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

Primary Purpose

Post-operative Pain

Status
Unknown status
Phase
Phase 4
Locations
Malaysia
Study Type
Interventional
Intervention
morphine
Patient re-education
Sponsored by
Clinical Research Centre, Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain focused on measuring IV-Patient Controlled Analgesia (IV-PCA), background morphine infusion, patient re-education

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sultanah Bahiyah HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Background morphine infusion to IV-PCA Morphine

Patient re-education to IV-PCA Morphine

Arm Description

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

Using patient information leaflet

Outcomes

Primary Outcome Measures

measure pain intensity at rest and when blowing incentive spirometer (dynamic pain)
use combination of Numerical Rating Scale(NRS) and Visual Analogue Scale(VAS)

Secondary Outcome Measures

respiratory rate
total accumulative morphine consumption from IV-PCA pump
sedation level
sedation score (0 to 3)

Full Information

First Posted
August 10, 2015
Last Updated
August 14, 2015
Sponsor
Clinical Research Centre, Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT02523846
Brief Title
Patient Re-education vs. Background Morphine to IV-PCA in Patient With Unsatisfactory Analgesia Post Laparotomy
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 Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Research Centre, Malaysia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain
Keywords
IV-Patient Controlled Analgesia (IV-PCA), background morphine infusion, patient re-education

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Background morphine infusion to IV-PCA Morphine
Arm Type
Active Comparator
Arm Description
Calculate based on patient's age, in mg/hour
Arm Title
Patient re-education to IV-PCA Morphine
Arm Type
Experimental
Arm Description
Using patient information leaflet
Intervention Type
Drug
Intervention Name(s)
morphine
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Patient re-education
Intervention Description
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
Primary Outcome Measure Information:
Title
measure pain intensity at rest and when blowing incentive spirometer (dynamic pain)
Description
use combination of Numerical Rating Scale(NRS) and Visual Analogue Scale(VAS)
Time Frame
48 hours after surgery
Secondary Outcome Measure Information:
Title
respiratory rate
Time Frame
48 hours after surgery
Title
total accumulative morphine consumption from IV-PCA pump
Time Frame
48 hours after surgery
Title
sedation level
Description
sedation score (0 to 3)
Time Frame
48 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lee Choo Yeoh, Master
Phone
047722625
Email
yeohlc55@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
lee choo yeoh, master
Organizational Affiliation
CRC Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sultanah Bahiyah Hospital
City
Alor Seatr
State/Province
Kedah
ZIP/Postal Code
05050
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yeoh lc
Phone
047722625
Email
yeohlc55@yahoo.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
8740614
Citation
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.
Results Reference
result

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

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