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.
Drug: morphine sulfate
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Periarticular Multimodal Drug Injections in Total Knee Arthroplasty|
- Pain( Visual Analog Scale ) [ Time Frame: the night after surgery ] [ Designated as safety issue: No ]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.
- Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]
- The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: No ]
- Maximal Flexion Angle Degree on Postoperative 7 Day [ Time Frame: postoperative 7 day ] [ Designated as safety issue: No ]An independent investigator measured the maximal flexion angle (degree) of replaced knee with 28 centimeter armed goniometer on postoperative 7 day
|Study Start Date:||April 2008|
|Study Completion Date:||April 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Experimental: Periarticular Injection group
Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
300mg (0.75%, 40cc) intraoperative periarticular injectionDrug: morphine sulfate
10mg intraoperative periarticular injectionDrug: ketorolac
30 mg intraoperative periarticular injectionDrug: epinephrine
300 microgram (1:1000) intraoperative periarticular injectionDrug: cefuroxime
750mg intraoperative periarticular injection
No Intervention: No Injection group
usual postoperative care without periarticular injection
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00901628
|Korea, Republic of|
|Joint Reconstruction Center, Seoul National University Bundang Hospital|
|Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707|
|Principal Investigator:||Tae Kyun Kim, MD, PhD||Joint Recontruction Center, Seoul National University Bundang hospital|