Postoperative Pain Relief Following Total Hip Arthroplasty. A Comparison Between Intrathecal Morphine (IM) and Local Infiltration Analgesia (LIA) (HÖFTPLASTIK)
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Purpose
Postoperative pain following total hip arthroplasty (THA) (1) is often considered moderate to severe and can therefore influence the postoperative course of event and result in delayed postoperative mobilization and prolonged hospitalization. It is therefore necessary to find the most optimal method for alleviation of pain for these patients. Traditionally, this has been managed by epidural analgesia, continuous peripheral nerve blocks, parental- or spinal opioids. Recently, Drs Kerr and Kohan at the Joint Orthopaedic Centre in Sydney, Australia developed a local infiltration analgesia (LIA) technique. The technique was introduced in Scandinavia during 2001 and has been shown to be efficacious during knee surgery. The LIA technique is based on a systemic infiltration of a mixture of a long-acting local anaesthetic (ropivacaine), a non steroidal anti-inflammatory drug (ketorolac), and epinephrine into the tissue around the surgical field to achieve satisfactory pain control with little physiological disturbance. A catheter is left from the skin and into the joint cavity, allowing repeated injection on the morning after surgery (10). Effective pain relief with early mobilization and reduced hospital stay has been reported following total knee arthroplasty and, recently, following unicompartmental knee arthroplasty.
The aim of this study is to assess whether LIA technique is equi-efficacious to intrathecal morphine, the standard of care in our hospital.
| Condition | Intervention | Phase |
|---|---|---|
|
Primary Osteoarthritis Requiring Total Hip Replacement |
Drug: LIA Drug: I/T morphine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Postoperative Pain Relief Following Total Hip Arthroplasty. A Comparison Between Intrathecal Morphine (IM) and Local Infiltration Analgesia (LIA) |
- Total morphine consumption postoperatively [ Time Frame: During 0 -24 hours postoperatively ] [ Designated as safety issue: Yes ]Other than total morphine consumption, even pain intensity on movement would be considered to be an important parallel end-point.
- Pain intensity (NRS, Numeric Rating Score; 0-10) [ Time Frame: 0 - 24 h ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Local Infiltration Analgesia
Combination of ropivacaine, ketorolac and adrenaline
|
Drug: LIA
Ropivacaine 0.2% Ketorolac 30 mg Adrenaline 0.1 mg/ml
|
|
Active Comparator: Intrathecal morphine
Morphine special (preservative-free) injected intrathecally
|
Drug: I/T morphine
Morphine special 0.1 mg injected intrathecally
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 50 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 60 - 80 year-old undergoing total hip arthroplasty.
- ASA I - II (appendix 1).
- Have signed and dated Informed Consent.
- Willing and able to comply with the protocol for the duration of the trial.
Exclusion Criteria:
- Re-operation of a previous total hip arthroplasty.
- Allergy/intolerance to local anaesthetics, Morphine, Adrenaline, Ketorolac or Ropivacaine.
- Serious liver- or renal disease judged by the investigator to be of such dignity as to prevent inclusion into the study.
- Serious heart disease judged by the investigator to be of such dignity as to prevent inclusion into the study,
- Patients with chronic pain who are taking opiate analgesics regularly.
- Major bleeding disorders
- Chronic obstructive pulmonary disease (COPD)
- Severe asthma that is difficult to treat
- Limited breathing capacity due to muscular dystrophy
- Sleep apnoea syndrome
- Other contraindication to spinal anaesthesia such as spinal stenosis, local infection or contraindications to local anaesthetics.
- Participation in another clinical medicinal trial during the last 30 days or where follow-up is not completed.
Contacts and Locations| Sweden | |
| Örebro University Hospital | Recruiting |
| Örebro, Sweden, 70185 | |
| Contact: Anil Gupta, FRCA, PhD +46 19 6020256 anil.gupta@orebroll.se | |
| Contact: Jan Kuchalik, MD +46 19 6020317 jan.kuchalik@orebroll.se | |
| Principal Investigator: Anil Gupta, FRCA, PhD | |
| Sub-Investigator: Jan Kuchalik, MD | |
More Information
No publications provided
| Responsible Party: | Per Essving, Assistant Professor, University Hospital Orebro |
| ClinicalTrials.gov Identifier: | NCT01281891 History of Changes |
| Other Study ID Numbers: | THA001 |
| Study First Received: | January 20, 2011 |
| Last Updated: | September 11, 2012 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by University Hospital Orebro:
|
Drug: Morphine intrathecal Pain: Postoperative Surgery: Total hip arthroplasty |
Additional relevant MeSH terms:
|
Osteoarthritis Pain, Postoperative Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Postoperative Complications Pathologic Processes Pain Signs and Symptoms Morphine |
Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics |
ClinicalTrials.gov processed this record on May 23, 2013