Morbid ObesityPhase 4NCT02017314
VAS Correlation With BMI
A Phase 4 study testing Morphine in people with Morbid Obesity, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to observe if any correlation between Body mass index and VAS values exists in patients who has gone under abdominal surgery. Group I : Patients with BMI<30 Group II: Patients with BMI between 30 and 34.9 Group III: Patients with BMI between 35 and 39.9 Group IV: Patients with BMI between 40… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2013to Mar 2014
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients undergoing abdominal surgery and who will be given PCA treatment for postoperative pain.
Who cannot join
- patients younger than 18 years old, patients with uncompensated diabetes or related polyneuropathy, patients receiving antidepressants or have a diagnosis of depression
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Cerrahpasa Medical School
Istanbul, Marmara
emre erbabacan, specialist, 00905322067777, emreerbabacan@hotmail.com
About this study
Official title: Correlation of Postoperative VAS Values and Body Mass Index in Patients Undergoing Abdominal Surgery: A Clinical Trial
The aim of the study is to observe if any correlation between Body mass index and VAS values exists in patients who has gone under abdominal surgery.
Group I : Patients with BMI<30 Group II: Patients with BMI between 30 and 34.9 Group III: Patients with BMI between 35 and 39.9 Group IV: Patients with BMI between 40 and 49.9 Group V : Patients with BMI >50
After the end of surgery patients will be extubated and in the recovery room morphine PCA (patient-controlled analgesia) treatment will be started according to their adjusted body weight. When VAS values over 4,10 mg/kg Paracetamol IV will be used as an escape treatment. VAS values and Delivery and Demand of the PCA and additional need for analgesics will be recorded in the first 48 hours.
- Conditions
- Morbid Obesity
- Being tested
- Morphine
- Keywords
- morbid obesity, postoperative pain
- Medical subject headings
- Obesity, Morbid, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
| Study group | Role | What they receive |
|---|---|---|
| Group 5 | Active comparator | Patients with BMI > 50 Receives: Drug: Morphine |
| Group IV | Active comparator | Patients with BMI between 40 and 49.9 Receives: Drug: Morphine |
| Group III | Active comparator | Patients with BMI between 35 and 39.9 Receives: Drug: Morphine |
| Group II | Active comparator | patients with BMI between 30 and 34.9 Receives: Drug: Morphine |
| Group I | Active comparator | Patients with BMI <30 Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores on the Visual Analog Scale
Correlation between the VAS Scores and BMI will evaluated
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (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 Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guniz M.Koksal, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017314
- Sponsor's protocol ID
- 830458909
- Status last verified
- Dec 2013
- First submitted
- 8 Dec 2013
- Last updated
- 20 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Choi YK, Brolin RE, Wagner BK, Chou S, Etesham S, Pollak P. Efficacy and safety of patient-controlled analgesia for morbidly obese patients following gastric bypass surgery. Obes Surg. 2000 Apr;10(2):154-9. doi: 10.1381/096089200321668703.
PubMed 10782177
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Postoperative VAS Values and Body Mass Index in Patients Undergoing Abdominal Surgery: A Clinical Trial
- ClinicalTrials.gov ID
- NCT02017314
- Acronym / sponsor ID
- 830458909
- Conditions
- Morbid Obesity
- Keywords
- morbid obesity, postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 20 Dec 2013 (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 aim of the study is to observe if any correlation between Body mass index and VAS values exists in patients who has gone under abdominal surgery.
Group I : Patients with BMI<30 Group II: Patients with BMI between 30 and 34.9 Group III: Patients with BMI between 35 and 39.9 Group IV: Patients with BMI between 40 and 49.9 Group V : Patients with BMI >50
After the end of surgery patients will be extubated and in the recovery room morphine PCA (patient-controlled analgesia) treatment will be started according to their adjusted body weight. When VAS values over 4,10 mg/kg Paracetamol IV will be used as an escape treatment. VAS values and Delivery and Demand of the PCA and additional need for analgesics will be recorded in the first 48 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 5 | Active comparator | Drug: MorphinePatients with BMI > 50 |
| Group IV | Active comparator | Drug: MorphinePatients with BMI between 40 and 49.9 |
| Group III | Active comparator | Drug: MorphinePatients with BMI between 35 and 39.9 |
| Group II | Active comparator | Drug: Morphinepatients with BMI between 30 and 34.9 |
| Group I | Active comparator | Drug: MorphinePatients with BMI <30 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients undergoing abdominal surgery and who will be given PCA treatment for postoperative pain.
Key exclusion criteria (1 listed)
- patients younger than 18 years old, patients with uncompensated diabetes or related polyneuropathy, patients receiving antidepressants or have a diagnosis of depression
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 |
|---|---|---|
| Morphine | Drug | Group 5, Group I, Group II, Group III, Group IV |
Primary outcome
Pain Scores on the Visual Analog Scale
Time frame: 48 hours
Correlation between the VAS Scores and BMI will evaluated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2013.
- Background: PubMed 10782177Choi YK, Brolin RE, Wagner BK, Chou S, Etesham S, Pollak P. Efficacy and safety of patient-controlled analgesia for morbidly obese patients following gastric bypass surgery. Obes Surg. 2000 Apr;10(2):154-9. doi: 10.1381/096089200321668703.
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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.
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 in people with Morbid Obesity, run by Istanbul University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 20 Dec 2013. 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 Turkey (Türkiye). 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 guniz koksal, Ass.Prof (2124143000 ext. 21876, gunizkoksal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores on the Visual Analog Scale (time frame: 48 hours). 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 NCT02017314, 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 20 Dec 2013.