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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

Tracking Information
First Submitted Date  ICMJE August 10, 2015
First Posted Date  ICMJE August 14, 2015
Last Update Posted Date August 17, 2015
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2015)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: August 13, 2015)
measure pain intensity at rest and when blowing incentive spirometer (dynamic pain) [ Time Frame: 48 hours after surgery ]
use combination of NRS and VAS scoring
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2015)
  • respiratory rate [ Time Frame: 48 hours after surgery ]
  • total accumulative morphine consumption from IV-PCA pump [ Time Frame: 48 hours after surgery ]
  • sedation level [ Time Frame: 48 hours after surgery ]
    sedation score (0 to 3)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patient Re-education vs. Background Morphine to IV-PCA in Patient With Unsatisfactory Analgesia Post Laparotomy
Official Title  ICMJE 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
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".

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Post-operative Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Background morphine infusion to IV-PCA Morphine
    Calculate based on patient's age, in mg/hour
    Interventions:
    • Drug: morphine
    • Behavioral: Patient re-education
  • Experimental: Patient re-education to IV-PCA Morphine
    Using patient information leaflet
    Intervention: Behavioral: Patient re-education
Publications * Macintyre PE, Jarvis DA. Age is the best predictor of postoperative morphine requirements. Pain. 1996 Feb;64(2):357-64.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 13, 2015)
160
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02523846
Other Study ID Numbers  ICMJE 20790
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yeoh Lee Choo, Clinical Research Centre, Malaysia
Study Sponsor  ICMJE Clinical Research Centre, Malaysia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: lee choo yeoh, master CRC Malaysia
PRS Account Clinical Research Centre, Malaysia
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP