NCT07348614PHASE4Recruiting
Flex Appeal: Evaluating the Efficacy of Anesthetic Techniques for Manipulation of Knees Under Anesthesia
Duke University
Start Date
6/1/2026
Completion Date
9/1/2027
Summary
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.
Eligibility Criteria
Age Range: 18 years to 75 years
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
Interventions
PROCEDURE
Spinal Anesthesia
PROCEDURE
General Anesthesia
DRUG
Propofol
DRUG
Chloroprocaine
Conditions
Knee Stiffness After Total Knee Arthroplasty
Locations
Duke University Health System
Durham, North Carolina 27705
United States