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

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ClinicalTrials.gov Identifier: NCT02523846
Recruitment Status : Unknown
Verified August 2015 by Yeoh Lee Choo, Clinical Research Centre, Malaysia.
Recruitment status was:  Recruiting
First Posted : August 14, 2015
Last Update Posted : August 17, 2015
Sponsor:
Information provided by (Responsible Party):
Yeoh Lee Choo, 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.

Condition or disease Intervention/treatment Phase
Post-operative Pain Drug: morphine Behavioral: Patient re-education Phase 4

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".

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2015
Estimated Primary Completion Date : July 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. measure pain intensity at rest and when blowing incentive spirometer (dynamic pain) [ Time Frame: 48 hours after surgery ]
    use combination of Numerical Rating Scale(NRS) and Visual Analogue Scale(VAS)


Secondary Outcome Measures :
  1. respiratory rate [ Time Frame: 48 hours after surgery ]
  2. total accumulative morphine consumption from IV-PCA pump [ Time Frame: 48 hours after surgery ]
  3. sedation level [ Time Frame: 48 hours after surgery ]
    sedation score (0 to 3)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02523846


Contacts
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Contact: Lee Choo Yeoh, Master 047722625 yeohlc55@yahoo.com

Locations
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Malaysia
Sultanah Bahiyah Hospital Recruiting
Alor Seatr, Kedah, Malaysia, 05050
Contact: yeoh lc    047722625    yeohlc55@yahoo.com   
Sponsors and Collaborators
Clinical Research Centre, Malaysia
Investigators
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Principal Investigator: lee choo yeoh, master CRC Malaysia

Publications of Results:
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Responsible Party: Yeoh Lee Choo, Anaesthesiologist, Clinical Research Centre, Malaysia
ClinicalTrials.gov Identifier: NCT02523846    
Other Study ID Numbers: 20790
First Posted: August 14, 2015    Key Record Dates
Last Update Posted: August 17, 2015
Last Verified: August 2015
Keywords provided by Yeoh Lee Choo, Clinical Research Centre, Malaysia:
IV-Patient Controlled Analgesia (IV-PCA)
background morphine infusion
patient re-education
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents