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Tests treatment safety and results for Knee Stiffness After Total Knee Arthroplasty
Official title Flex Appeal: Evaluating the Efficacy of Anesthetic Techniques for Manipulation of Knees Under Anesthesia
ClinicalTrials.gov ID: NCT07348614
What this study is testing
What is Propofol?
Propofol is an investigational medicine, being studied as a potential treatment for knee stiffness after total knee arthroplasty.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine if changing the type of anesthesia improves the outcomes of manipulation and pain control after the procedure. The study will compare a spinal anesthesia with a general anesthesia, to see if there is a better outcome from either anesthesia type.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Inclusion:
- Patients ≥18 years presenting for a manipulation of knee joint under anesthesia.
- ASA Classification I - III.
- English speaking patients. Exclusion:
- ASA 4 or 5
See the full eligibility criteria
- Inclusion:
- Patients ≥18 years presenting for a manipulation of knee joint under anesthesia.
- ASA Classification I - III.
- English speaking patients. Exclusion:
- ASA 4 or 5
- Daily chronic opioid use (over 3 months of continuous opioid use).
- Inability to communicate pain scores or need for analgesia.
- Infection at the site of block placement
- Age under 18 years old or greater than 75 years old
- Pregnant women (as determined by point-of-care serum bHCG)
- Intolerance/allergy to local anesthetics
- Weight \<50 kg
- Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
- Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.
- BMI \>50 kg/m2.
- Allergy or contraindication to local anesthetics or any component of the multimodal analgesic regimen (NSAIDs and acetaminophen)
- Contraindication to spinal injection
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.