Efficacy and Safety of Periarticular Multimodal Drug Injections in Total Knee Arthroplasty
Overview
- Phase
- Phase 4
- Intervention
- ropivacaine
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Seoul National University Hospital
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- Pain( Visual Analog Scale )
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
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.
Investigators
Tae Kyun Kim
Joint reconstruction center, Dept. of orthopaedic surgery
Seoul National University Hospital
Eligibility 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
Arms & Interventions
Periarticular Injection group
Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
Intervention: ropivacaine
Periarticular Injection group
Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
Intervention: morphine sulfate
Periarticular Injection group
Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
Intervention: ketorolac
Periarticular Injection group
Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
Intervention: epinephrine
Periarticular Injection group
Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
Intervention: cefuroxime
Outcomes
Primary Outcomes
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 Outcomes
- Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery(24 hours postoperative)
- Participant Number of Postoperative Nausea and Vomiting During 24 Hours After Surgery(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(postoperative 7 day)