Postoperative pain relief following total hip arthroplasty. A comparison between 3-in-1 blockade (single shot) with ultrasound placement and local infiltration analgesia.
- Conditions
- Postoperative pain relief after total hip arthroplastyMedDRA version: 14.1Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2012-003875-20-SE
- Lead Sponsor
- niversitetssjukhuset Örebro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Are there any differences in postoperative movement pain between LIA and 3-in-1blockade 24 hours after surgery?<br><br>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 Outcome Measures
Name Time Method 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. <br>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<br><br>Mobilization: during the first 24 postoperative hours <br><br>Time to hospital discharge: When it occurs<br>Health-related quality of life: 3 and 6 months after surgery<br>;Secondary end point(s): Postoperative pain<br>Patient experienced pain relief <br>Mobilization after 24 hours<br>Time to hospital discharge<br>Health-related quality of life and pain after 3 months (10-14 weeks) and 6 months (± 2 weeks)<br>