COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Postoperative Pain Relief Following Total Hip Arthroplasty. A Comparison Between Intrathecal Morphine (IM) and Local Infiltration Analgesia (LIA) (HÖFTPLASTIK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Per Essving, Region Örebro County

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 Show detailed description

Layout table for study information
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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
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 identifier (NCT number): NCT01281891

Layout table for location information
Örebro University Hospital Recruiting
Örebro, Sweden, 70185
Contact: Anil Gupta, FRCA, PhD    +46 19 6020256   
Contact: Jan Kuchalik, MD    +46 19 6020317   
Principal Investigator: Anil Gupta, FRCA, PhD         
Sub-Investigator: Jan Kuchalik, MD         
Sponsors and Collaborators
Region Örebro County
Layout table for additonal information
Responsible Party: Per Essving, Assistant Professor, Region Örebro County Identifier: NCT01281891    
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, Region Örebro County:
Drug: Morphine intrathecal
Pain: Postoperative
Surgery: Total hip arthroplasty
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents