What side effects are associated with this type of intervention?

Common treatments for chronic pain, such as continuous nerve blocks and epidural steroid injections, can have several side effects. Continuous nerve blocks, like the adductor canal catheter, may cause increased pain, transient lower limb numbness, and paraesthesias. Epidural steroid injections can lead to short-term pain relief but may also result in transient lower limb numbness, superficial burns, and increased pain. These treatments are generally safe but can have adverse effects that should be monitored by healthcare providers.

What prior FDA approvals exist?

The FDA has approved various treatments for chronic pain, including medications such as opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), and certain antidepressants and anticonvulsants. For interventional approaches, the FDA has approved treatments like epidural steroid injections, nerve blocks, and spinal cord stimulation. While specific FDA approvals for continuous local anesthetic delivery to the adductor canal are not detailed, similar interventional techniques like continuous nerve blocks and local anesthetic infusions are commonly used in clinical practice for managing chronic pain.

What other types of research exist?

Promising novel alternatives to Adductor Canal Catheter (ACC) for chronic pain management include: 1) Genicular nerve block, which involves the ablation of specific knee nerves using radiofrequency or chemicals and has shown effectiveness in pain reduction. 2) Spinal cord stimulation, which involves the implantation of a device that sends electrical impulses to the spinal cord to reduce pain. 3) Intravesical botulinum toxin A injections, which have shown efficacy in reducing bladder pain and may be applicable to other chronic pain conditions. 4) Multimodal analgesia, which combines various non-opioid medications and techniques to manage pain effectively.

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Procedure

Pain Management Techniques for Total Knee Replacement

N/A

Recruiting

Led By Stavros Memtsoudis, MD/PhD

Research Sponsored by Hospital for Special Surgery, New York

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 to 75 years

Patients with osteoarthritis scheduled for a primary total knee arthroplasty with a participating surgeon

Must not have

Diabetes

Patients with severe valgus deformity or flexion contracture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months & 6 months

Summary

This trial tests if delivering numbing medicine through a small tube can reduce pain and opioid use in knee replacement patients. It aims to see if this method helps manage pain better than other methods.

Who is the study for?

This trial is for adults aged 18-75 with osteoarthritis scheduled for knee replacement surgery at certain surgeons, living within an hour of the hospital, owning a smartphone, and able to follow instructions in English. Excluded are those with general anesthesia, drug allergies, BMI >40, diabetes, severe joint deformity or contracture, chronic opioid or gabapentin use.

What is being tested?

The study tests if there's a difference in opioid use after surgery between patients getting an adductor canal catheter (ACC) versus a sham catheter. It uses the Diagnotes app for communication and checks pain levels up to 6 months post-surgery.

What are the potential side effects?

Potential side effects may include discomfort at the catheter site, possible infection risk from the catheter placement and side effects related to opioids such as nausea, constipation or drowsiness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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I am scheduled for a knee replacement surgery with a participating surgeon due to osteoarthritis.

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I will be receiving regional anesthesia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have diabetes.

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I have a severe knee bend or cannot fully straighten my knee.

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I will be undergoing surgery with general anesthesia.

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My health status is moderately to severely impaired.

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I cannot manage a catheter at home or refuse to have one.

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I am younger than 18 or older than 65.

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I have liver or kidney problems.

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I am planning to stay at a rehabilitation facility.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months & 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months & 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months & 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Opioid consumption at 24-48 hours

Secondary study objectives

Blinding Assessment

Block complications

Block resolution

+25 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Adductor Canal Catheter (ACC) - InterventionalExperimental Treatment1 Intervention

Patients will received the an adductor canal catheter that continuously infuses numbing medication to their operative leg for 50 hours post-surgery. Patients will also communicate with their pain doctor via the Diagnotes application while the catheter is in place.

Group II: Adductor Canal Block (ACB) - ControlPlacebo Group1 Intervention

Patients will received the a sham adductor canal catheter that is attached to their operative leg for 50 hours post-surgery. Patients will also communicate with their pain doctor via the Diagnotes application while the catheter is in place.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Interventional therapies for chronic pain, such as the adductor canal catheter, work by delivering local anesthetics directly to specific nerves, thereby blocking pain signals at their source. This method is particularly effective for focal pain and can provide significant relief with fewer systemic side effects compared to oral medications. Other common treatments include epidural steroid injections, which reduce inflammation around spinal nerves, and spinal cord stimulation, which disrupts pain signal transmission to the brain. These targeted approaches are crucial for chronic pain patients as they offer tailored pain relief, potentially improving function and quality of life while minimizing the risk of long-term opioid use and its associated complications.

Central Nervous System Targets: Supraspinal Mechanisms of Analgesia.Pathophysiologic Approach to Pain Therapy for Complex Pain Entities: A Narrative Review.Hydrotherapy, balneotherapy, and spa treatment in pain management.