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abdelrady S Ibrahim, MD | Assistant professor of anesthesia and intensive care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut university faculty of medicine | Asyut | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10960384 | Background | Culebras X, Gaggero G, Zatloukal J, Kern C, Marti RA. Advantages of intrathecal nalbuphine, compared with intrathecal morphine, after cesarean delivery: an evaluation of postoperative analgesia and adverse effects. Anesth Analg. 2000 Sep;91(3):601-5. doi: 10.1097/00000539-200009000-00019. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D009266 | Nalbuphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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|
|
| Morphine plus Nalbuphine | Drug | 39 patients of this group will receive 10 mg of 0.5% hyperbaric bupivacaine (Buvanest Spinal 0.5% Heavy) with 0.5 mg morphine (Infumorph - Injection 10 mg/mL) plus 0.2 mg nalbuphine (NALUFIN 20MG/ML AMP) in 0.5 ml volume (total volume 2.5 mL). Patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous. |
|
|
| 24 hours |
| number of participants with incidence of postoperative vomiting | Patients number | 24 hours |
| number of participants with incidence of postoperative postdural puncture headache | Patients number | 24 hours |
| number of participants with incidence of postoperative respiratory depression | Patients number | 24 hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| 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 |