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Periarticular Multimodal Drug Injections in Total Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tae Kyun Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00901628
First received: May 13, 2009
Last updated: December 15, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Osteoarthritis, Knee
Drug: ropivacaine
Drug: morphine sulfate
Drug: ketorolac
Drug: epinephrine
Drug: cefuroxime
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Periarticular Multimodal Drug Injections in Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Pain( Visual Analog Scale ) [ Time Frame: the night after surgery ] [ Designated as safety issue: No ]
    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:
  • Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: No ]
  • Maximal Flexion Angle Degree on Postoperative 7 Day [ Time Frame: postoperative 7 day ] [ Designated as safety issue: No ]
    An independent investigator measured the maximal flexion angle (degree) of replaced knee with 28 centimeter armed goniometer on postoperative 7 day


Enrollment: 101
Study Start Date: April 2008
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 81 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 13, 2009
Results First Received: May 15, 2009
Last Updated: December 15, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
periarticular multimodal drug injection

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Cefuroxime
Epinephrine
Ketorolac
Morphine
Ropivacaine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Analgesics
Analgesics, Non-Narcotic
Analgesics, Opioid
Anesthetics
Anesthetics, Local
Anti-Asthmatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2014