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

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.

Study Overview

• Status: Unknown
• Conditions: Post-operative Pain
• Intervention / Treatment: Drug: morphine; Behavioral: Patient re-education

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lee Choo Yeoh, Master; Phone Number: 047722625; Email: yeohlc55@yahoo.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Background morphine infusion to IV-PCA Morphine; Calculate based on patient's age, in mg/hour	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
Experimental: Patient re-education to IV-PCA Morphine; Using patient information leaflet	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Clinical Research Centre, Malaysia
• Investigators: Principal Investigator: lee choo yeoh, master, CRC Malaysia

Publications and helpful links

General Publications

• Macintyre PE, Jarvis DA. Age is the best predictor of postoperative morphine requirements. Pain. 1996 Feb;64(2):357-364. doi: 10.1016/0304-3959(95)00128-X.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: August 10, 2015
• First Submitted That Met QC Criteria: August 13, 2015
• First Posted (Estimate): August 14, 2015

Study Record Updates

• Last Update Posted (Estimate): August 17, 2015
• Last Update Submitted That Met QC Criteria: August 14, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: IV-Patient Controlled Analgesia (IV-PCA); background morphine infusion; patient re-education
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: 20790