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NCT Number: NCT07348614

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Duke University Health System

Durham, North Carolina, 27705, United States

Location status: Recruiting

Location contact

Emily Hall, MD

CONTACT

[email protected]

919-681-0880

Emily Hall, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal anesthesia

Procedure

Administration of spinal anesthesia for knee manipulation.

General Anesthesia

Procedure

Administration of general anesthesia for knee manipulation.

Propofol

Drug

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.

Chloroprocaine

Drug

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

Primary outcomes

  1. Change in degrees of motion of the affected knee

    Time frame: At time of procedure completion

Secondary outcomes

  1. Change in pain

    Time frame: Baseline, 24 hours, 48 hours, 72 hours post-procedure

    Participants will be asked to rate pain on a scale of 0-10 with 0 being no pain and 10 being the worst possible pain.

  2. Opioid use in PACU

    Time frame: Day 3

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 16, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.