Clinical trial NCT06249789: Enhancing Recovery in Hip Fracture Surgeries
Official title: Enhancing Recovery in Hip Fracture Surgeries
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hip Fractures
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 102
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Research Design \& Procedures: Patients will be categorized into two groups:

Arm A (spinal anesthesia):

Patients will receive an ultrasound-guided Fascia Iliaca Compartment Block (FICB) injection.

A single-shot spinal anesthetic will be administered. Propofol will be used for intraoperative sedation, ensuring patient responsiveness.

Fentanyl will be given as needed for pain relief.

Arm B (general anesthesia):

Patients will receive an ultrasound-guided Fascia Iliaca Compartment Block (FICB) injection.

A general anesthetic will be administered using appropriate airway management devices, with Propofol infusion for maintenance.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to look at how two different types of anesthesia, spinal and general, affect participants with broken hips who are getting a special kind of pain block before surgery.

Researchers will check:

* How quickly patients are ready for anesthesia
* How long they stay in the recovery room after surgery
* How much pain medicine they need during recovery
* If they experience any confusion
* If one group has complications in one of these anesthesia techniques?

Participants in the study will be put into one of two groups by chance to see if there's a difference in their recovery.

Detailed description: This clinical trial aims to compare two common anesthesia techniques, spinal and general anesthesia, combined with a preoperative nerve block called the Fascia Iliaca Compartment Block (FICB). The objective is to understand how these methods affect patients undergoing hip fracture surgery.

The main questions this study aims to answer are:

* Does the choice between spinal and general anesthesia influence how quickly patients recover from anesthesia?
* Does it affect how long patients stay in the Post-Anesthesia Care Unit (PACU)?
* Does it change the amount of opioid pain medication needed after surgery?
* Do the different anesthesia types impact the occurrence of postoperative delirium?
* Do they affect the length of the hospital stay after surgery?
* Do they lead to different rates of post-operative complications?

Participants will:

* Receive either spinal anesthesia with Fascia Iliaca Compartment Block (FICB) (Arm A) or general anesthesia with Fascia Iliaca Compartment Block (FICB) (Arm B).
* Undergo an ultrasound-guided FICB injection.
* Receive appropriate anesthesia and sedation during surgery.
* Be monitored for pain and provided with pain relief as needed.

The study's broader objectives include enhancing patient safety and satisfaction, reducing hospital readmission rates, lowering healthcare costs, and improving overall healthcare practices. Although direct benefits to participants are not guaranteed, the findings will inform better care for future patients with hip fractures.

Eligibility criteria: Inclusion Criteria:

Patients meeting all of the following criteria will be included:

* any gender
* any race/ethnicity
* age 60-89 years
* admitted to St Vincent's Medical Center (SVMC) for elective hip fracture: intramedullary (IM) nailing or open reduction internal fixation (ORIF)
* able to communicate in English or Spanish

Exclusion Criteria:

Patients meeting any of the following criteria will be excluded:

* age \<60 or ≥90 years old
* Body Mass Index (BMI) \>50 kg/m2
* not ambulatory prior to the fracture
* have a current daily Morphine Equivalent Dose (MED) surpassing 20-milligram equivalents (MME)
* communicate in a language other than English or Spanish (due to lack of availability of translators and issues with patient management if dependent on the Hartford Health Center (HHC) language line)
* history of substance abuse, which might interfere with anesthesia administration, pain management, and overall study outcomes
* have undergone previous hip surgery on the side of the fracture
* refusal to participate or lack of signed study informed consent from the patient or their proxy (in cases where patients lack the capacity to consent)
* have absolute contraindications to spinal anesthesia, determined preoperatively by the regional anesthesiologist in charge, such as:

  * suspected or known coagulopathy (congenital or acquired)
  * current usage of anticoagulant medication within a timeframe deemed inappropriate for neuraxial block by the American Society of Regional Anesthesia guidelines
  * unrepaired critical or severe aortic stenosis
  * active skin infection at the needle insertion site
  * elevated intracranial pressure precluding Dural puncture
* have an increased risk (assessed by reviewing the patient's medical record) for malignant hyperthermia (MH), such as patients with any prior personal or family history of MH or adverse reactions to anesthesia due to MH

Primary outcomes:
measure: Measuring Pain: Visual Analog Scale (VAS)
timeFrame: Postoperative Anesthesia Unit (PACU) stay: Approximately 2-4 hours from arrival to PACU to release to the floor.
measure: Post-anesthesia Care Unit (PACU) Opioid consumption
timeFrame: Approximately 2-4 hours: From the moment the patient arrives in the Post Anesthesia Care Unit (PACU) until their departure to the floor..
measure: Post-Anesthesia Care Unit Stay
timeFrame: Approximately 2-4 hours: From the moment the patient arrives in the Post Anesthesia Care Unit (PACU) until their departure to the floor..
measure: Postoperative complications:
timeFrame: Monitoring for PONV, DVT, and cardiac/pulmonary issues occurs at 24, 48, and 72 hours post-admission for observation.
measure: Post-Surgery Hospital Stay
timeFrame: Post-surgery stay is hospital typically 7-10 days for recovery and complication management. Extended stays may signal recovery delays.
Secondary outcomes:
measure: Cognitive impairment and delirium
timeFrame: We measure at two point 1) Pre-operative 2) on post operative day one
Other outcomes:
Locations:
Study officials:
affiliation: Integrated Anesthesia Associates, LLC - Fairfield Division
name: Haleh Saadat
role: PRINCIPAL_INVESTIGATOR
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