A Study to Compare the Effectiveness of Adductor Canal Pain Catheters Following Total Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT05053087|
Recruitment Status : Recruiting
First Posted : September 22, 2021
Last Update Posted : May 2, 2022
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Drug: Ropivacaine Continuous Infusion Drug: Ropivacaine Intermittent Bolus Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A Three-Arm, Double-Blinded, Randomized Controlled Trial|
|Masking:||Double (Participant, 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.|
|Official Title:||A Three-Arm, Double-Blinded, Randomized Controlled Trial Comparing the Efficacy of Adductor Canal Pain Catheters Following Total Knee Arthroplasty|
|Actual Study Start Date :||April 13, 2022|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||June 2023|
Experimental: Ropivacaine group with bolus infusions
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.
Drug: Ropivacaine Intermittent Bolus
0.2% intermittent bolus infusion 8mL every 2 hours
Experimental: Ropivacaine group with continuous infusions
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.
Drug: Ropivacaine Continuous Infusion
0.2% continuous infusion 6mL/hr
Placebo Comparator: Single shot adductor canal block group
Subjects will have a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with saline.
Saline filled catheter
- Post-operative pain levels [ Time Frame: 14 days post-operatively ]Measured using a visual analogue scale (VAS) where subject places a mark on a horizontal line to rate the intensity of their pain at the time between no pain and worst pain imaginable.
- Amount of medication administered [ Time Frame: 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 [ Time Frame: 60 days, or until discontinuation of narcotic medication (whichever is later) ]Number of days narcotic use is required
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05053087
|Contact: Angelica Klosowski||904-953-4529||Klosowski.Angelica@mayo.edu|
|Contact: Arjana Haliliovic||(904) firstname.lastname@example.org|
|United States, Florida|
|Mayo Clinic in Florida||Recruiting|
|Jacksonville, Florida, United States, 32224|
|Principal Investigator:||Benjamin Wilke, MD||Mayo Clinic|