Post-operative PainPhase 4NCT02523846
Patient Re-education vs. Background Morphine to IV-PCA in Patient With Unsatisfactory Analgesia Post Laparotomy
A Phase 4 study testing morphine and Patient re-education in people with Post-operative Pain, run by Clinical Research Centre, Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- morphine and Patient re-education
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteMalaysia
- Study dates
- Aug 2015to Jul 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Sultanah Bahiyah Hospital
Alor Seatr, Kedah, 05050
yeoh lc, 047722625, yeohlc55@yahoo.com
About this study
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
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.
Read the 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".
- Conditions
- Post-operative Pain
- Being tested
- morphine, Patient re-education
- Keywords
- IV-Patient Controlled Analgesia (IV-PCA), background morphine infusion, patient re-education
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
morphineDrug
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)
Patient re-educationBehavioural
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 group | Role | What they receive |
|---|---|---|
| Background morphine infusion to IV-PCA Morphine | Active comparator | Calculate based on patient's age, in mg/hour Receives: Drug: morphine; Behavioral: Patient re-education |
| Patient re-education to IV-PCA Morphine | Experimental | Using patient information leaflet Receives: Behavioral: Patient re-education |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure pain intensity at rest and when blowing incentive spirometer (dynamic pain)
use combination of Numerical Rating Scale(NRS) and Visual Analogue Scale(VAS)
Measured: 48 hours after surgery
Secondary outcomes (3)
respiratory rate
Measured: 48 hours after surgery
total accumulative morphine consumption from IV-PCA pump
Measured: 48 hours after surgery
sedation level
sedation score (0 to 3)
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Research Centre, Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeoh Lee Choo, Clinical Research Centre, Malaysia
- Investigators
- lee choo yeoh, master, Principal investigator, CRC Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523846
- Sponsor's protocol ID
- 20790
- Status last verified
- Aug 2015
- First submitted
- 10 Aug 2015
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Macintyre PE, Jarvis DA. Age is the best predictor of postoperative morphine requirements. Pain. 1996 Feb;64(2):357-364. doi: 10.1016/0304-3959(95)00128-X.
PubMed 8740614
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02523846
- Acronym / sponsor ID
- 20790
- Conditions
- Post-operative Pain
- Keywords
- IV-Patient Controlled Analgesia (IV-PCA), background morphine infusion, patient re-education
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Clinical Research Centre, MalaysiaUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (estimated)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Background morphine infusion to IV-PCA Morphine | Active comparator | Drug: morphine, Behavioral: Patient re-educationCalculate based on patient's age, in mg/hour |
| Patient re-education to IV-PCA Morphine | Experimental | Behavioral: Patient re-educationUsing patient information leaflet |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| morphineInvestigators 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) | Drug | Background morphine infusion to IV-PCA Morphine |
| Patient re-educationA 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 | Behavioural | Background morphine infusion to IV-PCA Morphine, Patient re-education to IV-PCA Morphine |
Primary outcome
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)
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
- Results publication: PubMed 8740614Macintyre PE, Jarvis DA. Age is the best predictor of postoperative morphine requirements. Pain. 1996 Feb;64(2):357-364. doi: 10.1016/0304-3959(95)00128-X.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
lee choo yeoh, master principal investigator
CRC Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing morphine and Patient re-education in people with Post-operative Pain, run by Clinical Research Centre, Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lee Choo Yeoh, Master (047722625, yeohlc55@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure pain intensity at rest and when blowing incentive spirometer (dynamic pain) (time frame: 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02523846, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2015; AzTrials last refreshed its copy on 6 Nov 2026.