Post-operative Pain
Conditions
Keywords
IV-Patient Controlled Analgesia (IV-PCA), background morphine infusion, patient re-education
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.
Interventions
DRUGmorphine
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)
BEHAVIORALPatient 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
Sponsors
Clinical Research Centre, Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| measure pain intensity at rest and when blowing incentive spirometer (dynamic pain) | 48 hours after surgery | use combination of Numerical Rating Scale(NRS) and Visual Analogue Scale(VAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| respiratory rate | 48 hours after surgery | — |
| total accumulative morphine consumption from IV-PCA pump | 48 hours after surgery | — |
| sedation level | 48 hours after surgery | sedation score (0 to 3) |
Countries
Malaysia
Contacts
Primary ContactLee Choo Yeoh, Master
Outcome results
None listed