UnknownPhase 4

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

Malaysia160 participantsStarted 2015-08

Plain-language 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.

Who can participate

Age range

20 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

measure pain intensity at rest and when blowing incentive spirometer (dynamic pain)

Timeframe: 48 hours after surgery

Trial details

NCT IDNCT02523846

SponsorClinical Research Centre, Malaysia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-07

Contact for this trial

Lee Choo Yeoh, Master

047722625 yeohlc55@yahoo.com

View on ClinicalTrials.gov More Post-operative Pain trials