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

Phase 3

Terminated

• Conditions: Postoperative Pain
• Interventions: Drug: Intravenous ibuprofen; Drug: Saline solution

• Registration Number: NCT02254525
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-05
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Status Verified: 2014-09
• Study First Submitted: 2014-09-25
• Study First Submitted QC: 2014-10-01
• Last Update Submitted: 2014-10-01
• Study First Posted: 2014-10-02
• Last Update Posted: 2014-10-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 231

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
800 mg intravenous ibuprofen	Intravenous ibuprofen	Treatment 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	Saline solution	Placebo group: 200 ml of saline solution, starting at the moment of skin closure and every 6 hours, infused over 15 min.

Primary Outcome Measures

Name	Time	Method
Evaluate the efficacy of intravenous ibuprofen for the management of postoperative pain in comparison to placebo	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

Name	Time	Method
Secondary tolerability and safety endpoints	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.
Secondary efficacy endpoints	From 0 hours to 72 hours post- surgery	- Number of doses of morphine and number of attempts of dosing at PCA

Trial Locations

Locations (13)

Hospital de Cruces; 🇪🇸 Barakaldo, Vizcaya, Spain

Hospital de Móstoles; 🇪🇸 Móstoles, Madrid, Spain

Complejo Hospitalario Universitario de A Coruña; 🇪🇸 La Coruña, Spain

Hospital Clínico de Valladolid; 🇪🇸 Valladolid, Spain

Hospital Xeral Cíes de Vigo; 🇪🇸 Vigo, Pontevedra, Spain

Hospital La Fe; 🇪🇸 Valencia, Spain

Hospital Virgen de la Salud; 🇪🇸 Toledo, Spain

Hospital Arnau de Vilanova de Lleida; 🇪🇸 Lleida, Spain

Hospital La Princesa; 🇪🇸 Madrid, Spain

Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital de Montepríncipe; 🇪🇸 Madrid, Spain

Clínica Universitaria de Navarra; 🇪🇸 Pamplona, Spain