Osteoarthritis, Knee
Conditions
Brief summary
The purpose of this research is to study how well the adductor canal pain catheters works after a total knee arthroplasty or replacement of the knee joint. The catheter works by using either an intermittent bolus injection to provide a large dose of medication or continuous infusion of pain medicine, ropivacaine 0.2%, compared to a single-shot adductor canal block.
Interventions
DRUGRopivacaine Continuous Infusion
0.2% continuous infusion 6mL/hr
DRUGRopivacaine Intermittent Bolus
0.2% intermittent bolus infusion 8mL every 2 hours
DRUGPlacebo
Saline filled catheter
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
This will be a double-blinded study. Computer randomization will be used for patient grouping and the research pharmacy will dispense the medication to the anesthesia team, who will set the adductor catheter dosing based upon randomization. The surgical team and patient will remain blinded to the medication and dosing regimen.
Intervention model description
A Three-Arm, Double-Blinded, Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 and ≤ 90 years. * Willing to participate in the study and competent to provide informed consent. * Willing to comply with protocol procedures. * Has an underlying diagnosis of osteoarthritis indicated for a total knee arthroplasty.
Exclusion criteria
* The patient must not have taken any narcotic medications (schedule II) during the 3 months leading up to the surgery. * The patient must not be allergic or intolerant to a medication used in the multimodal pain pathway. * Revision knee arthroplasty. * Uncontrolled diabetes with A1C \> 8.0%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain Levels | 14 days post-operatively | Patient self-reported pain intensity score measured on the Visual Analogue Scale (VAS) rated from 0-10, where 0 was no pain and 10 was the worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Medication Administered | 60 days, or until discontinuation of narcotic medication (whichever is later) | Amount of medication administered via the patient-controlled function on the adductor catheter |
| Duration of Narcotic Used | 60 days, or until discontinuation of narcotic medication (whichever is later) | Number of days that narcotic use was required. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Shot Adductor Canal Subjects had a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with saline.
Placebo: Saline filled catheter | 21 |
| Ropivacaine Continuous Subjects had a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with 0.2% ropivacaine dispersed in a continuous infusion.
Ropivacaine Continuous Infusion: 0.2% continuous infusion 6mL/hr | 20 |
| Ropivacaine Intermittent Bolus Subjects had a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with 0.2% ropivacaine dispersed in pulsed intermittent bolus.
Ropivacaine Intermittent Bolus: 0.2% intermittent bolus infusion 8mL every 2 hours | 19 |
| Total | 60 |
Baseline characteristics
| Characteristic | Single Shot Adductor Canal | Total | Ropivacaine Intermittent Bolus | Ropivacaine Continuous |
|---|---|---|---|---|
| Age, Continuous | 75 years | 72 years | 70 years | 71 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 18 Participants | 55 Participants | 18 Participants | 19 Participants |
| Region of Enrollment United States | 21 participants | 60 participants | 19 participants | 20 participants |
| Sex: Female, Male Female | 15 Participants | 34 Participants | 12 Participants | 7 Participants |
| Sex: Female, Male Male | 6 Participants | 26 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 0 / 21 | 3 / 20 | 2 / 19 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 | 0 / 19 |
Outcome results
Primary
Post-operative Pain Levels
Patient self-reported pain intensity score measured on the Visual Analogue Scale (VAS) rated from 0-10, where 0 was no pain and 10 was the worst pain imaginable.
Time frame: 14 days post-operatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Shot Adductor Canal | Post-operative Pain Levels | 5.1 score on a scale |
| Ropivacaine Continuous | Post-operative Pain Levels | 5.1 score on a scale |
| Ropivacaine Intermittent Bolus | Post-operative Pain Levels | 6.1 score on a scale |
Secondary
Amount of Medication Administered
Amount of medication administered via the patient-controlled function on the adductor catheter
Time frame: 60 days, or until discontinuation of narcotic medication (whichever is later)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Shot Adductor Canal | Amount of Medication Administered | 138 mL |
| Ropivacaine Continuous | Amount of Medication Administered | 111 mL |
| Ropivacaine Intermittent Bolus | Amount of Medication Administered | 144 mL |
Secondary
Duration of Narcotic Used
Number of days that narcotic use was required.
Time frame: 60 days, or until discontinuation of narcotic medication (whichever is later)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Shot Adductor Canal | Duration of Narcotic Used | 21 days |
| Ropivacaine Continuous | Duration of Narcotic Used | 14 days |
| Ropivacaine Intermittent Bolus | Duration of Narcotic Used | 14 days |