Trial | NCT02523846  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    morphine ...

  • Study Participants

    160
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.
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".
Study Started
Aug 31
2015
Primary Completion
Jul 31
2016
Anticipated
Last Update
Aug 17
2015
Estimate

Drug morphine

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)

Behavioral Patient re-education

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

Background morphine infusion to IV-PCA Morphine Active Comparator

Calculate based on patient's age, in mg/hour

Patient re-education to IV-PCA Morphine Experimental

Using patient information leaflet

Criteria 

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
No Results Posted