64 Participants Needed

Pain Management Techniques for Total Knee Replacement

JL
SM
PT
Overseen ByPa Thor, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Hospital for Special Surgery, New York
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to manage pain after knee replacement surgery. It compares two approaches—a real numbing treatment (adductor canal catheter) and a placebo (sham catheter)—to determine which reduces opioid use in the days following surgery. Participants must communicate with their doctor using a mobile app during this period. The trial suits those scheduled for knee replacement due to osteoarthritis and who can follow the study's protocol. As an unphased trial, it offers participants the opportunity to contribute to innovative pain management solutions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are using gabapentin, pregabalin, or opioids regularly, you may not be eligible to participate.

What prior data suggests that these pain management techniques are safe for total knee replacement patients?

Research has shown that an adductor canal catheter (ACC) is generally safe for managing pain after total knee replacement surgery. One study found that this method effectively reduces pain without causing serious side effects. Another study demonstrated that using a continuous catheter poses no greater risk than a single injection. Important safety concerns include falls, infections, nerve injuries, and muscle weakness, but these issues are rare and usually manageable. Overall, the ACC is well-tolerated and provides effective pain relief.12345

Why are researchers excited about this trial?

Researchers are excited about these pain management techniques for total knee replacement because they potentially offer a more targeted approach to pain relief. Unlike traditional methods that often rely on systemic painkillers like opioids, the adductor canal catheter delivers numbing medication directly to the operative leg, which may reduce the need for oral pain medication and its associated side effects. Additionally, the use of the Diagnotes application enables real-time communication with pain doctors, allowing for personalized pain management adjustments and potentially improving patient outcomes. This combination of local anesthesia and digital health monitoring represents a promising innovation in post-surgical care.

What evidence suggests that these pain management techniques could be effective for total knee replacement?

This trial will compare the effectiveness of an Adductor Canal Catheter (ACC) with a Sham Adductor Canal Catheter for pain management after knee replacement surgery. Research has shown that using an ACC can reduce pain following knee replacement surgery. Studies have found that continuous pain relief with an ACC provides better pain control than some other methods. However, some research suggests the additional benefit might be small. Adductor canal blocks, whether using a catheter or not, effectively manage pain after knee surgeries. Overall, ACCs appear to be a promising option for reducing pain and may help lower the need for opioids after surgery.56789

Who Is on the Research Team?

SM

Stavros Memtsoudis, MD/PhD

Principal Investigator

Hospital for Special Surgery, New York

JP

Jashvant Poeran, MD/PhD

Principal Investigator

Hospital for Special Surgery, New York

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am scheduled for a knee replacement surgery with a participating surgeon due to osteoarthritis.
I will be receiving regional anesthesia.
Patients of participating surgeons: Drs. Mayman, Jerabek, Westrich, Su, Della Valle, Alexiades
See 3 more

Exclusion Criteria

I have diabetes.
I have been taking gabapentin or pregabalin regularly for more than 3 months.
I will be undergoing surgery with general anesthesia.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Immediate Post-operative Care

Participants undergo total knee arthroplasty and receive either an adductor canal catheter or a sham catheter for 50 hours post-surgery.

1 week
Inpatient stay up to 7 days

Transitional Pain Service (TeleTPS)

Participants use the Diagnotes app to communicate with the pain doctor while the catheter is in place, and manage pain post-discharge.

Up to 50 hours post-surgery

Follow-up

Participants are monitored for opioid consumption, chronic pain, and other outcomes up to 6 months post-operation.

6 months
Regular follow-ups at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Adductor Canal Catheter
  • Sham Adductor Canal Catheter
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Adductor Canal Catheter (ACC) - InterventionalExperimental Treatment1 Intervention
Group II: Adductor Canal Block (ACB) - ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials
257
Recruited
61,800+

Published Research Related to This Trial

The adductor canal block using ropivacaine significantly reduced pain during knee flexion at 4 hours post-surgery compared to placebo, with a mean difference of 19 mm in pain scores (P = 0.04).
Despite the reduction in pain during flexion, there were no significant differences in pain at rest, morphine consumption, or morphine-related side effects between the ropivacaine and placebo groups, indicating that while the block may help with movement pain, it does not affect overall pain management or opioid use.
Adductor canal block for postoperative pain treatment after revision knee arthroplasty: a blinded, randomized, placebo-controlled study.Jæger, P., Koscielniak-Nielsen, ZJ., Schrøder, HM., et al.[2019]

Citations

The effects of continuous catheter adductor canal block for ...Our meta-analysis appears to demonstrate that continuous administration of analgesia through an adductor canal catheter provides greater pain reduction in ...
Is There Benefit in Using an Adductor Canal Catheter in ...We found that not using the ACC was noninferior to using the ACC, suggesting that the incremental benefit of the ACC is small and likely of insufficient ...
Epidural Catheter With or Without Adductor Canal Nerve ...Adductor canal nerve blocks have been shown in the literature to be an effective method for postoperative pain control in total knee replacement surgery. One of ...
Outpatient continuous adductor canal block (CACB) for ...Single-injection adductor canal blocks (SACB) provide effective but short-lived pain relief after total knee arthroplasty, with limited ...
Adductor Canal Block for Knee Surgeries: An Emerging ...ACB is an emerging technique for postoperative analgesia following knee surgery and is as effective as FNB in postoperative pain control.
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40177059/
Adductor canal block in total knee arthroplasty: a scoping ...Adductor canal block is a safe and potentially effective peripheral nerve block for reducing postoperative pain after total knee arthroplasty while preserving ...
a systemic review and meta-analysis of randomized trialsConclusions Our results suggest that continuous catheter-based ACB does not enhance or prolong the analgesic benefits when compared with single-shot ACB for TKA ...
Adductor canal block in total knee arthroplasty: a scoping ...Important safety outcomes were falls, infection, nerve injury, and quadriceps weakness. Methods. We used the Preferred Reporting Items for Systematic Reviews ...
Adductor Canal Nerve Block Following Total Knee ...The purpose of this study is that an adductor canal nerve block (putting numbing medicine near the nerve) has been shown to produce excellent pain relief with ...
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