- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00289419
Intraarticular Analgesia After Total Hip Arthroplasty, a Randomised Study
Postoperative Analgesia After Total Hip Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Intraarticular Bolus Injection.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Aarhus, Denmark, 8000
- Orthopedic Center, Aarhus University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
|
Infusion rate 4 ml/h in 48 h Solution 200 ml Ropivacaine 2mg/ml added 1 ml morphine 10 mg/ml
|
Experimental: B
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Consumption af analgesics
Time Frame: 96 h
|
96 h
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Side effects
Time Frame: 96 h
|
96 h
|
Mobilization level
Time Frame: 8 h
|
8 h
|
Pain scores VAS
Time Frame: 96 h
|
96 h
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kjeld Søballe, Professor, Orthopedic Center, Aarhus University Hospital, Aarhus, Denmark
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Analgesics, Opioid
- Narcotics
- Anesthetics, Local
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Ketorolac
- Ropivacaine
- Morphine
- Epinephrine
- Racepinephrine
- Epinephryl borate
Other Study ID Numbers
- 20040199
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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