NCT07348614 Flex Appeal: Evaluating the Efficacy of Anesthetic Techniques for Manipulation of Knees Under Anesthesia
| NCT ID | NCT07348614 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Duke University |
| Condition | Knee Stiffness After Total Knee Arthroplasty |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 128 participants in total. It began in 2026-06-01 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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
Contact & Investigator
Emily Hall
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT07348614 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Knee Stiffness After Total Knee Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07348614 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07348614 currently recruiting?
Yes, NCT07348614 is actively recruiting participants. Visit ClinicalTrials.gov or contact Duke University to inquire about joining.
Where is the NCT07348614 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT07348614 clinical trial?
NCT07348614 is sponsored by Duke University. The principal investigator is Emily Hall at Duke University. The trial plans to enroll 128 participants.