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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
Sponsor:
Information provided by (Responsible Party):
Tae Kyun Kim, Seoul National University Hospital

Study Description
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Brief Summary:
The purpose of this study is to determine whether periarticular multimodal drug injection (PMDI) would provide additional benefits in patients after total knee arthroplasty (TKA) for whom contemporary pain control protocols using the continuous femoral nerve block, intra-venous patient controlled analgesia (IV-PCA)and preemptive oral medications. We hypothesized that PMDI would reduce pain level and consumption of PCA and acute pain rescuer and would provide better functional recovery and patient satisfaction. We also hypothesized that the incidence of side effects and complications of the PMDI would be similar to the No-PMDI.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: ropivacaine Drug: morphine sulfate Drug: ketorolac Drug: epinephrine Drug: cefuroxime Phase 4

Detailed Description:
The preemptive multimodal approaches are regarded as a current standard pain management protocol. Recently, periarticular multimodal drug injection (PMDI) has been considered to be one of the most effective and important component in multimodal approaches. Because the contemporary pain management protocol using the regional anesthesia, continuous femoral nerve block (FNB) and intravenous patient-controlled analgesia (PCA) has been proved significantly improved analgesic effects itself, little information whether the PMDI would provide additional pain relief under this pain management protocol is available. Also, because the safety of the high dose local anesthetics and narcotics has not been clarified, a selective application should be considered to patients who were expected to show better analgesia if there were certain patient related factors to predict the additional pain relief effect of the PMDI. Thus, this prospective double-blind randomized study was conducted to determine whether PMDI would provide additional benefits in patients after total knee arthroplasty (TKA) for whom contemporary pain control protocols using the continuous femoral nerve block, IV-PCA and preemptive oral medications in terms of pain relief, consumption of PCA and acute pain rescuer, patients satisfaction, functional recovery, side effects and complications.

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery [ Time Frame: 24 hours postoperative ]
    Fentanyl based PCA consumption via PCA pump (microgram)

  2. 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.

  3. the Proportion of Patients Who Were Satisfied With the Pain Management [ Time Frame: postoperative 7 day ]
  4. The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended [ Time Frame: 24 hours postoperative ]
  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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): NCT00901628


Locations
Korea, Republic of
Joint Reconstruction Center, Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Tae Kyun Kim, MD, PhD Joint Recontruction Center, Seoul National University Bundang hospital
More Information
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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