Periarticular Multimodal Drug Injections in Total Knee Arthroplasty
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ClinicalTrials.gov Identifier: NCT00901628 |
Recruitment Status
:
Completed
First Posted
: May 14, 2009
Results First Posted
: January 25, 2013
Last Update Posted
: January 25, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis, Knee | Drug: ropivacaine Drug: morphine sulfate Drug: ketorolac Drug: epinephrine Drug: cefuroxime | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 101 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of Periarticular Multimodal Drug Injections in Total Knee Arthroplasty |
Study Start Date : | April 2008 |
Actual Primary Completion Date : | March 2009 |
Actual Study Completion Date : | April 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Periarticular Injection group
Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
|
Drug: ropivacaine
300mg (0.75%, 40cc) intraoperative periarticular injection
Drug: morphine sulfate
10mg intraoperative periarticular injection
Drug: ketorolac
30 mg intraoperative periarticular injection
Drug: epinephrine
300 microgram (1:1000) intraoperative periarticular injection
Drug: cefuroxime
750mg intraoperative periarticular injection
|
No Intervention: No Injection group
usual postoperative care without periarticular injection
|
- Pain( Visual Analog Scale ) [ Time Frame: the night after surgery ]An independent investigator who was blinded to randomization assessed pain level using 0 to 10 visual analog scale (VAS) that ranged from 0 (no pain) to 10 (worst imaginable pain)at the night after operation.
- Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery [ Time Frame: 24 hours postoperative ]Fentanyl based PCA consumption via PCA pump (microgram)
- Participant Number of Postoperative Nausea and Vomiting During 24 Hours After Surgery [ Time Frame: 24 hours after surgery ]An independent investigator assessed participant number of postoperative nausea and vomiting during 24 hours after surgery. Nausea was defined as a subjective unpleasant sensation associated with awareness of the urge to vomit; and vomiting, as the forceful expulsion of gastric contents from the mouth.
- the Proportion of Patients Who Were Satisfied With the Pain Management [ Time Frame: postoperative 7 day ]
- The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended [ Time Frame: 24 hours postoperative ]
- Maximal Flexion Angle Degree on Postoperative 7 Day [ Time Frame: postoperative 7 day ]An independent investigator measured the maximal flexion angle (degree) of replaced knee with 28 centimeter armed goniometer on postoperative 7 day

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Ages Eligible for Study: | 18 Years to 81 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of primary osteoarthritis
- Scheduled for elective total knee arthroplasty
- Signed written informed consent
- Spinal anesthesia
Exclusion Criteria:
- Patients refusing consents
- inability to use the outcome assessment tools
- Contraindications to regional anesthesia
- severe cardiovascular disease
- allergy or contraindication to drugs used in this study
- pre-existing neurologic disease including psychiatric disorder
- drug abuser

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): NCT00901628
Korea, Republic of | |
Joint Reconstruction Center, Seoul National University Bundang Hospital | |
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707 |
Principal Investigator: | Tae Kyun Kim, MD, PhD | Joint Recontruction Center, Seoul National University Bundang hospital |
Responsible Party: | Tae Kyun Kim, Joint reconstruction center, Dept. of orthopaedic surgery, Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT00901628 History of Changes |
Other Study ID Numbers: |
B-0804/056-021 |
First Posted: | May 14, 2009 Key Record Dates |
Results First Posted: | January 25, 2013 |
Last Update Posted: | January 25, 2013 |
Last Verified: | December 2012 |
Keywords provided by Tae Kyun Kim, Seoul National University Hospital:
periarticular multimodal drug injection |
Additional relevant MeSH terms:
Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Morphine Ketorolac Ketorolac Tromethamine Ropivacaine Epinephrine Racepinephrine Epinephryl borate Cefuroxime Cefuroxime axetil |
Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Local Anesthetics Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic beta-Agonists |