Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine intermittent bolus | Experimental | Subjects will have a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with 0.2% ropivacaine dispersed in pulsed intermittent bolus. |
|
| Ropivacaine continuous | Experimental | Subjects will have a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with 0.2% ropivacaine dispersed in a continuous infusion. |
|
| Single shot adductor canal | Placebo Comparator | Subjects will have a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine Continuous Infusion | Drug | 0.2% continuous infusion 6mL/hr |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Medication Administered | Amount of medication administered via the patient-controlled function on the adductor catheter | 60 days, or until discontinuation of narcotic medication (whichever is later) |
| Duration of Narcotic Used |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Benjamin Wilke, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Ropivacaine Continuous |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Full Range | score on a scale | 14 days post-operatively |
|
Adverse events were collected from baseline to end of study, approximately, 60 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter removed early | Surgical and medical procedures | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin K. Wilke, M.D. | Mayo Clinic | 904-953-2405 | Wilke.Benjamin@mayo.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 13, 2022 | Dec 8, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
A Three-Arm, Double-Blinded, Randomized Controlled Trial
Not provided
Not provided
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.
| Ropivacaine Intermittent Bolus |
| Drug |
0.2% intermittent bolus infusion 8mL every 2 hours |
|
| Placebo | Drug | Saline filled catheter |
|
Number of days that narcotic use was required.
| 60 days, or until discontinuation of narcotic medication (whichever is later) |
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
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 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 |
|
|
| Secondary | Amount of Medication Administered | Amount of medication administered via the patient-controlled function on the adductor catheter | Posted | Median | Full Range | mL | 60 days, or until discontinuation of narcotic medication (whichever is later) |
|
|
|
| Secondary | Duration of Narcotic Used | Number of days that narcotic use was required. | Posted | Median | Full Range | days | 60 days, or until discontinuation of narcotic medication (whichever is later) |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | 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 | 0 | 20 | 0 | 20 | 3 | 20 |
| EG002 | 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 | 0 | 19 | 0 | 19 | 2 | 19 |
| Catheter placed incorrectly | Surgical and medical procedures | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Knew swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Knee bruising | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D012216 |
| Rheumatic Diseases |