Enhancing Recovery in Hip Fracture Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 102
- 主要终点
- Measuring Pain: Visual Analog Scale (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome evaluators and analysts would be unaware of which treatment the participants received.
入排标准
- 年龄范围
- 60 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Measuring Pain: Visual Analog Scale (VAS)
时间窗: 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 Stay
时间窗: 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:
时间窗: 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-anesthesia Care Unit (PACU) Opioid consumption
时间窗: 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-Surgery Hospital Stay
时间窗: 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.
次要结局
- Cognitive impairment and delirium(We measure at two point 1) Pre-operative 2) on post operative day one)
研究者
Haleh Saadat
Associate Clinical Professor of Anesthesiology
Hartford Hospital