Osteoarthritis, Knee
Conditions
Brief summary
This study will evaluate the use of a local injection around the knee (periarticular) during total knee replacement (TKR) surgery to see if it reduces postoperative pain levels. The injection is a combination of various medications which are thought to reduce pain levels. Approximately 128 patients will participate in this study, half of the patients will receive this injection during surgery and the other half will receive a saline (salt water) injection. Pain scores after the surgery will be compared between the two groups. All patients will also receive a long-acting (24 hours) morphine injection during surgery. The hypothesis is that those participants receiving intrathecal Duramorph and local periarticular injections will have improved pain scores and reduced narcotic use when compared with intrathecal Duramorph alone at 48 hours postoperatively.
Detailed description
Data Collection: Data will be collected from the patient's medical record after discharge Variables include: * Age * Sex * BMI * UPAT score (Universal Pain Assessment Tool)- this is assessed hourly postoperatively by nursing staff on Orthopedics Unit * Patient's assessment of acceptability of pain * UPAT score as assessed by physical therapy pre and post therapy sessions * Duramorph dose * Time patient arrived on the Orthopedic Unit * Length of ambulation during physical therapy sessions * Amount of supplementary opioids (measured in morphine equivalents) * Use of anti-emetics * Any complications of surgery including venous thromboembolic event, cardiac event, bleeding event * Length of hospital stay The pharmacist will randomize patients to either study arm, prepare the injection and maintain dispensing records.
Interventions
DRUGRopivacaine
Ropivacaine (5mg/ml)-50ml
DRUGKetorolac
ketorolac (30mg/ml)- 1 ml
DRUGClonidine
clonidine (0.1mg/ml)- 0.8ml
DRUGEpinephrine
epinephrine (1mg/ml)-1ml
DRUG0.9% sodium chloride
Sodium chloride 0.9%- 47.7 ml
Sponsors
Virginia Commonwealth University
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
Yes
Inclusion criteria
* Age 18 or older * Written informed consent
Exclusion criteria
* Pregnant women * Creatinine clearance less than 60 ml/min * BMI greater than 40 * Currently use greater than 80mg morphine-equivalents daily (pre-operatively) * Receive a unicondylar knee replacement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Universal Pain Assessment Tool (UPAT) | 3 days after surgery | Patient's pain scores will be measured with the UPAT scale which ranges from 0 (no pain) to 10 (severe pain) This is measured hourly while the patient is awake after the surgery. |
| Narcotic Use During Hospitalization | 0-24 hours post surgery period, 24 - 48 hours post surgery period, and Full 48 hours post surgery period | The amount of narcotic pain medication needed for patient to be comfortable. This is measured in morphine equivalents since there are many pain medications other than morphine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ambulation During Physical Therapy | 48 hours after surgery | The length (in feet) patient is able to ambulate during physical therapy |
| Patient's Subjective Rating of Pain | 3 days after surgery | Patients are asked if their pain is acceptable (yes/no) |
| UPAT Score Before and After Physical Therapy | 3 days after surgery | Pain in score change after physical therapy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ROP/KET/CLON/EPI/SAL Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml
Ropivacaine: Ropivacaine (5mg/ml)-50ml
Ketorolac: ketorolac (30mg/ml)- 1 ml
Clonidine: clonidine (0.1mg/ml)- 0.8ml
Epinephrine: epinephrine (1mg/ml)-1ml
0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml | 34 |
| Placebo 0.9% Sodium Chloride- 100ml
0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml | 30 |
| Total | 64 |
Baseline characteristics
| Characteristic | Placebo | Total | ROP/KET/CLON/EPI/SAL |
|---|---|---|---|
| Age, Continuous | 64.1 years STANDARD_DEVIATION 9.4 | 64.6 years STANDARD_DEVIATION 8.6 | 65.0 years STANDARD_DEVIATION 8.1 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 30 participants | 64 participants | 34 participants |
| Sex: Female, Male Female | 16 Participants | 31 Participants | 15 Participants |
| Sex: Female, Male Male | 14 Participants | 33 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 30 |
| other Total, other adverse events | 0 / 34 | 0 / 30 |
| serious Total, serious adverse events | 0 / 34 | 0 / 30 |
Outcome results
Primary
Narcotic Use During Hospitalization
The amount of narcotic pain medication needed for patient to be comfortable. This is measured in morphine equivalents since there are many pain medications other than morphine.
Time frame: 0-24 hours post surgery period, 24 - 48 hours post surgery period, and Full 48 hours post surgery period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ROP/KET/CLON/EPI/SAL | Narcotic Use During Hospitalization | 24 to 48 hour post surgery period | 66.5 mg morphine equivalents | Standard Deviation 51.3 |
| ROP/KET/CLON/EPI/SAL | Narcotic Use During Hospitalization | Full 48 hour post surgery period | 125.6 mg morphine equivalents | Standard Deviation 80.7 |
| ROP/KET/CLON/EPI/SAL | Narcotic Use During Hospitalization | 0 to 24 hour post surgery period | 58.9 mg morphine equivalents | Standard Deviation 41.2 |
| Placebo | Narcotic Use During Hospitalization | 24 to 48 hour post surgery period | 72.8 mg morphine equivalents | Standard Deviation 61.7 |
| Placebo | Narcotic Use During Hospitalization | Full 48 hour post surgery period | 145.7 mg morphine equivalents | Standard Deviation 99.2 |
| Placebo | Narcotic Use During Hospitalization | 0 to 24 hour post surgery period | 72.3 mg morphine equivalents | Standard Deviation 49.4 |
Primary
Universal Pain Assessment Tool (UPAT)
Patient's pain scores will be measured with the UPAT scale which ranges from 0 (no pain) to 10 (severe pain) This is measured hourly while the patient is awake after the surgery.
Time frame: 3 days after surgery
Population: Protocol was amended early in the study to omit this outcome due to apparent data irregularities - no data was collected and no outcomes can be reported
Secondary
Ambulation During Physical Therapy
The length (in feet) patient is able to ambulate during physical therapy
Time frame: 48 hours after surgery
Population: Protocol was amended early in the study to omit this outcome due to apparent data irregularities - no data was collected and no outcomes can be reported
Secondary
Patient's Subjective Rating of Pain
Patients are asked if their pain is acceptable (yes/no)
Time frame: 3 days after surgery
Population: Protocol was amended early in the study to omit this outcome due to apparent data irregularities - no data was collected and no outcomes can be reported
Secondary
UPAT Score Before and After Physical Therapy
Pain in score change after physical therapy
Time frame: 3 days after surgery
Population: Protocol was amended early in the study to omit this outcome due to apparent data irregularities - no data was collected and no outcomes can be reported