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

NCT07348614 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: Pro00118605
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Stiffness After Total Knee Arthroplasty

Keywords

knee arthroplasty; spinal anesthesia; general anesthesia

Outcome Measures

Primary Outcomes (1)

• Change in degrees of motion of the affected knee

  At time of procedure completion

Secondary Outcomes (2)

• Change in pain

  Baseline, 24 hours, 48 hours, 72 hours post-procedure

• Opioid use in PACU

  Day 3

Study Arms (2)

Spinal Anesthesia

EXPERIMENTAL

Patients receive spinal anesthesia during MUA (manipulation under anesthesia).

Procedure: Spinal Anesthesia; Drug: Chloroprocaine

General Anesthesia

ACTIVE COMPARATOR

Patients receive general anesthesia during MUA (manipulation under anesthesia).

Procedure: General Anesthesia; Drug: Propofol

Interventions

Spinal Anesthesia PROCEDURE

Administration of spinal anesthesia for knee manipulation.

Spinal Anesthesia

General Anesthesia PROCEDURE

Administration of general anesthesia for knee manipulation.

General Anesthesia

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.

General Anesthesia

Chloroprocaine DRUG

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

Spinal Anesthesia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Interventions

Anesthesia, Spinal; Anesthesia, General; Propofol; chloroprocaine

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Emily Hall

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Investigator and surgeon will be masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 16, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share