The Effects of Regional Anesthesia Methods on the Quality of Recovery in Radiofrequency Ablation of Varicose Veins
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- QUALITY OF RECOVERY- 40
研究概览
简要总结
This prospective observational study aims to compare the effects of spinal anesthesia and supra-inguinal fascia iliac block (SIFIB) on the quality of postoperative recovery in endovenous radiofrequency ablation (RFA) of varicose veins. The primary outcome measure of the study is the QoR-40 quality of recovery score. Secondary outcome measures include postoperative pain scores (VAS/NRS), motor block level (Bromage Scale), perfusion index (PI), time to first mobilization, and patient and surgeon satisfaction.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •Age Profile: Adults aged between 18 and 65 years.
- •Physical Status: Patients classified as American Society of Anesthesiologists (ASA) Physical Status I, II, or III.
- •Informed Consent: Patients who voluntarily agreed to participate and provided written informed consent.
- •Cognitive Status: Patients who were conscious, oriented, and capable of cooperating with the pain assessment scales (NRS) and the QoR-40 questionnaire.
排除标准
- •Venous Pathology: Presence of deep venous insufficiency (e.g., iliac or femoral vein obstruction, iliac vein stenosis) or acute deep vein thrombosis (DVT) in the lower extremity.
- •Systemic Diseases: Combined cardiac, pulmonary, hepatic, or renal dysfunction.
- •Hematological Disorders: Coagulation disorders or active bleeding diathesis.
- •Neurological/Cognitive Status: Presence of dementia, cognitive impairment, or inability to cooperate during the procedure.
- •Local Contraindications: Active infection at the site of the regional anesthesia intervention or surgical field.
- •Patient Refusal: Patients who declined regional anesthesia or had a known allergy to local anesthetics.
研究组 & 干预措施
GROUP SPINAL
干预措施: Spinal anesthesia (heavy bupivacaine) (Procedure)
Group SIFIB
干预措施: SUPRAINGUINAL FACIA ILIACA BLOCK (Procedure)
结局指标
主要结局
QUALITY OF RECOVERY- 40
时间窗: FIRST DAY AFTER SURGERY
PATIENTS WERE ASKED TO COMPLETE THE QUALITY OF RECOVERY- 40 QUESTIONNAIRE PREOPERATIVELY AND AT 24 HOURS POSTOPERATIVELY.
Quality of Recovery-40 (QoR-40)
时间窗: FIRST DAY AFTER SURGERY
Patients were asked to complete the Quality of Recovery-40 (QoR-40) questionnaire preoperatively and at 24 hours postoperatively. The QoR-40 score ranges from 40 to 200, with higher scores indicating better quality of recovery.
次要结局
- PLETH INDEKS(PREOPERATIVE VE INTRAOPERATIVE EVERY 10 MINUTES)
- PAIN SCORES(Measurements were taken at postoperative hours 0,2,4,6,12 and 24)
- Pleth Index(The Pleth Index was measured preoperatively and every 10 minutes during the intraoperative period.)
- Pain Scores(Measurements were taken at postoperative hours 0,2,4,6,12 and 24. The NRS score ranges from 0 to 10, with higher scores indicating more severe pain)
研究者
Fatma Dere
MD, Anesthesiologist
Zonguldak Bulent Ecevit University