Adding Nalbuphine for Control of Intrathecal Morphine Pruritus

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Does Adding Nalbuphine to Intrathecal Morphine Reduce Morphine Induced Pruritus? A Randomized, Double Blind, Controlled Study.

Conditions
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Pruritus, Pain, Postoperative, Nausea, Postoperative, Vomiting, Postoperative

Intervention / Treatment
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* Drug: Morphine 10 MG/ML
* Drug: Nalbuphine Hydrochloride 10 MG/ML


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients. Age 18-80yrs. Elective major abdominal surgery under general anesthesia. Exclusion Criteria: Refusal to participate. Skin or systemic disease with itching. Any condition which precludes performing spinal injection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MN group<br>intrathecal morphine 300 micrograms+2mg nalbuphine | Drug: Morphine 10 MG/ML<br>* intrathecal morphine 300 micrograms<br>* Other names: morphine;Drug: Nalbuphine Hydrochloride 10 MG/ML<br>* intrathecal nalbuphine 2mg.<br>* Other names: nalbuphine;|
| Placebo Comparator: M group<br>intrathecal morphine 300 micrograms | Drug: Morphine 10 MG/ML<br>* intrathecal morphine 300 micrograms<br>* Other names: morphine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pruritus, intrathecal morphine, intrathecal nalbuphine