Osteoarthritis of the Knee
Conditions
Keywords
osteoarthritis, knee arthroplasty, local infiltration analgesia, TKA, epidural analgesia, operation, surgery
Brief summary
Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge. The aim of this study is to: 1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty. 2. Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.
Detailed description
Total knee arthroplasty (TKA) is increasingly common in the treatment of knee osteoarthritis. TKA is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge. Continuous epidural analgesia is often used for controlling pain after TKA. Recent studies describe a new method for pain control after total knee arthroplasty which consists of local infiltration with local anesthetics and adrenaline. This infiltrations can be combined with ketorolac and/or morphine. The aim of this study is to: 1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty. 2. Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.
Interventions
DRUGropivacaine
intraoperative and 1. postoperative day
DRUGadrenaline
intraoperative LIA (IV and IA) and continuous EDA
DRUGketorolac
intraoperative and 1. postoperative day
DRUGmorphine
intraoperative
DRUGfentanyl
continuous postoperatively
DRUGbupivacaine
continuous postoperatively
Sponsors
Asker & Baerum Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients at least 18 years of age * scheduled for elective total knee arthroplasty * ASA I-III * signed written informed consent
Exclusion criteria
* age \< 18 * ASA \> III * moderate or severe cardiac disease, bronchial asthma * allergy against ropivacaine, ketorolac or morphine * analgetic abuse * pregnancy or nursing women * severe psychiatric disease * moderate to severe dementia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain at Rest (VAS) | 48 hours postoperative | VAS (pain at rest) 0-100 mm. VAS 0 mm means no pain and VAS 100 mm means maximal pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use | 48 hours postoperative | Morphine used by patient controlled analgesia. Amount of used morphine during the first 48 hours after surgery were documented in the CRF by the pain nurses. |
| Time to Readiness for Discharge | up to 10 days postoperative | Each postoperative day, discharge readiness was assessed by an orthopaedic surgeon, a pain nurse, a ward nurse, and a physiotherapist according to the following criteria: no evidence for surgical complications, VAS pain at rest ≤30 mm which is controlled by oral analgesics, ability to eat and drink, ability to walk with elbow crutches, and ability to climb ≥8 stairs. |
Countries
Norway
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LIA IV (Local Infiltration Analgesia, Intravenous) Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine | 34 |
| LIA IA, (Local Infiltration Analgesia, Intra-articular) Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine | 34 |
| Epidural continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml | 34 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Total | LIA IV (Local Infiltration Analgesia, Intravenous) | LIA IA, (Local Infiltration Analgesia, Intra-articular) | Epidural |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 55 Participants | 18 Participants | 20 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants | 16 Participants | 14 Participants | 17 Participants |
| Age Continuous | 66.5 years STANDARD_DEVIATION 9.9 | 66.5 years STANDARD_DEVIATION 11 | 67.2 years STANDARD_DEVIATION 8.9 | 65.8 years STANDARD_DEVIATION 10.7 |
| Region of Enrollment Norway | 102 participants | 34 participants | 34 participants | 34 participants |
| Sex: Female, Male Female | 65 Participants | 21 Participants | 21 Participants | 23 Participants |
| Sex: Female, Male Male | 37 Participants | 13 Participants | 13 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 | 1 / 33 |
Outcome results
Primary
Pain at Rest (VAS)
VAS (pain at rest) 0-100 mm. VAS 0 mm means no pain and VAS 100 mm means maximal pain.
Time frame: 48 hours postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LIA IV (Local Infiltration Analgesia, Intravenous) | Pain at Rest (VAS) | 18 Units on a scale | Standard Deviation 15 |
| LIA IA, (Local Infiltration Analgesia, Intra-articular) | Pain at Rest (VAS) | 12 Units on a scale | Standard Deviation 13 |
| Epidural | Pain at Rest (VAS) | 30 Units on a scale | Standard Deviation 29 |
p-value: 0.001ANOVA
Secondary
Opioid Use
Morphine used by patient controlled analgesia. Amount of used morphine during the first 48 hours after surgery were documented in the CRF by the pain nurses.
Time frame: 48 hours postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LIA IV (Local Infiltration Analgesia, Intravenous) | Opioid Use | 77 mg | Standard Deviation 39 |
| LIA IA, (Local Infiltration Analgesia, Intra-articular) | Opioid Use | 49 mg | Standard Deviation 36 |
| Epidural | Opioid Use | 54 mg | Standard Deviation 43 |
p-value: 0.009ANOVA
Secondary
Time to Readiness for Discharge
Each postoperative day, discharge readiness was assessed by an orthopaedic surgeon, a pain nurse, a ward nurse, and a physiotherapist according to the following criteria: no evidence for surgical complications, VAS pain at rest ≤30 mm which is controlled by oral analgesics, ability to eat and drink, ability to walk with elbow crutches, and ability to climb ≥8 stairs.
Time frame: up to 10 days postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LIA IV (Local Infiltration Analgesia, Intravenous) | Time to Readiness for Discharge | 4 days | Standard Deviation 1.3 |
| LIA IA, (Local Infiltration Analgesia, Intra-articular) | Time to Readiness for Discharge | 3.5 days | Standard Deviation 0.7 |
| Epidural | Time to Readiness for Discharge | 5.5 days | Standard Deviation 1.6 |
p-value: <0.001ANOVA