Periarticular Multimodal Drug Injections in Total Knee Arthroplasty

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

The purpose of this study is to determine whether periarticular multimodal drug injection (PMDI) would provide additional benefits in patients after TKA for whom contemporary pain control protocols using the continuous femoral nerve block, 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.

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 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.

Intervention(s) in this Clinical Trial

• Drug: ropivacaine
  • 300mg (0.75%, 40cc) intraoperative periarticular injection
• Other: No-PMDI
  • usual postoperative care without 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 in this Clinical Trial

• Experimental: PMDI group
  • Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
• Other: No-PMDI group
  • usual postoperative care without periarticular injection

Primary Measures

• pain(VAS)
  • Time Frame: operation night & 24 hours postoperative
    Safety Issue?: No

Secondary Measures

• patient satisfaction
  • Time Frame: postoperative 7 day
    Safety Issue?: No
• incidence of side effects & complications
  • Time Frame: operation night, postoperative 1day & 4 day
    Safety Issue?: Yes
• PCA & acute pain rescuer consumption
  • Time Frame: 24 hours postoperative
    Safety Issue?: No
• ability to SLR
  • Time Frame: 24 hours postoperative
    Safety Issue?: No
• ROM
  • Time Frame: postoperative 7 day
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 81 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Seoul National University Hospital Other

Overall Clinical Trial Officials and Contacts

Tae Kyun Kim, MD, PhD Principal Investigator Joint Recontruction Center, Seoul National University Bundang hospital  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00901628

Study ID Number: B-0804/056-021

ClinicalTrials.gov Identifier: NCT00901628

Health Authority: Korea: Food and Drug Administration