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Intrathecal morphine causes intense itching which is very bothersome. Nalbuphine antagonizes this effect when given intravenously. This trial is to find out if nalbuphine added to intrathecal morphine has an effect on morphine related pruritus while still maintaining adequate analgesia.
The study will be performed in MiniaUniversity Hospitals, after obtaining approval from the local ethics committee. All patients will have a peripheral IV cannula 18 G inserted; standard non-invasive monitors will be applied. Patients undergoing major abdominal surgery will be divided into 2 groups to receive intrathecal morphine 300 micrograms with or without nalbuphine 1mg prior to anesthesia. General anesthesia is then given to patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MN group | Active Comparator | intrathecal morphine 300 micrograms+2mg nalbuphine |
|
| M group | Placebo Comparator | intrathecal morphine 300 micrograms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine 10 MG/ML | Drug | intrathecal morphine 300 micrograms |
|
| Measure | Description | Time Frame |
|---|---|---|
| pruritus | Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus). | 2 hours postoperatively |
| pruritus | Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus). | 4 hours postoperatively |
| pruritus | Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus). | 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain | assessed with a verbal numeric pain score(NRS) where 0: no pain; 10: worst imaginable pain | 2 hours postoperative |
| postoperative pain | assessed with a verbal numeric pain score(NRS) where 0: no pain; 10: worst imaginable pain |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| anesthesia&ICU department | Recruiting | Minya | Egypt |
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| ID | Term |
|---|---|
| D011537 | Pruritus |
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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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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| Nalbuphine Hydrochloride 10 MG/ML | Drug | intrathecal nalbuphine 2mg. |
|
|
| 4 hours postoperative |
| postoperative pain | assessed with a verbal numeric pain score(NRS) where 0: no pain; 10: worst imaginable pain | 24 hours postoperative |
| postoperative nausea and vomiting | four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting | 2 hours postoperative |
| postoperative nausea and vomiting | four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting | 4 hours postoperative |
| postoperative nausea and vomiting | four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting | 24 hours postoperative |
| Sedation | four-point sedation score (1: fully awake; 2: somnolent, responds to call; 3: somnolent, responds to tactile stimulation; 4: asleep, responds to painful stimulation). | 2 hours postoperative |
| Sedation | four-point sedation score (1: fully awake; 2: somnolent, responds to call; 3: somnolent, responds to tactile stimulation; 4: asleep, responds to painful stimulation). | 4 hours postoperative |
| Sedation | four-point sedation score (1: fully awake; 2: somnolent, responds to call; 3: somnolent, responds to tactile stimulation; 4: asleep, responds to painful stimulation). | 24 hours postoperative |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic 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 |