Osteoarthritis, Knee
Conditions
Keywords
periarticular multimodal drug injection
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.
Interventions
DRUGropivacaine
300mg (0.75%, 40cc) intraoperative periarticular injection
DRUGmorphine sulfate
10mg intraoperative periarticular injection
DRUGketorolac
30 mg intraoperative periarticular injection
DRUGepinephrine
300 microgram (1:1000) intraoperative periarticular injection
DRUGcefuroxime
750mg intraoperative periarticular injection
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 81 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Participant flow
Recruitment details
101 patients who were scheduled for unilateral total knee arthroplasty recruitment at Joint Reconstruction Center, Seoul National University Bundang hospital from April 2008 to March 2009 were recruited.
Pre-assignment details
no participant was excluded before assignment
Participants by arm
| Arm | Count |
|---|---|
| Periarticular Injection Group Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime | 49 |
| No Injection Group usual postoperative care without periarticular injection | 52 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | disconnection of catheter | 4 | 8 |
| Overall Study | disconnection of drain | 0 | 1 |
| Overall Study | peroneal nerve palsy | 0 | 1 |
Baseline characteristics
| Characteristic | Periarticular Injection Group | Total | No Injection Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 40 Participants | 84 Participants | 44 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 17 Participants | 8 Participants |
| Age Continuous | 70.2 years STANDARD_DEVIATION 7.1 | 70.1 years STANDARD_DEVIATION 6.1 | 70.1 years STANDARD_DEVIATION 4.9 |
| Region of Enrollment Korea, Republic of | 49 participants | 101 participants | 52 participants |
| Sex: Female, Male Female | 44 Participants | 92 Participants | 48 Participants |
| Sex: Female, Male Male | 5 Participants | 9 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 52 |
| serious Total, serious adverse events | 0 / 49 | 0 / 52 |
Outcome results
Primary
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.
Time frame: the night after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Periarticular Injection Group | Pain( Visual Analog Scale ) | 2.3 units on a scale | Standard Deviation 3.2 |
| No Injection Group | Pain( Visual Analog Scale ) | 6.4 units on a scale | Standard Deviation 3.4 |
Secondary
Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery
Fentanyl based PCA consumption via PCA pump (microgram)
Time frame: 24 hours postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Periarticular Injection Group | Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery | 169.4 microgram | Standard Deviation 273.9 |
| No Injection Group | Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery | 262.3 microgram | Standard Deviation 200.2 |
Secondary
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
Time frame: postoperative 7 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Periarticular Injection Group | Maximal Flexion Angle Degree on Postoperative 7 Day | 92.3 degree | Standard Deviation 17.3 |
| No Injection Group | Maximal Flexion Angle Degree on Postoperative 7 Day | 95.2 degree | Standard Deviation 13.7 |
Secondary
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.
Time frame: 24 hours after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Periarticular Injection Group | Participant Number of Postoperative Nausea and Vomiting During 24 Hours After Surgery | 22 participants |
| No Injection Group | Participant Number of Postoperative Nausea and Vomiting During 24 Hours After Surgery | 15 participants |
Secondary
The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended
Time frame: 24 hours postoperative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Periarticular Injection Group | The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended | 18 participants |
| No Injection Group | The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended | 6 participants |
Secondary
the Proportion of Patients Who Were Satisfied With the Pain Management
Time frame: postoperative 7 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Periarticular Injection Group | the Proportion of Patients Who Were Satisfied With the Pain Management | 38 participants |
| No Injection Group | the Proportion of Patients Who Were Satisfied With the Pain Management | 39 participants |