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| Sponsored by: |
University of Aarhus |
|---|---|
| Information provided by: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT00289419 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Arthroplasty, Replacement, Hip |
Drug: Epidural Ropivacaine, morphine Drug: Ropivacaine, Ketorolac and Adrenaline |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Postoperative Analgesia After Total Hip Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Intraarticular Bolus Injection. |
| Enrollment: | 80 |
| Study Start Date: | February 2005 |
| Study Completion Date: | March 2006 |
| Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| A: Active Comparator |
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
|
| B: Experimental |
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Denmark | |
| Orthopedic Center, Aarhus University Hospital | |
| Aarhus, Denmark, 8000 | |
| Principal Investigator: | Kjeld Søballe, Professor | Orthopedic Center, Aarhus University Hospital, Aarhus, Denmark |
More Information
| Responsible Party: | University of Aarhus ( Professor Kjeld Soballe ) |
| Study ID Numbers: | 20040199 |
| Study First Received: | February 8, 2006 |
| Last Updated: | May 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00289419 History of Changes |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
|
Arthroplasty, Replacement, Hip Anesthetics, Local Pain, Postoperative |
|
Anti-Inflammatory Agents Neurotransmitter Agents Adrenergic Agents Ketorolac Anesthetics Pain Adrenergic Agonists Vasoconstrictor Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics Epinephrine Pain, Postoperative Analgesics, Opioid Morphine Adrenergic alpha-Agonists |
Adrenergic beta-Agonists Ropivacaine Cyclooxygenase Inhibitors Anti-Asthmatic Agents Central Nervous System Depressants Narcotics Cardiovascular Agents Anesthetics, Local Mydriatics Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Ketorolac Tromethamine Bronchodilator Agents |
|
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Ketorolac Anesthetics Adrenergic Agonists Sensory System Agents Therapeutic Uses Vasoconstrictor Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics Epinephrine |
Analgesics, Opioid Morphine Adrenergic alpha-Agonists Adrenergic beta-Agonists Sympathomimetics Ropivacaine Cyclooxygenase Inhibitors Central Nervous System Depressants Anti-Asthmatic Agents Enzyme Inhibitors Narcotics Cardiovascular Agents Anesthetics, Local Pharmacologic Actions Mydriatics |
