Flex Appeal: Evaluating the Efficacy of Anesthetic Techniques for Manipulation of Knees Under Anesthesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spinal Anesthesia, General Anesthesia, Propofol, Chloroprocaine.
- Who it may be relevant to
- Registry conditions: Knee Stiffness After Total Knee Arthroplasty. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Flex Appeal: A Prospective Randomized Controlled Trial Evaluating the Efficacy of Anesthetic Techniques for Manipulation of Knees Under Anesthesia (MUA)
Overview
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
- Procedure Spinal Anesthesia
Administration of spinal anesthesia for knee manipulation. - Procedure General Anesthesia
Administration of general anesthesia for knee manipulation. - Drug Propofol
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. - Drug Chloroprocaine
Patients undergoing spinal anesthesia will receive a spinal injection under standard aseptic technique, with 45mg chloroprocaine.
Primary outcome measures
- Change in degrees of motion of the affected knee [Time frame: At time of procedure completion]
Secondary outcome measures (2)
- Change in pain [Time frame: Baseline, 24 hours, 48 hours, 72 hours post-procedure]
- Opioid use in PACU [Time frame: Day 3]
Eligibility criteria
Inclusion:
- Patients ≥18 years presenting for a manipulation of knee joint under anesthesia.
- ASA Classification I - III.
- English speaking patients.
Exclusion:
- ASA 4 or 5
- Daily chronic opioid use (over 3 months of continuous opioid use).
- Inability to communicate pain scores or need for analgesia.
- Infection at the site of block placement
- Age under 18 years old or greater than 75 years old
- Pregnant women (as determined by point-of-care serum bHCG)
- Intolerance/allergy to local anesthetics
- Weight <50 kg
- Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
- 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.
- BMI >50 kg/m2.
- Allergy or contraindication to local anesthetics or any component of the multimodal analgesic regimen
(NSAIDs and acetaminophen)
- Contraindication to spinal injection
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Duke University Health System — Durham
Identifiers
NCT: NCT07348614 · Pro00118605