Postoperative Pain Relief following Total Hip Arthroplasty. A comparison between Intrathecal morphine (IM) and Local Infiltration Analgesia (LIA).
- Conditions
- Postoperative pain following total hip arthroplasty
- Registration Number
- EUCTR2008-008723-15-SE
- Lead Sponsor
- Örebro University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1.50 - 85 year-old undergoing total hip arthroplasty.
2.ASA I – II.
3.Have signed and dated Informed Consent.
4.Willing and able to comply with the protocol for the duration of the trial.
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
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: To evaluate whether intraoperative administration of ropivacaine, ketorolac and epinephrine into the operating field during THA will provide similar analgesia during 0-24 hours compared to spinal morphine<br>;Secondary Objective: To assess: postoperative pain and analgesic consumption, mobilization, home readiness and home discharge, post-discharge pain and its management, health-related quality of life and outcome during the first 6 months following THA surgery. <br><br>;Primary end point(s): Total morphine consumption during 0 –24 hours postoperatively
- Secondary Outcome Measures
Name Time Method