Patient Re-education vs. Background Morphine to IV-PCA in Patient With Unsatisfactory Analgesia Post Laparotomy

Study Overview
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Brief Summary
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The purpose of this study is to improve IV-Patient Controlled Analgesia (IV-PCA) technique for postoperative analgesia. Investigators are comparing between patient re-education and the background morphine infusion among patients who fail to achieve satisfactory analgesia using IV-PCA Morphine after laparotomy.

Detailed Description
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In this study, investigators have a second inclusion criteria for subject recruitment. For subjects who meet this criteria meaning their dynamic pain (when blowing incentive spirometer) is ≥ 4/10 after starting on IV-PCA Morphine will be randomized in to 2 groups. One group will receive patient re--education with an additional background morphine infusion and the other group will receive re--education only. The second highlight for this study is regarding the background morphine calculation. The background morphine is calculated according to this formula: Total morphine requirement in the first 24 hours post surgery (mg) = 100 - Age (year) So, the background morphine infusion will be calculated based on subject's age and half of their 24 hours requirement will be infused over 24 hours. This formula was published by Pamela Macintyre in her paper titled  Age is the Best Predictor of Postoperative Morphine Requirement.

Official Title
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Comparing Effectiveness of Post-operative Analgesia Between Patient Re-education and the Additional of a Basal Morphine Infusion to IV-PCA Morphine in Patients With Unsatisfactory Analgesia After Laparotomy

Conditions
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Post-operative Pain

Intervention / Treatment
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* Drug: morphine
* Behavioral: Patient re-education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA)Physical Status Classification Class I and II Elective laparotomy able to understand either malaysia, mandarin, english language or local dialect patient with dynamic pain score 4/10 and more within the first 4-hour after initiation of IV-PCA Exclusion Criteria: patient refusal laparotomy with pfannenstiel incision patients with a history of allergy to opioids patients who required post-operative ventilation support patients ASA III and above patients unable to use PCA due to insufficient comprehension morbid obesity/ obstructive sleep apnea chronic opioid or alcohol abuse

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Background morphine infusion to IV-PCA Morphine<br>Calculate based on patient's age, in mg/hour | Drug: morphine<br>* Investigators use the formula that was published by Pamela Macintyre in her paper entitled Age is the Best Predictor of Postoperative Morphine Requirements. The estimation for the first 24-hour morphine requirement after surgery is calculated as: 100 - age (year). So, half of the total 24-hour morphine requirement will be infused over 24 hours. e.g. background morphine infusion= (100-Age)/ 2/ 24 (mg/hour)<br>Behavioral: Patient re-education<br>* A similar leaflet will be used to re-educate patient at 4 hour after surgery. The correct method to initiate IV-PCA dose, possible side effects and addiction issue will be explained again and re-emphasized<br>|
| Experimental: Patient re-education to IV-PCA Morphine<br>Using patient information leaflet | Behavioral: Patient re-education<br>* A similar leaflet will be used to re-educate patient at 4 hour after surgery. The correct method to initiate IV-PCA dose, possible side effects and addiction issue will be explained again and re-emphasized<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure pain intensity at rest and when blowing incentive spirometer (dynamic pain) | use combination of Numerical Rating Scale(NRS) and Visual Analogue Scale(VAS) | 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory rate |  | 48 hours after surgery | 
| total accumulative morphine consumption from IV-PCA pump |  | 48 hours after surgery | 
| sedation level | sedation score (0 to 3) | 48 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IV-Patient Controlled Analgesia (IV-PCA), background morphine infusion, patient re-education