Periarticular Multimodal Drug Injections in Total Knee Arthroplasty

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 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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: ropivacaine; Drug: morphine sulfate; Drug: ketorolac; Drug: epinephrine; Drug: cefuroxime

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 Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Joint Reconstruction Center, Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain( Visual Analog Scale )	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.	the night after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery	Fentanyl based PCA consumption via PCA pump (microgram)	24 hours postoperative
Participant Number of Postoperative Nausea and Vomiting During 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.	24 hours after surgery
the Proportion of Patients Who Were Satisfied With the Pain Management		postoperative 7 day
The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended		24 hours postoperative
Maximal Flexion Angle Degree on Postoperative 7 Day	An independent investigator measured the maximal flexion angle (degree) of replaced knee with 28 centimeter armed goniometer on postoperative 7 day	postoperative 7 day

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Tae Kyun Kim, MD, PhD, Joint Recontruction Center, Seoul National University Bundang hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: May 13, 2009
• First Submitted That Met QC Criteria: May 13, 2009
• First Posted (Estimate): May 14, 2009

Study Record Updates

• Last Update Posted (Estimate): January 25, 2013
• Last Update Submitted That Met QC Criteria: December 15, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: periarticular multimodal drug injection
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Adrenergic alpha-Agonists; Adrenergic Agonists; Anti-Bacterial Agents; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Ketorolac; Ropivacaine; Morphine; Epinephrine; Cefuroxime; Cefuroxime axetil
• Other Study ID Numbers: B-0804/056-021