Nerve Block for Total Knee Replacement

(CACB Trial)

Overseen By David Backstein, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Must not be taking: Chronic opioids

Disqualifiers: Alcohol, Drug dependency, Coagulopathy, others

Compensation: Varies

Number of Visits: 26

Duration: 48 hours

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Total knee arthroplasty (TKA) is a frequent performed surgery. Many institutions are implementing fast track programs for this surgery and adequate pain management is an important feature. Analgesic duration of single shot nerve blocks is limited to no more than 24h. Conversely, the use of continuous nerve block (CNB) through a perineural catheter and infusion of local anesthetic may increase duration of analgesia and provide better outcomes. The purpose of this study is to evaluate effectiveness and safety of using CNB in patients undergoing ambulatory TKA, and its effects on patients' quality of recovery. Investigators hypothesize that continuous adductor canal block would lead to decrease in opioid consumption in patients undergoing fast track TKA. Significance There are no published prospective randomized controlled trials to assess patient's reported quality of recovery after receiving CACB in same day primary knee arthroplasties. As this is a frequent type of surgery and has the prediction to increase its incidence for the next years, there is significant importance in investigations about interventions which may improve its recovery in a fast track regime. A postoperative analgesic technique that offers better pain control, has less adverse effects, reduces the opioid analgesia requirement and is safe to be used in a fast track setting may have additional impact on decreasing health care cost and may lead to an enhanced recovery and better quality of life. Objectives To evaluate effectiveness and safety of using CACB in patients undergoing ambulatory TKA, in comparison to SACB. Primary objective is opioid consumption (in oral morphine equivalent doses) Secondary objectives are to evaluate postoperative QoR-15 scores (10), pain scores, opioid-induced adverse effects (measured via validated opioid symptom distress scale), postoperative functional status, complications relating to the perineural catheter and readmissions.

Research Team

Naveed Siddiqui, MD

Principal Investigator

Associate Professor

Eligibility Criteria

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.

Inclusion Criteria

I understand and agree to the use of a nerve block catheter.

No alcohol or drug dependency

I am over 21 and fit for surgery according to ASA standards.

Exclusion Criteria

Allergy to the study medications

I have been taking the equivalent of 30mg morphine daily for the last 2 weeks.

Coagulopathy and platelet count less than 105/μL

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Preoperative Preparation

Patients undergo pre-anesthesia consultation and receive study information and consent forms

A few days before surgery

1 visit (in-person)

Treatment

Patients receive either continuous adductor canal block or sham block during and after surgery

48 hours

In-hospital stay and discharge

Postoperative Monitoring

Data collection on opioid consumption, pain intensity, and quality of recovery

90 days

Data collection at 24, 48, 72 hours, 7, 30, and 90 days postoperatively

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

Treatment Details

Interventions

• Continuous Adductor Canal Block

Trial Overview 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.

Participant Groups

Group I: CACB Active Control 1 Intervention

continuous adductor canal block

Group II: Control group Placebo Group 1 Intervention

sham continuous adductor canal block - ShACB

Who Is Running the Clinical Trial?

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Lead Sponsor

Trials

132

Recruited

11,400+