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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, University Hospital Orebro.
Recruitment status was:  Recruiting
First Posted : January 24, 2011
Last Update Posted : September 12, 2012
Information provided by (Responsible Party):
Per Essving, University Hospital Orebro

Brief Summary:

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : September 2009
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Pain intensity (NRS, Numeric Rating Score; 0-10) [ Time Frame: 0 - 24 h ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 60 - 80 year-old undergoing total hip arthroplasty.
  2. ASA I - II (appendix 1).
  3. Have signed and dated Informed Consent.
  4. Willing and able to comply with the protocol for the duration of the trial.

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.

Information from the National Library of Medicine

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    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         
Sponsors and Collaborators
Region Örebro County

Responsible Party: Per Essving, Assistant Professor, University Hospital Orebro
ClinicalTrials.gov Identifier: NCT01281891     History of Changes
Other Study ID Numbers: THA001
First Posted: January 24, 2011    Key Record Dates
Last Update Posted: September 12, 2012
Last Verified: September 2012

Keywords provided by Per Essving, University Hospital Orebro:
Drug: Morphine intrathecal
Pain: Postoperative
Surgery: Total hip arthroplasty

Additional relevant MeSH terms:
Pain, Postoperative
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents