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
|Condition or disease||Intervention/treatment||Phase|
|Arthroplasty, Replacement, Hip||Drug: Epidural Ropivacaine, morphine Drug: Ropivacaine, Ketorolac and Adrenaline||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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
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
- Consumption af analgesics [ Time Frame: 96 h ]
- Side effects [ Time Frame: 96 h ]
- Mobilization level [ Time Frame: 8 h ]
- Pain scores VAS [ Time Frame: 96 h ]
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
|Orthopedic Center, Aarhus University Hospital|
|Aarhus, Denmark, 8000|
|Principal Investigator:||Kjeld Søballe, Professor||Orthopedic Center, Aarhus University Hospital, Aarhus, Denmark|