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

Post-operative Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02523846
• Other study ID #: 20790
• Status: Recruiting
• Phase: Phase 4
• First received: August 10, 2015
• Last updated: August 14, 2015
• Start date: August 2015

Study information

• Verified date: August 2015
• Source: Clinical Research Centre, Malaysia
• Contact: Lee Choo Yeoh, Master
• Phone: 047722625
• Email: yeohlc55[@]yahoo.com
• Is FDA regulated: No
• Health authority: Malaysia: Malaysia National Medical Research Registry
• Study type: Interventional

Clinical Trial 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.

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".

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

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

Locations

Country	Name	City	State
Malaysia	Sultanah Bahiyah Hospital	Alor Seatr	Kedah

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Research Centre, Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (1)

Macintyre PE, Jarvis DA. Age is the best predictor of postoperative morphine requirements. Pain. 1996 Feb;64(2):357-64. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	respiratory rate		48 hours after surgery	Yes
Secondary	total accumulative morphine consumption from IV-PCA pump		48 hours after surgery	Yes
Secondary	sedation level	sedation score (0 to 3)	48 hours after surgery	Yes