Recruiting

MAC-STILA

Sponsor:

NYU Langone Health

Code:

NCT07897656

Conditions

Hip Fracture Surgeries

Intertrochanteric Fracture

Femoral Hip Fracture

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Monitored Anesthesia Care (MAC)

Soft Tissue Infiltration with Local Anesthetic (STILA)

General Anesthesia

Study Details

Brief summary:

The purpose of this study is to establish preliminary efficacy of Monitored Anesthesia Care and Soft Tissue Infiltration with Local Anesthesia (MAC-STILA) on severity of post operative delirium and secondary outcomes in patients with and without cognitive impairment.

Conditions

Hip Fracture Surgeries

Intertrochanteric Fracture

Femoral Hip Fracture

Study ID

NCT07897656

Start date

Oct 27, 2026

Status verified date

Oct, 2026

Completion date

Feb 28, 2028

Anticipated

Primary completion date

Dec 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

\- Adults aged 65 years and older undergoing surgical repair for an intertrochanteric or femoral neck hip fracture are eligible for the study. Fracture fixation can be with cannulated screws, a sliding hip screw (or similar device), a short cephalomedullary nail, or a long cephalomedullary nail.

Exclusion Criteria:

  • Patients with pre-operative delirium;
  • Patients with a periprosthetic or peri implant fracture;
  • Patients at risk for malignant hyperthermia (history of malignant hyperthermia, family history of malignant hyperthermia susceptibility, history of rhabdomyolysis);
  • Patients with contraindication to local anesthesia;
  • considered unsuitable for randomization by the surgeon or anesthesiologist on the basis of the physician's clinical assessment (e.g. severe pulmonary disease);
  • treated with hip arthroplasty
  • received a preoperative peripheral nerve block; or
  • severe dementia defined as pre-operative MMSE score < 15.

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: MAC-STILA

Participants will receive monitored anesthesia care with soft-tissue infiltration with local anesthesia (MAC-STILA) during surgery.

active comparator: General Anesthesia

Participants will receive general anesthesia during surgery.

Interventions

Monitored Anesthesia Care (MAC)

Anesthesiologist titration of intravenous sedation to a level that preserves a natural airway with spontaneous breathing.

Soft Tissue Infiltration with Local Anesthetic (STILA)

Local anesthetic injected directly into the surgical site following sedation.

General Anesthesia

Participants will be sedated per general anesthesia procedures.

Primary outcome measure

  • Enrollment Rate [ Time Frame: End-of-study (up to 90 days) ]
  • Percentage of completeness of data collected [ Time Frame: End-of-study (up to 90 days) ]

Central Contacts and Locations

Central contacts

Shifa Ahmed

774-217-2467shifa.ahmed@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Oct 29, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-30. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-10-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.