My Anesthesia Choice for Hip Fracture

Recruiting at 5 trial locations

Overseen By James Baraldi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must not be taking: Anticoagulants

Disqualifiers: Coagulopathy, Critical aortic stenosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

3548 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this study is to assess the implementation process for and the effectiveness of a quality improvement (QI) strategy to increase shared decision-making around anesthesia options for hip fracture surgery at 6 US hospitals. The QI strategy is to be facilitated by a clinician-administered 1-page bedside conversation aid designed to improve the quality of physician-patient communication, paired with brief clinician training. The evaluation will occur via a stepped wedge, cluster randomized trial to be carried out over a period of 27 months.

Do I need to stop taking my current medications for the trial?

The trial does not specify whether you need to stop taking your current medications. However, if you are on anticoagulant therapy (blood thinners), you may not be eligible to participate.

What data supports the effectiveness of the treatment My Anesthesia Choice-HF Model, MAC-HF for hip fracture?

Research suggests that the type of anesthesia used in hip fracture surgeries can impact patient outcomes, such as survival rates and surgical results, especially in older adults. Studies have shown that using certain types of anesthesia, like neuraxial anesthesia, may improve survival rates in hospitals where it is used more frequently. ^{1 2 3 4 5}

Is My Anesthesia Choice for Hip Fracture safe for humans?

Research comparing spinal and general anesthesia for hip fracture surgery suggests that spinal anesthesia may be associated with lower risks of postoperative complications and death compared to general anesthesia, indicating a favorable safety profile for spinal anesthesia in this context. ^{2 3 6 7 8}

How does the 'My Anesthesia Choice for Hip Fracture' treatment differ from other treatments for hip fracture?

The 'My Anesthesia Choice for Hip Fracture' treatment may involve a more minimally invasive anesthesia technique, such as multiple nerve blocks, which can offer better hemodynamic stability (stable blood pressure and heart function) compared to traditional methods like general or spinal anesthesia. This approach is particularly beneficial for elderly patients who are at high risk of complications during surgery. ^{1 6 9 10 11}

Research Team

Mark Neuman, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for patients with different types of hip fractures who are about to undergo surgery. The study aims to include a diverse group, but specific eligibility details aren't provided.

Inclusion Criteria

I am 50 years old or older.

I am scheduled for surgery to fix a broken hip.

Exclusion Criteria

I cannot have spinal anesthesia due to severe aortic valve narrowing.

I do not have a skin infection on my lower back.

I cannot have spinal anesthesia due to blood thinners or bleeding disorders.

Timeline

Pre-Implementation

Data collection on selected outcome variables will occur but no interventions will be delivered

Varies across sequences

Active Implementation

Site clinicians undergo training in use of the My Anesthesia Choice-HF tool, which is made available for use in clinical areas with eligible patients

12 months

Sustainment

The tool remains available for use and outcomes continue to be measured to assess sustainment of the intervention over time

Varies across sequences

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 to 90 days

Treatment Details

Interventions

• My Anesthesia Choice-HF Model

Trial Overview The study tests a new approach called 'My Anesthesia Choice-HF Model' designed to improve discussions between doctors and patients about anesthesia options before hip fracture surgery at six hospitals in the US.

Participant Groups

Group I: Usual Care Active Control 1 Intervention

Usual care will be delivered at each site during the pre-intervention phase. Patients treated in this arm will undergo pre-anesthesia care discussions as per existing clinical routine at each site.

Group II: My Anesthesia Choice- HF Active Control 1 Intervention

During the intervention and sustainment phases, site clinicians will receive standardized in-personal or virtual training on shared decision making theory and approaches. The My Anesthesia Choice-HF tool will be made available for use during preoperative conversations. Clinicians will receive encouragement to use the tool on study-eligible patients based on their assessment of clinical appropriateness.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Wake Forest University Health Sciences

Collaborator

Trials

1,432

Recruited

2,506,000+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

Dartmouth-Hitchcock Medical Center

Collaborator

Trials

548

Recruited

2,545,000+

Henry Ford Health System

Collaborator

Trials

334

Recruited

2,197,000+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Findings from Research

A survey of 423 Finnish anesthesiologists revealed that the majority use spinal blocks for intraoperative anesthesia in hip fracture patients, with 98% employing this method, indicating a strong preference for regional anesthesia over general anesthesia.

Preoperative pain management primarily involves oxycodone and paracetamol, with a significant number of anesthesiologists also using epidural infusions, suggesting a need for further research into personalized analgesia strategies for improved patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A national survey into perioperative anesthetic management of patients with a fractured neck of femur. Soinikoski, M., Kuusniemi, K., Jalonen, J., et al.[2021]

In a study of 16,695 older patients undergoing hip fracture surgery, regional anesthesia (RA) was associated with lower in-hospital mortality and better discharge outcomes compared to general anesthesia (GA), suggesting RA may be a safer option for this population.

Patients receiving GA had a higher risk of in-hospital mortality and longer hospital stays, while those who required conversion from regional to general anesthesia experienced even worse outcomes, highlighting the potential risks of GA in geriatric hip fracture surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Anesthesia on Hospital Mortality and Morbidities in Geriatric Patients Following Emergency Hip Fracture Surgery. Qiu, C., Chan, PH., Zohman, GL., et al.[2019]

In a study of 23,649 geriatric patients (ages 65-89) undergoing hip fracture surgery, spinal anesthesia (SA) was associated with a 21% lower risk of complications compared to general anesthesia (GA).

Patients receiving SA were also more likely to be discharged home after surgery, indicating a potentially better recovery outcome compared to those who received GA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Spinal Anesthesia in Geriatric Hip Fracture: A Propensity-Matched Study. Rodkey, DL., Pezzi, A., Hymes, R.[2023]

In a study of 107,317 patients over 12 years, 53.2% received neuraxial anesthesia for hip fracture surgery, highlighting significant variation in anesthesia type based on patient, anesthesiologist, and hospital factors.

Most of the variation in neuraxial anesthesia use (60.1%) was linked to patient characteristics, but 40% was influenced by the practices of anesthesiologists and hospitals, indicating that improving anesthesia practices will require addressing both patient needs and provider behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital-, Anesthesiologist-, and Patient-level Variation in Primary Anesthesia Type for Hip Fracture Surgery: A Population-based Cross-sectional Analysis. McIsaac, DI., Wijeysundera, DN., Bryson, GL., et al.[2019]

In a study of 73,284 adults undergoing hip fracture surgery, the type of anesthesia used (general, regional, or combined) did not significantly affect the risk of in-hospital mortality, with mortality rates being similar across all groups.

The analysis suggests that any potential benefits of regional anesthesia on reducing short-term mortality are likely to be modest, as the risk ratios for regional and combined anesthesia compared to general anesthesia were not significantly different.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative safety of anesthetic type for hip fracture surgery in adults: retrospective cohort study. Patorno, E., Neuman, MD., Schneeweiss, S., et al.[2022]

Spinal anesthesia (SA) resulted in a more stable hemodynamic profile for elderly patients undergoing hip fracture repair, requiring fewer interventions to maintain mean arterial pressure (MAP) compared to general anesthesia (GA).

While both SA and GA groups experienced hypotension after induction, the causes differed: SA's hypotension was mainly due to a decline in systemic vascular resistance, whereas GA's was primarily due to reductions in cardiac index and stroke volume.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodynamic changes associated with spinal and general anesthesia for hip fracture surgery in severe ASA III elderly population: a pilot trial. Messina, A., Frassanito, L., Colombo, D., et al.[2022]

In a study of 45,874 patients undergoing hip fracture surgery, neuraxial anesthesia was associated with lower rates of postoperative complications (11.0%) compared to general anesthesia (12.9%).

After adjusting for various factors, general anesthesia was found to significantly increase the risk of postoperative morbidity (19% higher) and mortality (9% higher) compared to neuraxial anesthesia, suggesting that neuraxial anesthesia may lead to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

General versus Neuraxial Anesthesia on Clinical Outcomes in Patients Receiving Hip Fracture Surgery: An Analysis of the ACS NSQIP Database. Wang, MT., Chang, CC., Liu, CC., et al.[2023]

In a study of 741 elderly patients who underwent hip fracture repair, general anesthesia was found to be at least as effective as spinal anesthesia for achieving good long-term outcomes.

The study included detailed evaluations of functional status and pain over 24 months, suggesting that general anesthesia may even provide better long-term results compared to spinal anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal anesthesia versus general anesthesia for hip fracture repair: a longitudinal observation of 741 elderly patients during 2-year follow-up. Gilbert, TB., Hawkes, WG., Hebel, JR., et al.[2010]

The use of an ultrasound-guided 'hourglass-pattern' fascia iliac block combined with sacral plexus and gluteal nerve blocks provided effective anesthesia for a high-risk elderly patient undergoing hip fracture surgery, demonstrating a minimally invasive approach.

This anesthesia technique resulted in successful surgery without any perioperative complications, highlighting its safety and efficacy in enhancing recovery for vulnerable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided "hourglass-pattern" fascia iliac block combined with sacral plexus and gluteal epithelial nerve block for an elderly hip fracture patient with organ failure. Wang, H., Li, Q., Ni, Y.[2022]

In a study of 593 elderly patients undergoing hip fracture surgery, general anaesthesia (GA) was associated with significantly higher rates of intraoperative hypotension compared to continuous spinal anaesthesia (CSA) and multiple nerve blocks (MNB), indicating that CSA and MNB provide better haemodynamic stability.

Despite the improved stability with CSA and MNB, the overall mortality rates and postoperative complications did not differ significantly between the anaesthesia techniques, suggesting that while hypotension is reduced, it does not impact mortality outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of multiple nerves blocks anaesthesia on intraoperative hypotension and mortality in hip fracture surgery intermediate-risk elderly patients: A propensity score-matched comparison with spinal and general anaesthesia. Mounet, B., Choquet, O., Swisser, F., et al.[2022]

Using a minidose of 4 mg bupivacaine combined with 20 micrograms of fentanyl for spinal anesthesia in elderly patients undergoing hip fracture surgery resulted in significantly less hypotension compared to the standard dose of 10 mg bupivacaine.

Only one patient in the minidose group required blood pressure support, while nine patients in the standard dose group needed significant vasopressor intervention, highlighting the efficacy and safety of the minidose approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minidose bupivacaine-fentanyl spinal anesthesia for surgical repair of hip fracture in the aged. Ben-David, B., Frankel, R., Arzumonov, T., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

A national survey into perioperative anesthetic management of patients with a fractured neck of femur. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Impact of Anesthesia on Hospital Mortality and Morbidities in Geriatric Patients Following Emergency Hip Fracture Surgery. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of Spinal Anesthesia in Geriatric Hip Fracture: A Propensity-Matched Study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Hospital-, Anesthesiologist-, and Patient-level Variation in Primary Anesthesia Type for Hip Fracture Surgery: A Population-based Cross-sectional Analysis. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Comparative safety of anesthetic type for hip fracture surgery in adults: retrospective cohort study. [2022]

6. Italy pubmed.ncbi.nlm.nih.gov

Hemodynamic changes associated with spinal and general anesthesia for hip fracture surgery in severe ASA III elderly population: a pilot trial. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

General versus Neuraxial Anesthesia on Clinical Outcomes in Patients Receiving Hip Fracture Surgery: An Analysis of the ACS NSQIP Database. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Spinal anesthesia versus general anesthesia for hip fracture repair: a longitudinal observation of 741 elderly patients during 2-year follow-up. [2010]

9. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-guided "hourglass-pattern" fascia iliac block combined with sacral plexus and gluteal epithelial nerve block for an elderly hip fracture patient with organ failure. [2022]

10. France pubmed.ncbi.nlm.nih.gov

Impact of multiple nerves blocks anaesthesia on intraoperative hypotension and mortality in hip fracture surgery intermediate-risk elderly patients: A propensity score-matched comparison with spinal and general anaesthesia. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Minidose bupivacaine-fentanyl spinal anesthesia for surgical repair of hip fracture in the aged. [2022]