Postoperative PainPhase 3NCT02254525
A Multicenter Trial of the Efficacy and Safety of a New Formulation of Ibuprofen 800 mg Every 6 Hours in the Management of Postoperative Pain
A Phase 3 study testing Intravenous ibuprofen and Saline solution in people with Postoperative Pain, run by Biomendi S.A.U. at 13 sites in Spain.
Trial summary
The purpose of this study is to study the efficacy of intravenous administration of ibuprofen compared to placebo in patients with postoperative pain and evaluate its tolerability and safety profile. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Intravenous ibuprofen and Saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 231 participants
- Where
- 13 sitesSpain
- Study dates
- May 2012to Jul 2014
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women between 18 and 80 years old.
- Being scheduled for elective single surgical site orthopaedic surgery (hip or knee joint replacement, corsed ligaments, column or shoulder surgery), or abdominal surgery (inguinal hernia, cholecystectomy, eventration or hiatus hernia)
- Being scheduled for general anaesthesia or regional anesthesia without regional analgesia after surgery.
- Having anticipated need for postoperative narcotic analgesia administered by patient controlled analgesia (PCA).
- Expected to stay at the hospital for at least 24 h.
- Providing written informed consent for participating in this study.
Who cannot join
- Use of NSAID within 12 hours prior to the first planned dose.
- Taking oral anticoagulants, lithium, combination of ACE inhibitors, furosemide or aspirin.
- Anaemia (haemoglobin <10 g/dl) and/or history or evidence of asthma or heart failure.
- History of allergy or hypersensitivity to any component of IV ibuprofen, aspirin or aspirin related products, NSAID or COX-2 inhibitors.
- Pregnant or nursing.
- Weight less than 40 kg.
Show all 15Show fewer
- History of severe head trauma that required hospitalization, intracranial surgery or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurism or CNS mass lesion.
- History of congenital bleeding diathesis or any active clinically significant bleeding or underlying platelet dysfunction.
- Gastrointestinal bleeding that required medical intervention.
- Platelet count less than 80.000 determined within the 28 days prior to surgery.
- Pre-existing dependence on narcotics or receiving chronic treatment with opioids.
- Severe renal failure (calculated creatinine clearance < 60 ml/min).
- Liver failure, ALAT or ASAT >3 times upper limit of normality, or bilirubin >2 g/dl.
- Diagnosed of Bowel Inflammatory Disease.
- Not able to understand the requirements of the study, or to abide by the study restrictions or to return for the required assessments.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Spain13 sites
Complejo Hospitalario Universitario de A Coruña
A Coruña, La Coruña, 15001
Hospital de Cruces
Barakaldo, Vizcaya, 48903
Hospital Arnau de Vilanova de Lleida
Lleida, Lleida, 25198
Hospital La Princesa
Madrid, Madrid, 28006
Fundación Jiménez Díaz
Madrid, Madrid, 28040
Hospital 12 de Octubre
Madrid, Madrid, 28041
Hospital de Montepríncipe
Madrid, Madrid, 28660
Hospital de Móstoles
Móstoles, Madrid, 28935
Clínica Universitaria de Navarra
Pamplona, Pamplona, 31008
Hospital Virgen de la Salud
Toledo, Toledo, 45005
Hospital La Fe
Valencia, Valencia, 46026
Hospital Clínico de Valladolid
Valladolid, Valladolid, 47005
Hospital Xeral Cíes de Vigo
Vigo, Pontevedra, 15781
About this study
Official title: A Multicenter, Randomized, Double-blind, and Parallel Groups, Placebo-controlled Trial of the Efficacy and Safety of a New Formulation of Ibuprofen 800 mg Every 6 Hours in the Management of Postoperative Pain.
The purpose of this study is to study the efficacy of intravenous administration of ibuprofen compared to placebo in patients with postoperative pain and evaluate its tolerability and safety profile.
Read the detailed description
This is a phase III, national, multicenter, randomized, double-blind, parallel groups, and placebo-controlled.
Patients will be randomized to receive either ibuprofen or placebo. Stratified randomization will be used to assign eligible patients to a stratum according to type of surgery and centre. Randomization sequence will be generated in the coordinating centre.
Blinding of the patient and study personnel evaluating response will be warranted by adequate drug labelling.
All patients will receive morphine administered by patient controlled analgesia (PCA) following a similar schedule in all centres: 1 mg bolus dose with a close time of 5 min and a maximum of 10 mg in an hour and a maximum of 30 mg in 4 hours.
- Conditions
- Postoperative Pain
- Being tested
- Intravenous ibuprofen, Saline solution
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous ibuprofenDrug
Also called IV ibuprofen
Treatment group: 800 mg IV ibuprofen, starting at the moment of skin closure and every 6 hours up to 72 hours after the first dose.
All patients will receive morphine administered by patient controlled analgesia (PCA). Investigation treatment will be administered every 6 hours until 24 h in abdominal surgery, 48 h in hip surgery and 72 h in knee surgery.
Saline solutionDrug
Also called Placebo
Placebo group: 200 ml of saline solution, starting at the moment of skin closure and every 6 hours up to 72 hours after the first dose.
All patients will receive morphine administered by patient controlled analgesia (PCA). Investigation treatment will be administered every 6 hours until 24 h in abdominal surgery, 48 h in hip surgery and 72 h in knee surgery.
| Study group | Role | What they receive |
|---|---|---|
| 800 mg intravenous ibuprofen | Experimental | Treatment group: 800 mg IV ibuprofen, starting at the moment of skin closure and every 6 hours, infused over 15 minutes. Receives: Drug: Intravenous ibuprofen |
| 200 ml of saline solution | Placebo comparator | Placebo group: 200 ml of saline solution, starting at the moment of skin closure and every 6 hours, infused over 15 min. Receives: Drug: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of intravenous ibuprofen for the management of postoperative pain in comparison to placebo
The primary efficacy endpoint will be the reduction in total morphine use in the first 24 hours post- surgery as compared to placebo.
Measured: First 24 hours post- surgery
Secondary outcomes (9)
Secondary efficacy endpoints
- Consumption of morphine in the first 48 h (and 72) hours post- surgery.
Measured: From 0 hours to 72 hours post- surgery
Secondary efficacy endpoints
- Pain intensity at rest and with movement measured with the eleven points visual analogue scale (VAS), at 1 and 3 hours and every 6 hours thereafter up to hour 24 h, and then every 8 h up to 6 hour after the last ibuprofen dose.
Measured: From 0 hours to 72 hours post- surgery
Secondary efficacy endpoints
- Ramsay-Hunt sedation scale.
Measured: From 0 hours to 72 hours post- surgery
Secondary efficacy endpoints
- Time to first subsequent narcotic analgesia (or time to treatment failure).
Measured: From 0 hours to 72 hours post- surgery
Secondary efficacy endpoints
- Number of doses of morphine and number of attempts of dosing at PCA
Measured: From 0 hours to 72 hours post- surgery
Secondary tolerability and safety endpoints
- Report of adverse events (AEs) during the study
Measured: From 0 hours to 72 hours post- surgery
Secondary tolerability and safety endpoints
- Local reactions due to IV infusion (pain, erythema, phlebitis)
Measured: From 0 hours to 72 hours post- surgery
Secondary tolerability and safety endpoints
- Vital signs (heart rate, blood pressure, temperature) at 1, 3, 6 hour after the initial dose and every 8 hours thereafter.
Measured: From 0 hours to 72 hours post- surgery
Secondary tolerability and safety endpoints
- Routine laboratory tests (chemistry, haematology and coagulation) at baseline and within 24 hours after the last dose.
Measured: From 0 hours to 72 hours post- surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startMay 2012
- Primary completionJun 2014
- Study completionJul 2014
Why it stopped: Sample not reached in traumathology arm
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomendi S.A.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pivotal S.L.
- Responsible party
- Sponsor
- Investigators
- Concepción Pérez, MD, Study chair, Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaFrancisco Abad, MD, Study chair, Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaDolores Ochoa, MD, Study chair, Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaAntonio Planas, MD, Study chair, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254525
- Sponsor's protocol ID
- BIBEC02
- Status last verified
- Sep 2014
- First submitted
- 25 Sep 2014
- Last updated
- 2 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, and Parallel Groups, Placebo-controlled Trial of the Efficacy and Safety of a New Formulation of Ibuprofen 800 mg Every 6 Hours in the Management of Postoperative Pain.
- ClinicalTrials.gov ID
- NCT02254525
- Acronym / sponsor ID
- BIBEC02
- Conditions
- Postoperative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sample not reached in traumathology arm
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Biomendi S.A.U.Industry (pharma, biotech, devices)
- Collaborators
- Pivotal S.L.
- Study start
- May 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 2 Oct 2014 (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 study the efficacy of intravenous administration of ibuprofen compared to placebo in patients with postoperative pain and evaluate its tolerability and safety profile.
Detailed description
This is a phase III, national, multicenter, randomized, double-blind, parallel groups, and placebo-controlled.
Patients will be randomized to receive either ibuprofen or placebo. Stratified randomization will be used to assign eligible patients to a stratum according to type of surgery and centre. Randomization sequence will be generated in the coordinating centre.
Blinding of the patient and study personnel evaluating response will be warranted by adequate drug labelling.
All patients will receive morphine administered by patient controlled analgesia (PCA) following a similar schedule in all centres: 1 mg bolus dose with a close time of 5 min and a maximum of 10 mg in an hour and a maximum of 30 mg in 4 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 800 mg intravenous ibuprofen | Experimental | Drug: Intravenous ibuprofenTreatment group: 800 mg IV ibuprofen, starting at the moment of skin closure and every 6 hours, infused over 15 minutes. |
| 200 ml of saline solution | Placebo comparator | Drug: Saline solutionPlacebo group: 200 ml of saline solution, starting at the moment of skin closure and every 6 hours, infused over 15 min. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women between 18 and 80 years old.
- Being scheduled for elective single surgical site orthopaedic surgery (hip or knee joint replacement, corsed ligaments, column or shoulder surgery), or abdominal surgery (inguinal hernia, cholecystectomy, eventration or hiatus hernia)
- Being scheduled for general anaesthesia or regional anesthesia without regional analgesia after surgery.
- Having anticipated need for postoperative narcotic analgesia administered by patient controlled analgesia (PCA).
- Expected to stay at the hospital for at least 24 h.
Key exclusion criteria (15 listed)
- Use of NSAID within 12 hours prior to the first planned dose.
- Taking oral anticoagulants, lithium, combination of ACE inhibitors, furosemide or aspirin.
- Anaemia (haemoglobin <10 g/dl) and/or history or evidence of asthma or heart failure.
- History of allergy or hypersensitivity to any component of IV ibuprofen, aspirin or aspirin related products, NSAID or COX-2 inhibitors.
- Pregnant or nursing.
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 |
|---|---|---|
| Intravenous ibuprofenAlso: IV ibuprofenTreatment group: 800 mg IV ibuprofen, starting at the moment of skin closure and every 6 hours up to 72 hours after the first dose. All patients will receive morphine administered by patient controlled analgesia (PCA). Investigation treatment will be administered every 6 hours until 24 h in abdominal surgery, 48 h in hip surgery and 72 h in knee surgery. | Drug | 800 mg intravenous ibuprofen |
| Saline solutionAlso: PlaceboPlacebo group: 200 ml of saline solution, starting at the moment of skin closure and every 6 hours up to 72 hours after the first dose. All patients will receive morphine administered by patient controlled analgesia (PCA). Investigation treatment will be administered every 6 hours until 24 h in abdominal surgery, 48 h in hip surgery and 72 h in knee surgery. | Drug | 200 ml of saline solution |
Primary outcome
Evaluate the efficacy of intravenous ibuprofen for the management of postoperative pain in comparison to placebo
Time frame: First 24 hours post- surgery
The primary efficacy endpoint will be the reduction in total morphine use in the first 24 hours post- surgery as compared to placebo.
9 secondary outcomes
Secondary efficacy endpoints
Time frame: From 0 hours to 72 hours post- surgery
Secondary efficacy endpoints
Time frame: From 0 hours to 72 hours post- surgery
Secondary efficacy endpoints
Time frame: From 0 hours to 72 hours post- surgery
Secondary efficacy endpoints
Time frame: From 0 hours to 72 hours post- surgery
Secondary efficacy endpoints
Time frame: From 0 hours to 72 hours post- surgery
Secondary tolerability and safety endpoints
Time frame: From 0 hours to 72 hours post- surgery
Secondary tolerability and safety endpoints
Time frame: From 0 hours to 72 hours post- surgery
Secondary tolerability and safety endpoints
Time frame: From 0 hours to 72 hours post- surgery
Secondary tolerability and safety endpoints
Time frame: From 0 hours to 72 hours post- surgery
Results and safety
The study was stopped early (reason given: Sample not reached in traumathology arm). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Concepción Pérez, MD study chair
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Francisco Abad, MD study chair
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Dolores Ochoa, MD study chair
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous ibuprofen and Saline solution in people with Postoperative Pain, run by Biomendi S.A.U. at 13 sites in Spain.
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 6 inclusion and 15 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: stopped early, as of the sponsor's last update on 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Sample not reached in traumathology arm). Results are not available in the source record.
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?
Evaluate the efficacy of intravenous ibuprofen for the management of postoperative pain in comparison to placebo (time frame: First 24 hours post- surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2014.