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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

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ClinicalTrials.gov Identifier: NCT02254525
Recruitment Status : Terminated (Sample not reached in traumathology arm)
First Posted : October 2, 2014
Last Update Posted : October 2, 2014
Sponsor:
Collaborator:
Pivotal S.L.
Information provided by (Responsible Party):
Biomendi S.A.U.

Brief 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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Intravenous ibuprofen Drug: Saline solution Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : May 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 800 mg intravenous ibuprofen
Treatment group: 800 mg IV ibuprofen, starting at the moment of skin closure and every 6 hours, infused over 15 minutes.
Drug: Intravenous 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.

Other Name: IV ibuprofen

Placebo Comparator: 200 ml of saline solution
Placebo group: 200 ml of saline solution, starting at the moment of skin closure and every 6 hours, infused over 15 min.
Drug: Saline solution

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.

Other Name: Placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Secondary efficacy endpoints [ Time Frame: From 0 hours to 72 hours post- surgery ]
    - Consumption of morphine in the first 48 h (and 72) hours post- surgery.

  2. Secondary efficacy endpoints [ Time Frame: From 0 hours to 72 hours post- surgery ]
    - 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.

  3. Secondary efficacy endpoints [ Time Frame: From 0 hours to 72 hours post- surgery ]
    - Ramsay-Hunt sedation scale.

  4. Secondary efficacy endpoints [ Time Frame: From 0 hours to 72 hours post- surgery ]
    - Time to first subsequent narcotic analgesia (or time to treatment failure).

  5. Secondary efficacy endpoints [ Time Frame: From 0 hours to 72 hours post- surgery ]
    - Number of doses of morphine and number of attempts of dosing at PCA

  6. Secondary tolerability and safety endpoints [ Time Frame: From 0 hours to 72 hours post- surgery ]
    - Report of adverse events (AEs) during the study

  7. Secondary tolerability and safety endpoints [ Time Frame: From 0 hours to 72 hours post- surgery ]
    - Local reactions due to IV infusion (pain, erythema, phlebitis)

  8. Secondary tolerability and safety endpoints [ Time Frame: From 0 hours to 72 hours post- surgery ]
    - Vital signs (heart rate, blood pressure, temperature) at 1, 3, 6 hour after the initial dose and every 8 hours thereafter.

  9. Secondary tolerability and safety endpoints [ Time Frame: From 0 hours to 72 hours post- surgery ]
    - Routine laboratory tests (chemistry, haematology and coagulation) at baseline and within 24 hours after the last dose.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men or women between 18 and 80 years old.
  2. 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)
  3. Being scheduled for general anaesthesia or regional anesthesia without regional analgesia after surgery.
  4. Having anticipated need for postoperative narcotic analgesia administered by patient controlled analgesia (PCA).
  5. Expected to stay at the hospital for at least 24 h.
  6. Providing written informed consent for participating in this study.

Exclusion Criteria:

  1. Use of NSAID within 12 hours prior to the first planned dose.
  2. Taking oral anticoagulants, lithium, combination of ACE inhibitors, furosemide or aspirin.
  3. Anaemia (haemoglobin <10 g/dl) and/or history or evidence of asthma or heart failure.
  4. History of allergy or hypersensitivity to any component of IV ibuprofen, aspirin or aspirin related products, NSAID or COX-2 inhibitors.
  5. Pregnant or nursing.
  6. Weight less than 40 kg.
  7. 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.
  8. History of congenital bleeding diathesis or any active clinically significant bleeding or underlying platelet dysfunction.
  9. Gastrointestinal bleeding that required medical intervention.
  10. Platelet count less than 80.000 determined within the 28 days prior to surgery.
  11. Pre-existing dependence on narcotics or receiving chronic treatment with opioids.
  12. Severe renal failure (calculated creatinine clearance < 60 ml/min).
  13. Liver failure, ALAT or ASAT >3 times upper limit of normality, or bilirubin >2 g/dl.
  14. Diagnosed of Bowel Inflammatory Disease.
  15. Not able to understand the requirements of the study, or to abide by the study restrictions or to return for the required assessments.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254525


Locations
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Spain
Hospital de Móstoles
Móstoles, Madrid, Spain, 28935
Hospital Xeral Cíes de Vigo
Vigo, Pontevedra, Spain, 15781
Hospital de Cruces
Barakaldo, Vizcaya, Spain, 48903
Complejo Hospitalario Universitario de A Coruña
La Coruña, Spain, 15001
Hospital Arnau de Vilanova de Lleida
Lleida, Spain, 25198
Hospital La Princesa
Madrid, Spain, 28006
Fundación Jiménez Díaz
Madrid, Spain, 28040
Hospital 12 de Octubre
Madrid, Spain, 28041
Hospital de Montepríncipe
Madrid, Spain, 28660
Clínica Universitaria de Navarra
Pamplona, Spain, 31008
Hospital Virgen de la Salud
Toledo, Spain, 45005
Hospital La Fe
Valencia, Spain, 46026
Hospital Clínico de Valladolid
Valladolid, Spain, 47005
Sponsors and Collaborators
Biomendi S.A.U.
Pivotal S.L.
Investigators
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Study Chair: Concepción Pérez, MD Hospital La Princesa
Study Chair: Francisco Abad, MD Hospital La Princesa
Study Chair: Dolores Ochoa, MD Hospital La Princesa
Study Chair: Antonio Planas, MD Hospital La Princesa

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Responsible Party: Biomendi S.A.U.
ClinicalTrials.gov Identifier: NCT02254525     History of Changes
Other Study ID Numbers: BIBEC02
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: October 2, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Ibuprofen
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Pharmaceutical Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action