Periarticular Multimodal Drug Injections in Total Knee Arthroplasty

Overview

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.

Full Title of Study: “Efficacy and Safety of Periarticular Multimodal Drug Injections in Total Knee Arthroplasty”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 2009

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Periarticular Injection group
    • Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
  • No Intervention: No Injection group
    • usual postoperative care without periarticular injection

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 81 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tae Kyun Kim, Joint reconstruction center, Dept. of orthopaedic surgery – Seoul National University Hospital
  • Overall Official(s)
    • Tae Kyun Kim, MD, PhD, Principal Investigator, Joint Recontruction Center, Seoul National University Bundang hospital

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