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

NCT ID: NCT02254525

Last Updated: 2014-10-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 231 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-07-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intravenous ibuprofen

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

Saline solution

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

IV ibuprofen; Placebo

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pivotal S.L.

INDUSTRY

Sponsor Role: collaborator

Biomendi S.A.U.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Concepción Pérez, MD

Role: STUDY_CHAIR

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Francisco Abad, MD

Role: STUDY_CHAIR

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Dolores Ochoa, MD

Role: STUDY_CHAIR

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Antonio Planas, MD

Role: STUDY_CHAIR

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Locations

Complejo Hospitalario Universitario de A Coruña

A Coruña, La Coruña, Spain

Hospital Arnau de Vilanova de Lleida

Lleida, Lleida, Spain

Hospital La Princesa

Madrid, Madrid, Spain

Fundación Jiménez Díaz

Madrid, Madrid, Spain

Hospital 12 de Octubre

Madrid, Madrid, Spain

Hospital de Montepríncipe

Madrid, Madrid, Spain

Hospital de Móstoles

Móstoles, Madrid, Spain

Clínica Universitaria de Navarra

Pamplona, Pamplona, Spain

Hospital Xeral Cíes de Vigo

Vigo, Pontevedra, Spain

Hospital Virgen de la Salud

Toledo, Toledo, Spain

Hospital La Fe

Valencia, Valencia, Spain

Hospital Clínico de Valladolid

Valladolid, Valladolid, Spain

Hospital de Cruces

Barakaldo, Vizcaya, Spain

Countries

Spain

Other Identifiers

BIBEC02

Identifier Type: -

Identifier Source: org_study_id