Flex Appeal: Evaluating the Efficacy of Anesthetic Techniques for Manipulation of Knees Under Anesthesia
Recruiting
Phase 4Interventional Study
Knee Stiffness After Total Knee Arthroplasty
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
128 (estimated)
Sponsor
Duke University · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion:
1. Patients ≥18 years presenting for a manipulation of knee joint under anesthesia.
2. ASA Classification I - III.
3. English speaking patients.
Exclusion:
1. ASA 4 or 5
2. Daily chronic opioid use (over 3 months of continuous opioid use).
3. Inability to communicate pain scores or nee…
Inclusion:
1. Patients ≥18 years presenting for a manipulation of knee joint under anesthesia.
2. ASA Classification I - III.
3. English speaking patients.
Exclusion:
1. ASA 4 or 5
2. Daily chronic opioid use (over 3 months of continuous opioid use).
3. Inability to communicate pain scores or need for analgesia.
4. Infection at the site of block placement
5. Age under 18 years old or greater than 75 years old
6. Pregnant women (as determined by point-of-care serum bHCG)
7. Intolerance/allergy to local anesthetics
8. Weight \<50 kg
9. Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
10. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
11. 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.
12. BMI \>50 kg/m2.
13. Allergy or contraindication to local anesthetics or any component of the multimodal analgesic regimen
(NSAIDs and acetaminophen)
14. Contraindication to spinal injection
Contacts
No contact information available.
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