128 Participants NeededMy employer runs this trial

Anesthetic Techniques for Arthrofibrosis

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if different types of anesthesia can enhance recovery and pain control for individuals undergoing a knee procedure called manipulation under anesthesia. It compares spinal anesthesia, where medicine is injected near the spine, with general anesthesia, which induces sleep throughout the body. Suitable candidates for this trial include those needing knee manipulation, who have not used long-term opioids, and can communicate their pain levels. As a Phase 4 trial, this research seeks to understand how an already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using daily chronic opioids, you would not be eligible to participate.

What is the safety track record for these anesthetic techniques?

Research shows that spinal anesthesia is generally safe, though it carries some risks. A small number of patients may experience headaches or low blood pressure after receiving it. Specifically, about 0.5% to 1.5% of patients might develop a headache, while 71% could experience low blood pressure. These side effects are usually manageable.

General anesthesia is also widely used and considered safe for many surgeries, though it can cause side effects like nausea and a sore throat. Both types of anesthesia have been safely used in many patients, each with its own risks and benefits. Discussing options with a healthcare provider is important to determine the best choice for individual needs and situations.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores two different anesthetic techniques for treating arthrofibrosis during manipulation under anesthesia (MUA). Unlike the standard approach of general anesthesia, which affects the entire body and can involve longer recovery times, spinal anesthesia targets nerves in the lower spine, potentially offering quicker recovery and fewer systemic side effects. By comparing these methods, the trial aims to determine if spinal anesthesia can provide a safer, more efficient option for patients undergoing MUA, potentially transforming the way arthrofibrosis is managed.

What evidence suggests that this trial's anesthetic techniques could be effective for arthrofibrosis?

This trial will compare spinal anesthesia and general anesthesia for patients undergoing manipulation under anesthesia (MUA) for arthrofibrosis. Research has shown that spinal anesthesia, which participants in one arm of this trial will receive, can help manage pain and improve movement after certain surgeries. Studies have found that it often provides better immediate pain relief and helps maintain movement in patients post-surgery. Spinal anesthesia tends to have fewer complications and can improve movement more effectively than other methods. In contrast, general anesthesia, which participants in another arm of this trial will receive, is commonly used and works well for many surgeries, but it might not be as effective in preserving movement and reducing pain afterward. Both types of anesthesia are widely used, but spinal anesthesia may offer specific advantages, such as in treating joint stiffness.678910

Who Is on the Research Team?

EH

Emily Hall

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 75 who need a knee manipulation under anesthesia due to stiff knees (arthrofibrosis). Participants must be able to communicate in English, not use opioids daily, and have no serious health issues or allergies to anesthetics.

Inclusion Criteria

I am unable to communicate my pain or need for pain medication.
6. Pregnant women (as determined by point-of-care serum bHCG)
7. Intolerance/allergy to local anesthetics
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo manipulation under anesthesia with either spinal or general anesthesia

1 day
1 visit (in-person)

Follow-up

Participants are monitored for pain and outcomes post-procedure

1 week
3 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Chloroprocaine
  • General Anesthesia
  • Propofol
  • Spinal Anesthesia

Trial Overview

The study compares two types of anesthesia—spinal (using chloroprocaine) versus general (using propofol)—to see which works better for pain control and recovery after knee manipulation. Patients are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Spinal AnesthesiaExperimental Treatment2 Interventions
Group II: General AnesthesiaActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

Citations

Manipulation Under Anesthesia and Lysis of Adhesions ... - PMC

To systematically review the literature and provide a detailed summary of the current treatments and outcomes for arthrofibrosis following knee arthroscopy ...

Multimodal conservative management of arthrofibrosis after ...

Overall, knee ROM outcomes were under anesthesia (109° ± 11). Seven out of ten patients achieved functional ROM (≥ 110°) and avoided ...

Manipulation under anaesthesia versus lysis of adhesions for ...

Recent studies show similar outcomes between lysis of adhesions (LOA) and manipulation under anaesthesia (MUA) in patients with arthrofibrosis within 3 to 6 ...

Comparative Effects of Spinal Anesthesia and Combined ...

Adding ACB and SNB to spinal anesthesia improved immediate postoperative pain relief and preserved range of motion in patients undergoing ACL reconstruction.

Conservative treatment of knee arthrofibrosis according to ...

In contrast, the conservative AF program was effective: In most patients, clear gains of 10–30° for flexion and 5° for extension were already ...

Multimodal conservative management of arthrofibrosis after ...

Seven out of ten patients achieved functional ROM (≥ 110°) and avoided manipulation under anesthesia with the multimodal physical therapy ...

Manipulation under anaesthesia versus lysis of adhesions for ...

Background: Recent studies show similar outcomes between lysis of adhesions (LOA) and manipulation under anaesthesia (MUA) in patients with arthrofibrosis ...

Manipulation Under Anesthesia and Lysis of Adhesions ...

29 (69.0%) were reported data for adults and 13 (31.0%) reported data for pediatric patients. Outcome data for each procedure were reported in the following ...

A Comparative Retrospective Analysis of Anesthetic ...

It represents a safe and effective alternative to GA in older spine surgery patients. Key Words: Geriatric patients, Spinal anesthesia, General ...

Effectiveness and safety of exclusive spinal anesthesia ...

SA is considered to be safe, though not risk-free.9 some disadvantages have been described, such as puncture site pain, post-puncture headache, urinary ...