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

Phase 4

• Conditions: Post-operative Pain
• Interventions: Drug: morphine; Behavioral: Patient re-education

• Registration Number: NCT02523846
• Lead Sponsor: Clinical Research Centre, Malaysia

Brief Summary

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

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 Timeline

• Status Verified: 2015-08
• Study Start: 2015-08
• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-08-13
• Study First Posted: 2015-08-14
• Last Update Submitted: 2015-08-14
• Last Update Posted: 2015-08-17
• Primary Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Background morphine infusion to IV-PCA Morphine	Patient re-education	Calculate based on patient's age, in mg/hour
Patient re-education to IV-PCA Morphine	Patient re-education	Using patient information leaflet
Background morphine infusion to IV-PCA Morphine	morphine	Calculate based on patient's age, in mg/hour

Primary Outcome Measures

Name	Time	Method
measure pain intensity at rest and when blowing incentive spirometer (dynamic pain)	48 hours after surgery	use combination of Numerical Rating Scale(NRS) and Visual Analogue Scale(VAS)

Secondary Outcome Measures

Name	Time	Method
respiratory rate	48 hours after surgery
total accumulative morphine consumption from IV-PCA pump	48 hours after surgery
sedation level	48 hours after surgery	sedation score (0 to 3)

Trial Locations

Locations (1)

Sultanah Bahiyah Hospital; 🇲🇾 Alor Seatr, Kedah, Malaysia