Recruiting

Spinal vs. General

Sponsor:

Duke University

Code:

NCT07348614

Conditions

Knee Stiffness After Total Knee Arthroplasty

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Spinal Anesthesia

General Anesthesia

Propofol

Chloroprocaine

Study Details

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

Study ID

NCT07348614

Start date

Jun 1, 2026

Status verified date

Jan, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Spinal Anesthesia

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

active comparator: General Anesthesia

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

Interventions

Spinal Anesthesia

Administration of spinal anesthesia for knee manipulation.

General Anesthesia

Administration of general anesthesia for knee manipulation.

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.

Chloroprocaine

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

Primary outcome measure

  • Change in degrees of motion of the affected knee [ Time Frame: At time of procedure completion ]

Central Contacts and Locations

Locations

Duke University Health System

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Principal Investigator:

Emily Hall, MD

More Information

Sponsor

Duke University

Last update posted

Jun 3, 2026

Last verified

Jan, 2026

Keywords

  • knee arthroplasty
  • spinal anesthesia
  • general anesthesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-06-03.