Hypobaric Spinal or Hyperbaric in Partial Hip Arthroplasty Surgeries? Can an Answer be Found by Perfusion Index?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual analog pain score (VAS)
研究概览
简要总结
The aim of this study was to compare the effects of hypobaric and hyperbaric spinal applications on patient haemodynamics, duration of anaesthetic effect and postoperative analgesia. Thus, it was aimed to determine the method that protects haemodynamics more and suppresses postoperative pain complaints of patients better in this patient group with advanced age, comorbid systemic diseases and high risk of operation.
详细描述
Patients who are planned to be operated for partial hip replacement at Adıyaman University Training and Research Hospital, who are informed about the study and who agree to participate in the study with their written consent will be included in the study.
Patients who agree to participate in the study will be divided into two groups: hypobaric and hyperbaric spinal anaesthesia patients will be divided into two groups to be decided by the Anaesthesiology and Reanimation specialist responsible for the operation (hyperbaric/hypobaric). Before the start of the operation, perfusion index (PI) values will be monitored with a probe in both lower extremities with standard ASA monitoring. Haemodynamic values (blood pressure arterial, peak heart rate, peripheral oxygen saturation), PI values of both extremities, duration of motor and sensory block, postoperative numeric pain scores of all patients will be recorded and these values will be compared in both groups.
Thus, it was aimed to compare the efficacy, safety, block times and contribution to pain management of each application.
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
- Double (Participant, Outcomes Assessor)
盲法说明
for patient - closed envelope system for Outcomes Assessor - will not participate perioperative period and will not know group of patients
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 aged
排除标准
- •ASA III-IV
- •Deny to participiate
- •conditions that spinal anesthesia contraindicated
- •use of alpha or beta-blockers
- •allergy to local anesthetics
- •diabetes mellitus
- •peripheral vascular disease (The following exclusion criteria were added to ensure patient safety and to avoid confounding factors that could interfere with perfusion index measurements or hemodynamic responses: use of alpha or beta-blockers, diabetes mellitus, and peripheral vascular disease. These conditions may significantly alter autonomic regulation, vascular tone, or peripheral circulation, potentially affecting perfusion index values or increasing the risk of adverse reactions to spinal anesthesia)
研究组 & 干预措施
Hyberbaric group
In this group, hyperbaric bupivacaine was planned to use in spinal anesthesia for partial hip replacement surgery
干预措施: spinal anesthesia with hyberbaric bupivacaine (Procedure)
Hypobaric group
In this group, hypobaric bupivacaine was planned to use in spinal anesthesia for partial hip replacement surgery
干预措施: spinal anesthesia with hypobaric bupivacaine (Procedure)
结局指标
主要结局
Visual analog pain score (VAS)
时间窗: First postoperative 24 hours (The originally registered follow-up period of 3 months was entered in error. The intended and actual outcome assessment period for this study is the first 24 postoperative hours.)
a tool that asses patinet paiin level 0 (no pain) -10 (the worst pain ever had) , the tool will be used at postopertaive period
次要结局
- Quality of recovery (QoR-15)(first postoperative24 hours(The originally registered follow-up period of 3 months was entered in error. The intended and actual outcome assessment period for this study is the first 24 postoperative hours, as correctly stated in the description section))
研究者
Nezir Yılmaz
Associate Professor,MD
Adiyaman University Research Hospital