The Effect of Application of Fascia Iliaca Compartment Block (FICB) Before or After Spinal Anesthesia on QoR-15 Score in Partial Hip Arthroplasty Surgery
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
- Change from baseline QoR-15 at 24 hours postoperatively
研究概览
简要总结
It reduces pain scores in patients with block and improves the quality of recovery in the postoperative period. In patients who will undergo spinal anesthesia, it will be questioned whether the application of the block before or after surgery makes a difference in the quality of recovery.
详细描述
American Society of Anesthesiologists (ASA) physical status I-III patients who are planned for partial hip arthroplasty will be studied in patients over 65 years of age. The patients will be equally randomized into two groups using a computer-generated random number table. In the preoperative period, according to whether FIBP was before or after spinal anesthesia, it will be named as a separate group as Group PreS (Pre-Spinal) and Group PostS (Post-Spinal). The patient will be placed in the lateral decubitus position with the fractured side up. After the spinal anesthesia method was provided with aseptic conditions, 10 mg 0.5% isobaric bupivacaine + 20 mcg Fentanyl injection will be applied using a 26 Gauge pencil point needle through the L3-L4 or L4-L5 intervertebral space. After the patients are in the supine position and aseptic conditions are provided, the fascia on the Iliacus muscle will be determined with the help of an 8-12 MHz linear probe, and the block will be applied with the in-plane technique. During the block, patients will routinely administer 0.2% bupivacaine concentration of 0.5 mL/kg. Demographic data, operation time, perioperative analgesic and sedation need, postoperative pain scores, additional analgesic need, hospitalization and 24th-hour recovery scores will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
After each patient's eligibility has been assessed, numbered and sealed envelopes will be used to conceal assignment status. The same clinician (E.M.) will perform the patient's pre- and post-operative procedures. A researcher who does not know which method was applied to the patient in the perioperative and postoperative follow-ups will be included as double-blind.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Partial Hip Arthroplasty
- •American Society of Anesthesiologists (ASA) physical status I-III,
- •Patients aged ≥ 65 years
- •Exclusion criteria:
- •Contraindication for central or peripheral blocks,
- •Cognitive Dysfunction,
- •History of chronic opioid use,
- •Previous hip surgery,
- •Serious organ dysfunction,
- •Allergy to any drug used in the study,
- •Body mass index (BMI) ≥30,
- •Infection in the area to be treated,
- •Refusal to participate in the study
排除标准
- 未提供
研究组 & 干预措施
Group PreS
The block will be applied in the preoperative period
干预措施: Bupivacain (preoperative) (Drug)
Group PreS
The block will be applied in the preoperative period
干预措施: Bupivacaine-fentanyl (Drug)
Group PostS
The block will be applied in the postoperative period
干预措施: Bupivacaine-fentanyl (Drug)
Group PostS
The block will be applied in the postoperative period
干预措施: Bupivacain (Postoperative) (Drug)
结局指标
主要结局
Change from baseline QoR-15 at 24 hours postoperatively
时间窗: Postoperative 24th-hours
The patient-reported Turkish QoR-15 score includes 15 questions that evaluate the patient's postoperative recovery. The QoR-15 score is grouped under two groups, A and B. A high QoR-15 score, a score between 0 (poor) and 10 (excellent) for each item, and a total score of 150 indicate better quality of recovery.
次要结局
- Change from baseline Nursing Delirium Screening Scale (N-DSS) at 24 hours postoperatively(Postoperative 24th-hours)
- Postoperative nausea and vomiting(Postoperative 24th hour)
- Analgesic consumption(Postoperative 24th hour)
研究者
Ergün Mendeş
Principal Investigator
Başakşehir Çam & Sakura City Hospital