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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University Hospital Orebro
Sponsor:
Information provided by (Responsible Party):
Per Essving, University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT01281891
First received: January 20, 2011
Last updated: September 11, 2012
Last verified: September 2012
  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)

Resource links provided by NLM:


Further study details as provided by University Hospital Orebro:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281891

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         
Sponsors and Collaborators
University Hospital Orebro
  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
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014