Postoperative Pain
Conditions
Keywords
Total Knee Arthroplasty
Brief summary
The purpose of this study is to determine wether ketorolac is effective in the treatment of postoperative pain after total knee arthroplasty
Interventions
DRUGKetorolac
30 mg (1 ml) infiltration combined with Intraarticular bolus injection of 120 mg (4 ml) ketorolac
DRUGSaline
1 ml infiltration 4 ml intraarticular bolus injection of placebo
Sponsors
University of Aarhus
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
* Total knee arthroplasty * Age \> 18 * Tolerance for study drugs * Written informed consent
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Consumption | 48 hours after surgery | Consumption of intravenous (i.v.) patient-controlled analgesia (PCA) morphine during the first forty-eight hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First i.v. Patient Controlled Analgesia (PCA) Morphine Request | within 48 hours after surgery | — |
| Pain Intensity Scores During Walking | 6-24 hours postoperatively | Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible) |
| Home Readiness | time to fulfilment of discharge criteria | Ability to meet discharge criteria (home readiness) |
| Length of Hospital Stay | From the day of surgery until discharge | — |
| Pain Intensity During Daily Activity | 16 weeks after surgery | Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible) |
Countries
Denmark
Participant flow
Recruitment details
A total of 361 patients were assessed for eligibility from May 2009 through March 2011; 62 patients participated in another study, 54 patients declined to participate, and 185 patients were excluded based on the exclusion criteria. Sixty patients (30 in each group)were enrolled, and data for the primary endpoint were registered in all patients
Participants by arm
| Arm | Count |
|---|---|
| Control Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline | 30 |
| Ketorolac Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Ketorolac | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 22 Participants | 19 Participants | 41 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 11 Participants | 19 Participants |
| Age, Continuous | 70 years | 71 years | 71 years |
| Region of Enrollment Denmark | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 13 Participants | 19 Participants | 32 Participants |
| Sex: Female, Male Male | 17 Participants | 11 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 2 / 30 |
Outcome results
Primary
Morphine Consumption
Consumption of intravenous (i.v.) patient-controlled analgesia (PCA) morphine during the first forty-eight hours after surgery
Time frame: 48 hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Morphine Consumption | 48.75 mg |
| Ketorolac | Morphine Consumption | 10 mg |
Secondary
Home Readiness
Ability to meet discharge criteria (home readiness)
Time frame: time to fulfilment of discharge criteria
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Home Readiness | 3 days |
| Ketorolac | Home Readiness | 2 days |
Secondary
Length of Hospital Stay
Time frame: From the day of surgery until discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Length of Hospital Stay | 3 days |
| Ketorolac | Length of Hospital Stay | 3 days |
Secondary
Pain Intensity During Daily Activity
Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)
Time frame: 16 weeks after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Pain Intensity During Daily Activity | 4 mm |
| Ketorolac | Pain Intensity During Daily Activity | 3 mm |
Secondary
Pain Intensity Scores During Walking
Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)
Time frame: 6-24 hours postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Pain Intensity Scores During Walking | 64 mm |
| Ketorolac | Pain Intensity Scores During Walking | 29 mm |
Secondary
Time to First i.v. Patient Controlled Analgesia (PCA) Morphine Request
Time frame: within 48 hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Time to First i.v. Patient Controlled Analgesia (PCA) Morphine Request | 223 min |
| Ketorolac | Time to First i.v. Patient Controlled Analgesia (PCA) Morphine Request | 490 min |