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

Information source: Clinical Research Centre, Malaysia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post-operative Pain

Intervention: morphine (Drug); Patient re-education (Behavioral)

Phase: Phase 4

Status: Recruiting

Sponsored by: Clinical Research Centre, Malaysia

Official(s) and/or principal investigator(s):
lee choo yeoh, master, Principal Investigator, Affiliation: CRC Malaysia

Overall contact:
Lee Choo Yeoh, Master, Phone: 047722625, Email: yeohlc55@yahoo.com


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Secondary outcome:

respiratory rate

total accumulative morphine consumption from IV-PCA pump

sedation level

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".


Minimum age: 20 Years. Maximum age: 70 Years. Gender(s): Both.


Inclusion Criteria:

- American Society of Anesthesiologists (ASA)Physical Status Classification Class I and


- 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

Locations and Contacts

Lee Choo Yeoh, Master, Phone: 047722625, Email: yeohlc55@yahoo.com

Sultanah Bahiyah Hospital, Alor Seatr, Kedah 05050, Malaysia; Recruiting
yeoh lc, Phone: 047722625, Email: yeohlc55@yahoo.com
Additional Information

Starting date: August 2015
Last updated: August 14, 2015

Page last updated: August 23, 2015

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