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Intraarticular Analgesia After Total Hip Arthroplasty, a Randomised Study

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ClinicalTrials.gov Identifier: NCT00289419
Recruitment Status : Completed
First Posted : February 9, 2006
Last Update Posted : May 7, 2008
Sponsor:
Information provided by:
University of Aarhus

Study Description
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Brief Summary:
The purpose of this study is to determine whether wound infiltration with following single-shot bolus injection with local anesthetic and NASIDs are effective in the treatment of postoperative pain after total hip replacement compared to continuous epidural infusion.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Hip Drug: Epidural Ropivacaine, morphine Drug: Ropivacaine, Ketorolac and Adrenaline Phase 4

Detailed Description:

Sufficient postoperative pain relief after total hip replacement is necessary to achieve normal mobilisation and a reduction of the surgical stress response. After total hip replacement epidural treatment has proven superior, with regards to pain relief, than treatment with parenteral infusions and periphery nerve blocks. Even though epidural treatment gives excellent pain relief adverse effect as motor block, urine retention, hypotension and itching occurs regularly which delays rehabilitation.

Treatment with the administration of local anesthetic in the operating field has shown its efficiency in reducing postoperative pain with a low incidence of adverse effects after various surgical procedures.

This study compares continuous epidural infusion of ropivacaine added morphine to a new technique, where ropivacaine, ketorolac and adrenaline is used to infiltrate the tissue around the hip joint during surgery, and is injected by an intraarticular catheter 8 hours postoperative.

Data of pain scores, analgesia consumption, adverse effects and mobilisation is collected for the first 4 postoperative days.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Postoperative Analgesia After Total Hip Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Intraarticular Bolus Injection.
Study Start Date : February 2005
Actual Primary Completion Date : February 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A Drug: Epidural Ropivacaine, morphine
Infusion rate 4 ml/h in 48 h Solution 200 ml Ropivacaine 2mg/ml added 1 ml morphine 10 mg/ml
Experimental: B Drug: Ropivacaine, Ketorolac and Adrenaline
Wound infiltration: 100 ml Ropivacaine 2 mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml adrenaline 1 mg/ml Bolus injection: 20 ml Ropivacaine 7,5mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml adrenaline 1 mg/ml


Outcome Measures
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Primary Outcome Measures :
  1. Consumption af analgesics [ Time Frame: 96 h ]

Secondary Outcome Measures :
  1. Side effects [ Time Frame: 96 h ]
  2. Mobilization level [ Time Frame: 8 h ]
  3. Pain scores VAS [ Time Frame: 96 h ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients admitted consecutively to primary total hip arthroplasty due to arthrosis

Exclusion Criteria:

  • Patients unable to provide informed consent
  • Patients with contraindications for spinal anesthesia
  • Patients with known hypersensitivity towards the used drugs
  • Patients with severe chronic neurogenic pain
  • Patients with Rheumatoid arthritis
  • Patients with a daily opioid consumption
Contacts and Locations
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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): NCT00289419


Locations
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Denmark
Orthopedic Center, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Kjeld Søballe, Professor Orthopedic Center, Aarhus University Hospital, Aarhus, Denmark
More Information
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Responsible Party: Professor Kjeld Soballe, University of Aarhus
ClinicalTrials.gov Identifier: NCT00289419    
Other Study ID Numbers: 20040199
First Posted: February 9, 2006    Key Record Dates
Last Update Posted: May 7, 2008
Last Verified: May 2008
Keywords provided by University of Aarhus:
Arthroplasty, Replacement, Hip
Anesthetics, Local
Pain, Postoperative
Additional relevant MeSH terms:
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Ketorolac
Epinephrine
Racepinephrine
Morphine
Ropivacaine
Epinephryl borate
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents