Periarticular Multimodal Drug Injections in Total Knee Arthroplasty
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ropivacaine
morphine sulfate
ketorolac
epinephrine
cefuroxime
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring periarticular multimodal drug injection
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
Sites / Locations
- Joint Reconstruction Center, Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Periarticular Injection group
No Injection group
Arm Description
Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
usual postoperative care without periarticular injection
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery
Fentanyl based PCA consumption via PCA pump (microgram)
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.
the Proportion of Patients Who Were Satisfied With the Pain Management
The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended
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
Full Information
NCT ID
NCT00901628
First Posted
May 13, 2009
Last Updated
December 15, 2012
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00901628
Brief Title
Periarticular Multimodal Drug Injections in Total Knee Arthroplasty
Official Title
Efficacy and Safety of Periarticular Multimodal Drug Injections in Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
periarticular multimodal drug injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Periarticular Injection group
Arm Type
Experimental
Arm Description
Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
Arm Title
No Injection group
Arm Type
No Intervention
Arm Description
usual postoperative care without periarticular injection
Intervention Type
Drug
Intervention Name(s)
ropivacaine
Intervention Description
300mg (0.75%, 40cc) intraoperative periarticular injection
Intervention Type
Drug
Intervention Name(s)
morphine sulfate
Intervention Description
10mg intraoperative periarticular injection
Intervention Type
Drug
Intervention Name(s)
ketorolac
Intervention Description
30 mg intraoperative periarticular injection
Intervention Type
Drug
Intervention Name(s)
epinephrine
Intervention Description
300 microgram (1:1000) intraoperative periarticular injection
Intervention Type
Drug
Intervention Name(s)
cefuroxime
Intervention Description
750mg intraoperative periarticular injection
Primary Outcome Measure Information:
Title
Pain( Visual Analog Scale )
Description
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.
Time Frame
the night after surgery
Secondary Outcome Measure Information:
Title
Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery
Description
Fentanyl based PCA consumption via PCA pump (microgram)
Time Frame
24 hours postoperative
Title
Participant Number of Postoperative Nausea and Vomiting During 24 Hours After Surgery
Description
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.
Time Frame
24 hours after surgery
Title
the Proportion of Patients Who Were Satisfied With the Pain Management
Time Frame
postoperative 7 day
Title
The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended
Time Frame
24 hours postoperative
Title
Maximal Flexion Angle Degree on Postoperative 7 Day
Description
An independent investigator measured the maximal flexion angle (degree) of replaced knee with 28 centimeter armed goniometer on postoperative 7 day
Time Frame
postoperative 7 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae Kyun Kim, MD, PhD
Organizational Affiliation
Joint Recontruction Center, Seoul National University Bundang hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joint Reconstruction Center, Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Periarticular Multimodal Drug Injections in Total Knee Arthroplasty
We'll reach out to this number within 24 hrs