Periarticular Multimodal Drug Injections in Total Knee Arthroplasty
- Conditions
- Osteoarthritis, Knee
- Interventions
- Registration Number
- NCT00901628
- Lead Sponsor
- Seoul National University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- Diagnosis of primary osteoarthritis
- Scheduled for elective total knee arthroplasty
- Signed written informed consent
- Spinal anesthesia
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Periarticular Injection group ropivacaine Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime Periarticular Injection group morphine sulfate Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime Periarticular Injection group epinephrine Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime Periarticular Injection group cefuroxime Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime Periarticular Injection group ketorolac Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
- Primary Outcome Measures
Name Time Method Pain( Visual Analog Scale ) 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 Outcome Measures
Name Time Method Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery 24 hours postoperative Fentanyl based PCA consumption via PCA pump (microgram)
Participant Number of Postoperative Nausea and Vomiting During 24 Hours After Surgery 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 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 An independent investigator measured the maximal flexion angle (degree) of replaced knee with 28 centimeter armed goniometer on postoperative 7 day
Trial Locations
- Locations (1)
Joint Reconstruction Center, Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of