Enhancing Recovery in Hip Fracture Surgeries

NCT06249789 | Not Yet Recruiting DMC

• 1 other identifier: HHC-2023-0269.
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (5)

• Measuring Pain: Visual Analog Scale (VAS)

  The pain scale ranges from 0, no pain, to 10, the worst pain imaginable.

  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.

  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.

  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.

  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.

  Post-surgery stay is hospital typically 7-10 days for recovery and complication management. Extended stays may signal recovery delays.

Secondary Outcomes (1)

• Cognitive impairment and delirium

  We measure at two point 1) Pre-operative 2) on post operative day one

Study Arms (2)

Spinal Anesthesia

ACTIVE COMPARATOR

This arm gets preoperative single-dose spinal anesthesia plus an ultrasound-guided Fascia Iliaca Compartment Block (FICB).

Procedure: Spinal Anesthesia

General Anesthesia

ACTIVE COMPARATOR

This arm gets preoperative general anesthesia plus an ultrasound-guided Fascia Iliaca Compartment Block (FICB).

Procedure: General Anesthesia

Interventions

Spinal Anesthesia PROCEDURE

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.

Spinal Anesthesia

General Anesthesia PROCEDURE

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.

General Anesthesia

Eligibility Criteria

• Age: 60 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartford Hospital: lead

Related Publications (15)

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• 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.

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• 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.

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• 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.

  PMID: 33294087 BACKGROUND

• 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.

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• 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.

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• 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.

  PMID: 37368555 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 36617591 BACKGROUND

• 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.

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Related Links

• Hip fractures from American Academy of orthopedic Surgeons (AAOS).Cited 2023 May 21

MeSH Terms

Conditions

Hip Fractures

Interventions

Anesthesia, Spinal; Anesthesia, General

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Haleh Saadat

  Integrated Anesthesia Associates, LLC - Fairfield Division

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haleh Saadat

CONTACT

2036879984; haleh.saadat@hhchealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome evaluators and analysts would be unaware of which treatment the participants received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor of Anesthesiology

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 8, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: May 1, 2025
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share