An interventional study of Spinal Anesthesia and General Anesthesia in Hip Fractures, sponsored by Hartford Hospital. Not yet recruiting. Open to participants aged 60 Years to 89 Years. Per ClinicalTrials.gov, last updated 2024-02-08.
Sponsored by Hartford Hospital · Not applicable, Interventional, and Treatment
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:
Participants in the study will be put into one of two groups by chance to see if there's a difference in their recovery.
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:
Participants will:
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 102 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Hartford Hospital is the lead sponsor of 101 studies on the registry; 19 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients meeting all of the following criteria will be included:
Exclusion Criteria:
Patients meeting any of the following criteria will be excluded:
have absolute contraindications to spinal anesthesia, determined preoperatively by the regional anesthesiologist in charge, such as:
This arm gets preoperative single-dose spinal anesthesia plus an ultrasound-guided Fascia Iliaca Compartment Block (FICB).
Procedure: Spinal Anesthesia
This arm gets preoperative general anesthesia plus an ultrasound-guided Fascia Iliaca Compartment Block (FICB).
Procedure: General Anesthesia
Participants in this arm will receive single-shot spinal anesthesia with 12-15 mg of either 0.05% or 0.75% bupivacaine (iso or hyperbaric) once before surgery. Additionally, they will undergo an ultrasound-guided nerve block called the Fascia Iliaca Compartment Block (FICB ) in combination with spinal anesthesia.
Participants in this group will be given a combination of general anesthesia and a nerve block. General anesthesia involves the use of a sedative called propofol, along with devices to ensure that the airway remains open during the procedure. Additionally, they will undergo an ultrasound-guided nerve block known as the Fascia Iliaca Compartment Block (FICB) in combination with spinal anesthesia.
Measuring Pain: Visual Analog Scale (VAS)
The pain scale ranges from 0, no pain, to 10, the worst pain imaginable.
Time frame: Postoperative Anesthesia Unit (PACU) stay: Approximately 2-4 hours from arrival to PACU to release to the floor.
Post-anesthesia Care Unit (PACU) Opioid consumption
Post-anesthesia opioid use is measured in milligrams (Morphine Equivalent table) and tracked in the PACU to manage pain. Lower use suggests reasonable pain control; higher use indicates more pain and inadequate control.
Time frame: Approximately 2-4 hours: From the moment the patient arrives in the Post Anesthesia Care Unit (PACU) until their departure to the floor..
Post-Anesthesia Care Unit Stay
The Aldrete Score, used in the PACU, rates from 0 to 10 for discharge readiness. Higher scores mean patients' vital signs are stable; lower scores require more recovery time.
Time frame: Approximately 2-4 hours: From the moment the patient arrives in the Post Anesthesia Care Unit (PACU) until their departure to the floor..
Postoperative complications:
We are monitoring post-op complications like episodes of postoperative nausea and vomiting (PONV) with the "PONV impact Scale" in the postoperative care unit, the presence of infections, thrombosis (DVT), and pulmonary and heart issues. PONV will be assessed in PACU; a score ≥5 on the PONV Scale is significant.
Time frame: Monitoring for PONV, DVT, and cardiac/pulmonary issues occurs at 24, 48, and 72 hours post-admission for observation.
Post-Surgery Hospital Stay
The period between the end of the surgical procedure and hospital discharge.
Time frame: Post-surgery stay is hospital typically 7-10 days for recovery and complication management. Extended stays may signal recovery delays.
Cognitive impairment and delirium
The Mini-Cognitive Assessment Instrument (Mini-Cog) Test is a quick screening tool used to identify possible cases of cognitive impairment. It combines a three-item memory test and a clock-drawing task and is typically used in settings where time is a constraint. If a score below three is obtained, it raises concerns about dementia.
Time frame: We measure at two point 1) Pre-operative 2) on post operative day one
No study locations are listed for this record.
Plan to share: No — The investigators have decided not to share individual participant data from this study. This decision is based on the need to rigorously protect the privacy and confidentiality of our participants. Although sharing data can be beneficial for broader research purposes, our primary concern is ensuring that personal health information remains secure and private. Additionally, the specific nature of our study data may not easily lend itself to broader application without detailed context, which could be challenging to provide adequately in a data-sharing scenario.
This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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