RecruitingPhase 4NCT07348614

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)


Sponsor

Duke University

Enrollment

128 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

  • Patients ≥18 years presenting for a manipulation of knee joint under anesthesia.
  • ASA Classification I - III.
  • English speaking patients.

Exclusion Criteria15

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

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.

DRUGChloroprocaine

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


Locations(1)

Duke University Health System

Durham, North Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07348614