Hip FracturesNCT06249789
Enhancing Recovery in Hip Fracture Surgeries
A study testing Spinal Anesthesia and General Anesthesia in people with Hip Fractures, run by Hartford Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 89 years
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Spinal Anesthesia and General Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Hip Fractures
- Being tested
- Spinal Anesthesia, General Anesthesia
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal AnesthesiaProcedure or surgery
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 AnesthesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Anesthesia | Active comparator | This arm gets preoperative single-dose spinal anesthesia plus an ultrasound-guided Fascia Iliaca Compartment Block (FICB). Receives: Procedure: Spinal Anesthesia |
| General Anesthesia | Active comparator | This arm gets preoperative general anesthesia plus an ultrasound-guided Fascia Iliaca Compartment Block (FICB). Receives: Procedure: General Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring Pain: Visual Analog Scale (VAS)
The pain scale ranges from 0, no pain, to 10, the worst pain imaginable.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: We measure at two point 1) Pre-operative 2) on post operative day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haleh Saadat, Hartford Hospital
- Investigators
- Haleh Saadat, Principal investigator, Integrated Anesthesia Associates, LLC - Fairfield Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249789
- Sponsor's protocol ID
- HHC-2023-0269.
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 26457181Tagliafico 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.
PubMed 33933838Gupta 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.
PubMed 28853117Neuman 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.
PubMed 34623788O'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.
PubMed 36200817Wan 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.
PubMed 33294087Cai 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.
PubMed 30685517Brown 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.
PubMed 37224462Clevenger 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.
PubMed 37368555American 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.
PubMed 36617591Apfelbaum 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.
PubMed 23364567Ganesh 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.
PubMed 34226028Yajnik 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.
PubMed 30640657Neal 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.
PubMed 26288034
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Recovery in Hip Fracture Surgeries
- ClinicalTrials.gov ID
- NCT06249789
- Acronym / sponsor ID
- HHC-2023-0269.
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Spinal Anesthesia | Active comparator | Procedure: Spinal AnesthesiaThis arm gets preoperative single-dose spinal anesthesia plus an ultrasound-guided Fascia Iliaca Compartment Block (FICB). |
| General Anesthesia | Active comparator | Procedure: General AnesthesiaThis arm gets preoperative general anesthesia plus an ultrasound-guided Fascia Iliaca Compartment Block (FICB). |
Who may qualify
- Ages
- 60 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal AnesthesiaParticipants 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. | Procedure or surgery | Spinal Anesthesia |
| General AnesthesiaParticipants 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. | Procedure or surgery | General Anesthesia |
Primary outcome
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.
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.
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.
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.
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.
1 secondary outcome
Cognitive impairment and delirium
Time frame: We measure at two point 1) Pre-operative 2) on post operative day one
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Background: PubMed 26457181Parry 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.
- Background: PubMed 33933838Tagliafico 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.
- Background: PubMed 28853117Gupta 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.
- Background: PubMed 34623788Neuman 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.
- Background: PubMed 36200817O'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.
- Background: PubMed 33294087Wan 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.
- Background: PubMed 30685517Cai 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.
- Background: PubMed 37224462Brown 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.
- Background: PubMed 37368555Clevenger 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.
- BackgroundAmerican 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: PubMed 36617591Iwakiri 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.
- Background: PubMed 23364567Apfelbaum 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.
- Hip fractures from American Academy of orthopedic Surgeons (AAOS).Cited 2023 May 21Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haleh Saadat principal investigator
Integrated Anesthesia Associates, LLC - Fairfield Division
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Anesthesia and General Anesthesia in people with Hip Fractures, run by Hartford Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haleh Saadat (2036879984, haleh.saadat@hhchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06249789, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.