Enhancing Recovery in Hip Fracture Surgeries

February 6, 2024 updated by: Haleh Saadat, Hartford Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Spinal Anesthesia
This arm gets preoperative single-dose spinal anesthesia plus an ultrasound-guided Fascia Iliaca Compartment Block (FICB).
Procedure: 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.
Active Comparator: General Anesthesia
This arm gets preoperative general anesthesia plus an ultrasound-guided Fascia Iliaca Compartment Block (FICB).
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring Pain: Visual Analog Scale (VAS)
Time Frame: Postoperative Anesthesia Unit (PACU) stay: Approximately 2-4 hours from arrival to PACU to release to the floor.
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
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 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
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..
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:
Time Frame: Monitoring for PONV, DVT, and cardiac/pulmonary issues occurs at 24, 48, and 72 hours post-admission for observation.
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
Time Frame: Post-surgery stay is hospital typically 7-10 days for recovery and complication management. Extended stays may signal recovery delays.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive impairment and delirium
Time Frame: We measure at two point 1) Pre-operative 2) on post operative day one
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.
We measure at two point 1) Pre-operative 2) on post operative day one

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hartford Hospital

Investigators

  • Principal Investigator: Haleh Saadat, Integrated Anesthesia Associates, LLC - Fairfield Division

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

January 25, 2024

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHC-2023-0269.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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