The Effect of Adding Nalbuphine to Intrathecal Morphine on Analgesic Efficacy and Side Effects After Cesarean Section

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Post-cesarean Section Analgesic Potency and Side Effects of Intrathecal Morphine and Nalbuphine

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Morphine
* Drug: Morphine plus Nalbuphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients age between 16 to 40 years ASA physical status I - II Exclusion Criteria: Infection at the site of injection. Coagulopathy or other bleeding diathesis. Preexisting neurologic deficits. History of hypersensitivity to any of the given the drugs. Inability to communicate with the investigator and the hospital staff. History of chronic opioid us

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Morphine group | Drug: Morphine<br>* 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.<br>* Other names: Infumorph;|
| Active Comparator: Group 2<br>Morphine plus Nalbuphine group | Drug: Morphine plus Nalbuphine<br>* 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.<br>* Other names: Infumorph and NALUFIN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Visual Analogue Score | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative itching | Visual Analogue Score | 24 hours | 
| number of participants with incidence of postoperative nausea | Patients number | 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 |