Pain after total hip replacement surgery MedDRA version: 19.1 Level: LLT Classification code 10044088 Term: Total hip replacement System Organ Class: 100000004865 MedDRA version: 19.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863
Conditions
Interventions
Trade Name: Pinex
Pharmaceutical Form: Capsule
INN or Proposed INN: Paracetamol
Other descriptive name: PARACETAMOL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
Næstved Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Scheduled for unilateral, primary THA • Age > 18 • ASA 1-3. • BMI > 18 and =65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
Exclusion criteria: • Patients who cannot cooperate with the trial. • Concomitant participation in another trial • Patients who cannot understand or speak Danish. • Daily use of strong opioids (tramadol and codein are accepted) • Patients with allergy to the medicines used in the trial. • Contraindications against NSAID or paracetamol, for example previous ulcer, heart failure, liver failure, or renal failure (eGRF < 60 ml/kg/1,73m2), known thrombocytopenia (<100 mia/L) • Patients suffering from alcohol and/or drug abuse – based on the investigator's judgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this trial is to investigate the analgesic effects and safety of paracetamol and ibuprofen and their combination in different dosages after THA;Secondary Objective: Not applicable;Primary end point(s): • Total need for morphine the first 24 hours postoperatively administered as BOTH patient controlled analgesia (PCA) and supplemental morphine administered at the post-anaesthesia unit the first hour postoperatively • Serious adverse events, including death, within 90 days after surgery defined as SAE (according to ICH-GCP-guidelines) except “prolongation of hospitalisation” ;Timepoint(s) of evaluation of this end point: Morphine consumption at 24 hours post surgery Number of patients with one or more SAE's at 90 days post surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end-points: • Pain scores (visual analogue scale (VAS)) with active 30 degrees flexion of the hip at 6 and 24 hours postoperatively. • Pain scores at rest (VAS) at 6 and 24 hours postoperatively. • Number of patients with one or more adverse events in the intervention period (0-24 hours) Exploratory end-points: • Level of nausea at 6 and 24 hours postoperatively. • Number of vomiting episodes (0-24 hours) measured in the periods 0-6 and 6-24 hours postoperatively • Consumption of ondansetron in the period 0-24 hours postoperatively • Level of sedation at 6 and 24 hours postoperatively • Level of dizziness at 6 and 24 hours postoperatively • Blood loss during the surgical procedure (intraoperatively) • Days alive and outside hospital within 90 days after surgery. ;Timepoint(s) of evaluation of this end point: - Pain scores, nausea, degree of sedation, at 6 and 24 hours postoperatively - Number of patiens with one or more AE, number of vomiting episodes, consumption of ondansetron, blood loss during the surgical procedure: at 24 hours postoperatively - Days alive and outside hospital: at 90 days postoperatively | — |
Countries
Denmark
Contacts
Public ContactDepartment of Anaesthesiology
Næstved Hospital
Outcome results
None listed