Postoperative Pain Relief Following Total Hip Arthroplasty. A Comparison Between Intrathecal Morphine (IM) and Local Infiltration Analgesia (LIA) (HÖFTPLASTIK)
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|ClinicalTrials.gov Identifier: NCT01281891|
Recruitment Status : Unknown
Verified September 2012 by Per Essving, Region Örebro County.
Recruitment status was: Recruiting
First Posted : January 24, 2011
Last Update Posted : September 12, 2012
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 or disease||Intervention/treatment||Phase|
|Primary Osteoarthritis Requiring Total Hip Replacement||Drug: LIA Drug: I/T morphine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Postoperative Pain Relief Following Total Hip Arthroplasty. A Comparison Between Intrathecal Morphine (IM) and Local Infiltration Analgesia (LIA)|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||September 2012|
|Estimated Study Completion Date :||September 2012|
Experimental: Local Infiltration Analgesia
Combination of ropivacaine, ketorolac and adrenaline
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
- Total morphine consumption postoperatively [ Time Frame: During 0 -24 hours postoperatively ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01281891
|Örebro University Hospital||Recruiting|
|Örebro, Sweden, 70185|
|Contact: Anil Gupta, FRCA, PhD +46 19 6020256 firstname.lastname@example.org|
|Contact: Jan Kuchalik, MD +46 19 6020317 email@example.com|
|Principal Investigator: Anil Gupta, FRCA, PhD|
|Sub-Investigator: Jan Kuchalik, MD|