Bariatric Surgery CandidatePhase 4NCT02778958
Comparisons of iv Ibuprofen and iv Paracetamol During Bariatric Surgery
A Phase 4 study testing paracetamol and ibuprofen in people with Bariatric Surgery Candidate and Obesity, Morbid, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate and to compare the effectiveness of iv ibuprofen and iv paracetamol during bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgery Candidate, Obesity, Morbid
- What is being tested?
- paracetamol and ibuprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2016to Mar 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing laparoscopic sleeve gastrectomy and gastric by-pass surgery
Who cannot join
- Hepatic disfunction,
- Renal failure (creatinine > 3 mg/dL,creatinin clearance < 60 mL/dk or urine out-put < 500 mL/day ) or a history of dialysis 28 days before surgery,
- A history of gastrointestinal bleeding or bleeding diathesis 6 weeks before surgery, therapeutic dose of anticoagulation therapy (except subcutaneous heparin prophylactic dose),
- Angiotensin converting enzymes inhibitor or antihypertensive combination with furosemide,
- A history of opioid addiction or opioid tolerance
- Allergy to study drugs,
- Noncooperative patients for pain assessments
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University Faculty of Medicine Department of Anesthesiology and Reanimation
Malatya, 44315
About this study
Official title: Comparisons of iv Ibuprofen and iv Paracetamol for Postoperative Pain Levels and Opioid Consumption During Bariatric Surgery
The aim of this study is to evaluate and to compare the effectiveness of iv ibuprofen and iv paracetamol during bariatric surgery.
Read the detailed description
Evaluation of effectiveness of iv ibuprofen and iv paracetamol on postoperative pain, opioid consumption, and side effects in morbidly obese patients undergoing bariatric laparoscopic surgery
- Conditions
- Bariatric Surgery Candidate, Obesity, Morbid
- Being tested
- paracetamol, ibuprofen
- Keywords
- bariatric surgery, morbid obesity, nonopioid analgesics
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracetamolDrug
Also called Acetaminophen
iv paracetamol flakon, 1 gram infusion at 30 min;
iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time)
ibuprofenDrug
Also called İntrafen
iv ibuprofen flakon, 800 mg;
iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time)
| Study group | Role | What they receive |
|---|---|---|
| ibuprofen and morphine | Experimental | iv ibuprofen 800 mg infusion at 30 min before skin incision closed and per 6 hours during postoperative period; iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time) Receives: Drug: ibuprofen |
| paracetamol and morphine | Active comparator | iv paracetamol 1 gram infusion at 30 min before skin incision closed and per 6 hours during postoperative period; iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time) Receives: Drug: paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid (morphine) consumption
iv morphine patient controlled analgesia for multimodal analgesia
Measured: First 24 hours during postoperative period
Secondary outcomes (1)
Postoperative pain level
Visual analog scale for evaluation of postoperative pain levels
Measured: First 24 hours during postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017
- Study completionMar 2017
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 Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulay ERDOGAN KAYHAN, Inonu University
- Investigators
- Gulay Erdogan Kayhan, MD, Principal investigator, Associated Professor Doctor Gulay ERDOGAN KAYHAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778958
- Sponsor's protocol ID
- Inonu Medicine Faculty
- Status last verified
- Mar 2018
- First submitted
- 17 May 2016
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kroll PB, Meadows L, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen (i.v.-ibuprofen) in the management of postoperative pain following abdominal hysterectomy. Pain Pract. 2011 Jan-Feb;11(1):23-32. doi: 10.1111/j.1533-2500.2010.00402.x.
PubMed 20642488
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of iv Ibuprofen and iv Paracetamol for Postoperative Pain Levels and Opioid Consumption During Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02778958
- Acronym / sponsor ID
- Inonu Medicine Faculty
- Conditions
- Bariatric Surgery Candidate, Obesity, Morbid
- Keywords
- bariatric surgery, morbid obesity, nonopioid analgesics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 20 May 2016 (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 this study is to evaluate and to compare the effectiveness of iv ibuprofen and iv paracetamol during bariatric surgery.
Detailed description
Evaluation of effectiveness of iv ibuprofen and iv paracetamol on postoperative pain, opioid consumption, and side effects in morbidly obese patients undergoing bariatric laparoscopic surgery
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 |
|---|---|---|
| ibuprofen and morphine | Experimental | Drug: ibuprofeniv ibuprofen 800 mg infusion at 30 min before skin incision closed and per 6 hours during postoperative period; iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time) |
| paracetamol and morphine | Active comparator | Drug: paracetamoliv paracetamol 1 gram infusion at 30 min before skin incision closed and per 6 hours during postoperative period; iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing laparoscopic sleeve gastrectomy and gastric by-pass surgery
Key exclusion criteria (7 listed)
- Hepatic disfunction,
- Renal failure (creatinine > 3 mg/dL,creatinin clearance < 60 mL/dk or urine out-put < 500 mL/day ) or a history of dialysis 28 days before surgery,
- A history of gastrointestinal bleeding or bleeding diathesis 6 weeks before surgery, therapeutic dose of anticoagulation therapy (except subcutaneous heparin prophylactic dose),
- Angiotensin converting enzymes inhibitor or antihypertensive combination with furosemide,
- A history of opioid addiction or opioid tolerance
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 |
|---|---|---|
| paracetamolAlso: Acetaminopheniv paracetamol flakon, 1 gram infusion at 30 min; iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time) | Drug | paracetamol and morphine |
| ibuprofenAlso: İntrafeniv ibuprofen flakon, 800 mg; iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time) | Drug | ibuprofen and morphine |
Primary outcome
Opioid (morphine) consumption
Time frame: First 24 hours during postoperative period
iv morphine patient controlled analgesia for multimodal analgesia
1 secondary outcome
Postoperative pain level
Time frame: First 24 hours during postoperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Results publication: PubMed 20642488Kroll PB, Meadows L, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen (i.v.-ibuprofen) in the management of postoperative pain following abdominal hysterectomy. Pain Pract. 2011 Jan-Feb;11(1):23-32. doi: 10.1111/j.1533-2500.2010.00402.x.
- Individual participant dataSharing planned: No
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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.
Gulay Erdogan Kayhan, MD principal investigator
Associated Professor Doctor Gulay ERDOGAN KAYHAN
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 paracetamol and ibuprofen in people with Bariatric Surgery Candidate and Obesity, Morbid, run by Inonu 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 7 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: finished, as of the sponsor's last update on 14 Mar 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid (morphine) consumption (time frame: First 24 hours during postoperative period). 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 NCT02778958, 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 14 Mar 2018.