Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
102 participants
INTERVENTIONAL
2024-02-29
2025-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
SINGLE
Study Groups
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Spinal Anesthesia
This arm gets preoperative single-dose spinal anesthesia plus an ultrasound-guided Fascia Iliaca Compartment Block (FICB).
Spinal 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.
General Anesthesia
This arm gets preoperative general anesthesia plus an ultrasound-guided Fascia Iliaca Compartment Block (FICB).
General 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.
Interventions
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Spinal 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.
General 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
89 Years
ALL
No
Sponsors
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Hartford Hospital
OTHER
Responsible Party
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Haleh Saadat
Associate Clinical Professor of Anesthesiology
Principal Investigators
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Haleh Saadat
Role: PRINCIPAL_INVESTIGATOR
Integrated Anesthesia Associates, LLC - Fairfield Division
Central Contacts
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References
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Parry SM, Puthucheary ZA. The impact of extended bed rest on the musculoskeletal system in the critical care environment. Extrem Physiol Med. 2015 Oct 9;4:16. doi: 10.1186/s13728-015-0036-7. eCollection 2015.
Tagliafico AS, Torri L, Signori A. Treatment of meralgia paresthetica (Lateral Femoral Cutaneous Neuropathy): A meta-analysis of ultrasound-guided injection versus surgery. Eur J Radiol. 2021 Jun;139:109736. doi: 10.1016/j.ejrad.2021.109736. Epub 2021 Apr 26.
Gupta G, Radhakrishna M, Tamblyn I, Tran DQ, Besemann M, Thonnagith A, Elgueta MF, Robitaille ME, Finlayson RJ. A randomized comparison between neurostimulation and ultrasound-guided lateral femoral cutaneous nerve block. US Army Med Dep J. 2017 Jul-Sep;(2-17):33-38.
Neuman MD, Feng R, Carson JL, Gaskins LJ, Dillane D, Sessler DI, Sieber F, Magaziner J, Marcantonio ER, Mehta S, Menio D, Ayad S, Stone T, Papp S, Schwenk ES, Elkassabany N, Marshall M, Jaffe JD, Luke C, Sharma B, Azim S, Hymes RA, Chin KJ, Sheppard R, Perlman B, Sappenfield J, Hauck E, Hoeft MA, Giska M, Ranganath Y, Tedore T, Choi S, Li J, Kwofie MK, Nader A, Sanders RD, Allen BFS, Vlassakov K, Kates S, Fleisher LA, Dattilo J, Tierney A, Stephens-Shields AJ, Ellenberg SS; REGAIN Investigators. Spinal Anesthesia or General Anesthesia for Hip Surgery in Older Adults. N Engl J Med. 2021 Nov 25;385(22):2025-2035. doi: 10.1056/NEJMoa2113514. Epub 2021 Oct 9.
O'Connor MI, Switzer JA. AAOS Clinical Practice Guideline Summary: Management of Hip Fractures in Older Adults. J Am Acad Orthop Surg. 2022 Oct 15;30(20):e1291-e1296. doi: 10.5435/JAAOS-D-22-00125. Epub 2022 Jun 17.
Wan HY, Li SY, Ji W, Yu B, Jiang N. Fascia Iliaca Compartment Block for Perioperative Pain Management of Geriatric Patients with Hip Fractures: A Systematic Review of Randomized Controlled Trials. Pain Res Manag. 2020 Nov 25;2020:8503963. doi: 10.1155/2020/8503963. eCollection 2020.
Cai L, Song Y, Wang Z, She W, Luo X, Song Y. The efficacy of fascia iliaca compartment block for pain control after hip arthroplasty: A meta-analysis. Int J Surg. 2019 Jun;66:89-98. doi: 10.1016/j.ijsu.2018.12.012. Epub 2019 Jan 24.
Brown MT, Brangman SA, Smith NH. Early Identification of Cognitive Impairment: Utility of the Mini-Cog in Non-Clinical Settings. J Appl Gerontol. 2023 Oct;42(10):2139-2147. doi: 10.1177/07334648231175606. Epub 2023 May 24.
Clevenger CK, Schlenger A, Gunter D, Glasgow GB. Cognitive assessment in primary care: Practical recommendations. Nurse Pract. 2023 Jul 1;48(7):26-35. doi: 10.1097/01.NPR.0000000000000067.
American Society of Anesthesiologists. Practice advisory for the management of perioperative hypersensitivity and allergic reactions: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Hypersensitivity and Allergic Reactions. Anesthesiology. 2020;133(1):169-192
Iwakiri M, Inoue R, Uchida K. Allergic reactions to propofol in adult patients with egg or soybean allergy: a retrospective cohort study from a large database of a single institute. JA Clin Rep. 2023 Jan 9;9(1):1. doi: 10.1186/s40981-022-00591-8.
Apfelbaum JL, Silverstein JH, Chung FF, Connis RT, Fillmore RB, Hunt SE, Nickinovich DG, Schreiner MS, Silverstein JH, Apfelbaum JL, Barlow JC, Chung FF, Connis RT, Fillmore RB, Hunt SE, Joas TA, Nickinovich DG, Schreiner MS; American Society of Anesthesiologists Task Force on Postanesthetic Care. Practice guidelines for postanesthetic care: an updated report by the American Society of Anesthesiologists Task Force on Postanesthetic Care. Anesthesiology. 2013 Feb;118(2):291-307. doi: 10.1097/ALN.0b013e31827773e9. No abstract available.
Ganesh R, Kebede E, Mueller M, Gilman E, Mauck KF. Perioperative Cardiac Risk Reduction in Noncardiac Surgery. Mayo Clin Proc. 2021 Aug;96(8):2260-2276. doi: 10.1016/j.mayocp.2021.03.014. Epub 2021 Jul 3.
Yajnik M, Kou A, Mudumbai SC, Walters TL, Howard SK, Edward Kim T, Mariano ER. Peripheral nerve blocks are not associated with increased risk of perioperative peripheral nerve injury in a Veterans Affairs inpatient surgical population. Reg Anesth Pain Med. 2019 Jan;44(1):81-85. doi: 10.1136/rapm-2018-000006.
Neal JM, Barrington MJ, Brull R, Hadzic A, Hebl JR, Horlocker TT, Huntoon MA, Kopp SL, Rathmell JP, Watson JC. The Second ASRA Practice Advisory on Neurologic Complications Associated With Regional Anesthesia and Pain Medicine: Executive Summary 2015. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):401-30. doi: 10.1097/AAP.0000000000000286.
Related Links
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Hip fractures from American Academy of orthopedic Surgeons (AAOS).Cited 2023 May 21
Other Identifiers
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HHC-2023-0269.
Identifier Type: -
Identifier Source: org_study_id
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