Flex Appeal: Does the anesthesia type change outcomes after knee manipulation under anesthesia?
Official title: Flex Appeal: A Prospective Randomized Controlled Trial Evaluating the Efficacy of Anesthetic Techniques for Manipulation of Knees Under Anesthesia (MUA)
Run by Duke University · NCT07348614 · Data updated 2026-11-12
This study tests whether using spinal anesthesia versus general anesthesia improves pain control and results after knee manipulation following knee replacement.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 128 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | June 1, 2026 |
| Main results expected | August 2027 |
| Study ends | September 2027 |
| Registry record updated | June 3, 2026 |
| Trial ID | NCT07348614 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 undergoing knee manipulation under anesthesia, with ASA I–III, who can communicate in English.
✕Probably not a fit
Patients with higher surgical risk (ASA IV–V), chronic opioid use, or contraindications to the anesthesia approaches may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized or comparative interventional study compares spinal anesthesia to general anesthesia for patients undergoing knee manipulation under anesthesia after total knee arthroplasty. It includes adults 18–75 with ASA I–III and English proficiency, excluding those with higher surgical risk, chronic opioid use, or contraindications to regional anesthesia. Interventions involve spinal or general anesthesia, with propofol and chloroprocaine used as part of the protocols. Outcomes focus on pain control and functional results after manipulation under anesthesia. The Duke University Health System serves as the lead site.
Why it matters
Potential benefit: If successful, the study could identify an anesthesia approach that provides better pain management and functional outcomes after knee manipulation.
How similar studies have gone: Prior research has explored anesthesia choice affecting perioperative pain, but results for knee manipulation under anesthesia are mixed and this study adds targeted evidence.
Who can join: the full rules
Show full inclusion / exclusion 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 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
Where it's running
-
Duke University Health System
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Emily Hall — Duke University
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.