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

• Register: ClinicalTrials.gov
• Last refreshed on: 24 August 2015
• Main ID: NCT02523846
• Date of registration: 10/08/2015
• Prospective Registration: No
• Primary sponsor: Clinical Research Centre, Malaysia
• Public title: Patient Re-education vs. Background Morphine to IV-PCA in Patient With Unsatisfactory Analgesia Post Laparotomy
• Scientific 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
• Date of first enrolment: August 2015
• Target sample size: 160
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02523846
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Malaysia

Contacts

• Name: yeoh lc

• Name: lee choo yeoh, master
• Affiliation: CRC Malaysia

• Name: Lee Choo Yeoh, Master

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Post-operative Pain

Intervention(s)

Behavioral: Patient re-education

Drug: morphine

Primary Outcome(s)

measure pain intensity at rest and when blowing incentive spirometer (dynamic pain) [Time Frame: 48 hours after surgery]

Secondary Outcome(s)

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]

Secondary ID(s)

20790

Source(s) of Monetary Support

Please refer to primary and secondary sponsors