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Procedure
Nerve Block for Total Knee Replacement (CACB Trial)
N/A
Recruiting
Led By Naveed Siddiqui, MD
Research Sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively
Awards & highlights
CACB Trial Summary
This trial will assess if using a continuous nerve block during knee replacement surgery can reduce opioid use and improve patients' recovery and quality of life.
Who is the study for?
This trial is for adults over 21 years old who are having a knee replacement in a fast track program and have no drug or alcohol dependency. They must be generally healthy (ASA I-III), not dependent on opioids, without allergies to the study drugs, coagulopathy, low platelets, or issues that prevent catheter placement at the surgery site.Check my eligibility
What is being tested?
The study tests if continuous adductor canal block (CACB) with ropivacaine provides better pain control and recovery compared to a sham procedure (ShACB) using saline after knee replacement surgery. It measures opioid use, quality of recovery scores, pain levels, side effects from opioids, functional status post-surgery, complications related to the nerve block catheter and hospital readmissions.See study design
What are the potential side effects?
Potential side effects may include typical reactions to local anesthetics like ropivacaine such as nausea, vomiting, dizziness or numbness near the injection site. Complications could also arise from catheter placement like infection or bleeding.
CACB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
opioid consumption
Secondary outcome measures
Intensity of postoperative pain
Opioid related side effects
Quality of Recovery
CACB Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: CACBActive Control1 Intervention
continuous adductor canal block
Group II: Control groupPlacebo Group1 Intervention
sham continuous adductor canal block - ShACB
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Who is running the clinical trial?
Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor
127 Previous Clinical Trials
11,197 Total Patients Enrolled
Naveed Siddiqui, MDPrincipal InvestigatorAssociate Professor
6 Previous Clinical Trials
533 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand and agree to the use of a nerve block catheter.I have been taking the equivalent of 30mg morphine daily for the last 2 weeks.I am over 21 and fit for surgery according to ASA standards.I cannot have an epidural or catheter due to severe body structure issues or past surgery.I am having a knee replacement on one side in a fast track program.I was hospitalized due to complications or delays after surgery.
Research Study Groups:
This trial has the following groups:- Group 1: CACB
- Group 2: Control group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an ongoing enrollment period for this research?
"The clinicaltrials.gov platform has reported that this trial is not currently looking for participants; the original posting date was on September 1st 2023 and the most recent edit was made on July 26th, 2023. Nevertheless, there are 33 other studies actively seeking patients presently."
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Who else is applying?
What site did they apply to?
Mount Sinai Hospital, Toronto
What portion of applicants met pre-screening criteria?
Did not meet criteria
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