Acute postoperative pain after hip arthroplasty MedDRA version: 20.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863 MedDRA version: 20.0 Level: PT Classification code 10020096 Term: Hip arthroplasty System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: Paracetamol
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Paracetamol
Other descriptive name: PARACETAMOL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
Sponsors
Daniel Hägi-Pedersen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Scheduled for elective, unilateral, primary total hip arthroplasty • Age = 18 • ASA 1-3 • BMI > 18 and =65 years) no F.1.3.1 Number of subjects for this age range 636
Exclusion criteria
Exclusion criteria: • Patients who cannot cooperate with the trial • Concomitant participation in another trial involving medication • Patients who cannot understand or speak Danish • Patients with allergy to medication used in the trial • Patients with daily use of high dose opioid (> oral morphine 30 mg/day or oxycodone 30 mg/day or tramadol 150 mg/day) or any use of other opioids including methadone and transdermal opioids. • Patients with daily use of systemic glucocorticoids (within 3 months before the trial) • Contraindications against ibuprofen or paracetamol, for example previous ulcer, known heart failure, known liver failure, or known renal failure (eGRF < 60 ml/kg/1,73m2), known thrombocytopenia (< 100 x 109/l); or against treatment with glucocorticoids • Dysregulated diabetes (investigator’s judgement) • Patients suffering from alcohol and/or drug abuse – based on the investigator's judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To investigate the analgesic effect on pain levels during mobilization and at rest, of different combinations of paracetamol, ibuprofen, and dexamethasone. To investigate the analgesic effect on pain levels during walk (5 meters) at 24-hours postoperatively, of different combinations of paracetamol, ibuprofen, and dexamethasone. To investigate number of patients with AEs of different combinations of paracetamol, ibuprofen, and dexamethasone ;Primary end point(s): Total need for IV-morphine mg (eqv) for the first 24 hours postoperatively, administered as patient-controlled analgesia (PCA)-morphine (0-24 hours), and supplemental opioid administered at the post-anaesthesia care unit the first hour postoperatively after end of surgery (general anaesthesia) or end of spinal anaesthesia, or any supplemental opioid given at the ward.;Main Objective: To investigate the analgesic effects, by differences in 24-hour morphine consumption, of different combinations of paracetamol, ibuprofen, and dexamethasone after total hip arthroplasty.;Timepoint(s) of evaluation of this end point: IV-equivalent morphine-consumption will be registered at 24 hours after end of surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Pain scores (visual analogue scale (VAS)) with active 30 degrees flexion of the hip at 24 hours postoperatively. ? • Pain scores at rest (VAS) at 24 hours postoperatively. ? • Maximum level of pain (VAS) during walk of 5 meters at 24 hours postoperatively. • Number of patients with one or more AEs in the intervention period (0-24 hours) ;Timepoint(s) of evaluation of this end point: • Pain scores (visual analogue scale (VAS)) with active 30 degrees flexion of the hip at 24 hours postoperatively. ? • Pain scores at rest (VAS) at 24 hours postoperatively. ? • Maximum level of pain (VAS) during walk of 5 meters at 24 hours postoperatively. • Number of patients with one or more AEs in the intervention period (0-24 hours) | — |
Countries
Denmark
Contacts
Public ContactDept of Anaesthesiology
Næstved Hospital
Outcome results
None listed