Postoperative pain relief after total hip arthroplasty MedDRA version: 14.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Narop
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ropivakainhydroklorid
Other descriptive name: ROPIVACAINE HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentra
Sponsors
Universitetssjukhuset Örebro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 50 - 80 year-old patient undergoing total hip arthroplasty. 2. ASA I – III 3. Signed and dated Informed Consent. 4. The patient is willing and able to comply with the protocol 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 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Re-operation of a previous total hip arthroplasty. 2. Allergy/intolerance to local anaesthetics, Morphine, Adrenaline, Ketorolac or Ropivacaine. 3. Serious liver- or renal disease judged by the investigator to be of such dignity as to prevent inclusion into the study. 4. Serious heart disease judged by the investigator to be of such dignity as to prevent inclusion into the study, 5. Patients with chronic pain who are taking opiate analgesics regularly. 6. Major bleeding disorders 7. Chronic obstructive pulmonary disease (COPD) 8. Severe asthma that is difficult to treat 9. Limited breathing capacity due to muscular dystrophy 10. Sleep apnoea syndrome 11. Other contraindication to spinal anaesthesia such as spinal stenosis, local infection or contraindications to local anaesthetics. 12. Participation in another clinical medicinal trial during the last 30 days or where follow-up is not completed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Are there any differences in postoperative movement pain between LIA and 3-in-1blockade 24 hours after surgery? Might the origin of chronic pain be reduced by the choice of LIA technique?;Secondary Objective: Are there any differences in postoperative pain in rest, total morphine consumption, patient experienced pain relieved, mobilization, time to hospital discharge and health related quality of life between the groups?;Primary end point(s): Total morphine consumption during 24 postoperative hours following hip arthroplasty.;Timepoint(s) of evaluation of this end point: During 24 postoperative hours following hip arthroplasty | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Postoperative pain and patient experienced pain relief: Will be registered 4, 8, 23, 24, 36 and 48 hours following surgery, every 24th hour until discharge and after 3 and 6 months. The patient will also assess pain daily up to 14 days after the surgery and weekly 3 and 4 weeks after surgery. If NRS > 2-3 at 6 months follow-up, BPI-SF will also be performed after 12 months Mobilization: during the first 24 postoperative hours Time to hospital discharge: When it occurs Health-related quality of life: 3 and 6 months after surgery ;Secondary end point(s): Postoperative pain Patient experienced pain relief Mobilization after 24 hours Time to hospital discharge Health-related quality of life and pain after 3 months (10-14 weeks) and 6 months (± 2 weeks) | — |
Countries
Sweden
Contacts
Public ContactAnil Gupta
Universitetssjukhuset Örebro
Outcome results
None listed