Skip to content

Flex Appeal: Evaluating the Efficacy of Anesthetic Techniques for Manipulation of Knees Under Anesthesia

Flex Appeal: A Prospective Randomized Controlled Trial Evaluating the Efficacy of Anesthetic Techniques for Manipulation of Knees Under Anesthesia (MUA)

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07348614
Enrollment
128
Registered
2026-01-16
Start date
2026-03-01
Completion date
2027-09-01
Last updated
2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Stiffness After Total Knee Arthroplasty

Keywords

knee arthroplasty, spinal anesthesia, general anesthesia

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.

Interventions

PROCEDURESpinal Anesthesia

Administration of spinal anesthesia for knee manipulation.

PROCEDUREGeneral Anesthesia

Administration of general anesthesia for knee manipulation.

DRUGPropofol

Patients undergoing general anesthesia will receive an induction dose of propofol that will be titrated to effect, and airway support as needed until the patient is appropriately anesthetized for the procedure as determined by the anesthesia and surgical care teams.

Patients undergoing spinal anesthesia will receive a spinal injection under standard aseptic technique, with 45mg chloroprocaine.

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Investigator and surgeon will be masked

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Change in degrees of motion of the affected kneeAt time of procedure completion

Secondary

MeasureTime frameDescription
Change in painBaseline, 24 hours, 48 hours, 72 hours post-procedureParticipants will be asked to rate pain on a scale of 0-10 with 0 being no pain and 10 being the worst possible pain.
Opioid use in PACUDay 3

Contacts

PRINCIPAL_INVESTIGATOREmily Hall

Duke University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026