Post-surgical orthopedic pain after primary, cemented total hip replacement associated with moderate to severe pain MedDRA version: 9.1 Level: LLT Classification code 10054710 Term: Postoperative hip pain MedDRA version: 9.1 Level: LLT Classification code 10054711 Term: Postoperative pain
Conditions
Interventions
Product Name: Paracetamol 1% Bioren
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Paracetamol
Concentration unit: % (W/V) percent weight/volume
Concentration type: equal
Concentratio
Sponsors
Baxter R&D Europe S.C.R.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject has provided written informed consent prior to performing any study related procedures. 2. Male / female subjects, 18-75 years of age inclusive. 3. Body mass index (BMI) 18-40 inclusive. 4. Subject is in good health as determined by the Principal Investigator on the basis of medical history and physical examination. 5. American Society of Anesthesiologists (ASA) Grade I, Grade II or Grade III, scheduled for elective total hip replacement, using a standard approach and a cemented implant. 6. A negative urine pregnancy test for all female subjects of childbearing potential (a female is considered to be of childbearing potential if they have not been postmenopausal for at least 24 consecutive months or if they have a uterus and at least one ovary) immediately before surgery (performed on the ward in the morning of the procedure). 7. Subjects will be randomized and assigned medication if they rate their pain as moderate or severe assessed on a four-point verbal rating scale (VRS) within 4 hours of stopping the PCA in the morning of the first post-operative day. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Another acute or chronic painful physical condition (e.g.: concomitant malignant disease). 2. The subject requires a total hip replacement due to a fracture of the hip. 3. The use of non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin, within the 12 hours preceding administration of study medication. 4. The use of any other analgesic drugs (except morphine administration by PCA) within the 12 hours preceding administration of study medication. 5. Specifically excluded are tricyclic antidepressants (TCAs), antihistamines, tranquilizers, hypnotics, sedatives and Cyclooxygenase-2 (COX-2) specific inhibitors. 6. The use of any corticosteroid drugs within the 7 days preceding administration of study medication. 7. The subject has a history of uncontrolled chronic disease, which in the opinion of the Principal Investigator would contraindicate study participation. 8. The subject has a disease/condition that is known to be a contraindication for treatment with morphine. 9. Inability to use or understand the visual analog scale (VAS) pain score and/or the Verbal Rating Score (VRS). 10. Known hepatic disorders: Liver dysfunction defined as an elevation of alanine aminotransferase (ALT), aspartate aminotransferase (AST) or gamma glutamyl transpeptidase (GGT) 2 times above the upper limit of normal (ULN). 11. Known renal disorders: Advanced renal dysfunction defined as an elevation of serum creatinine 2 times the ULN. 12. Known genetic defect of glucose-6-phosphate-dehydrogenase. 13. Psychiatric or medical conditions which would preclude safe surgery. 14. Concomitant use of microsomial enzyme inducers (see Appendix B). 15. Pregnant or breast feeding women. 16. Women of childbearing potential not using adequate contraception (one method of contraception is considered to be adequate). 17. Known sensitivity to the NSAID class of drugs, paracetamol or other analgesics. 18. A contraindication to paracetamol. 19. History of non-response to paracetamol. 20. A bleeding disorder. 21. Any history of gastrointestinal bleeding. 22. Any laboratory abnormality, which in the opinion of the Principal Investigator would preclude study participation. 23. History of analgesic, narcotic or alcohol dependence (substance abuse). 24. History of participating in another clinical investigation, or taking another investigational drug within 1 month prior to surgery. 25. Dehydration or chronic malnutrition. 26. Confined persons and prisoners.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the therapeutic efficacy and safety of a single dose of 100 mL 1% paracetamol solution Bioren compared to placebo in terms of total morphine consumption over 6 hours after the first study drug administration.;Secondary Objective: To compare the therapeutic efficacy and safety of single and repeated dose(s) of 100 mL 1% paracetamol solution Bioren to 100 mL Perfalgan®1%. To compare the therapeutic efficacy and safety of repeated doses of 100 mL 1% paracetamol solution Bioren to placebo. ;Primary end point(s): Total consumption of morphine over the first 6 hours following the first administration of study medication (comparison test vs. placebo). | — |
Countries
Hungary
Outcome results
None listed