Effect of Paresthesia During Interscalene Block Procedure on the Incidence of Postoperative Neurological Symptoms: A Prospective Observational Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Paresthesia incidence
研究概览
简要总结
In this study, the effect of paresthesia occurring during the interscalene block procedure on the incidence of postoperative neurological symptoms will be investigated. Paresthesia is defined as an abnormal sensation described as "tingling, pinprick, severe pain, or an electric feeling in the arm." The status of postoperative neurological symptoms in patients at the end of the block's effective duration will be assessed through phone interviews, evaluating symptoms such as arm numbness, tingling, abnormal sensations, pain, and weakness.
详细描述
Our study includes patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I or II who undergo interscalene nerve block prior to arthroscopic shoulder surgery under general anesthesia. All patients will be fasting according to standard protocol. During the preoperative period, patients' age, comorbidities, gender, body mass index (BMI), ASA scores, and preoperative Quality of Recovery-15 (QoR-15) scores will be recorded.
In the operating room, possible complications related to the block (paresthesia, Horner's syndrome, dyspnea, hoarseness) will be monitored in the preoperative area. During the intraoperative period, data such as pulse, blood pressure, infusion fluids, intraoperative remifentanil requirements, anesthesia duration, and surgical time will be recorded.
In the postoperative period, postoperative pain status, block duration, postoperative nausea and vomiting, need for rescue analgesics and antiemetics, and QoR-15 scores on the first day will be assessed in the recovery room and ward. Additionally, postoperative neurological symptoms and QoR-15 scores will be followed via telephone on the 3rd, 7th, 10th, and 30th days after discharge.
For patients developing postoperative pain, pain intensity will be evaluated using an 11-point numeric rating scale, where 0 indicates no symptoms and 10 represents maximum severity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •ASA physical status I to II
- •Age range of 18-65 years
- •Patients planned for interscalene nerve block for analgesia prior to arthroscopic shoulder surgery in the beach chair position under general anesthesia
排除标准
- •body mass index >35 kg/m²)
- •history of drug use
- •Patient's refusal to participate in the study
- •Psychiatric disorders
- •Central nervous system diseases
- •Vestibular disorders
- •Presence of diabetes, neuropathy, and paralysis
- •Pregnancy
- •Open shoulder surgery
- •Allergy to local anesthetics
- •Coagulopathy
- •Severe thrombocytopenia
- •Infection at the puncture site
- •Pre-existing neuropathy in the limb to be operated on
- •Use of opioid and antiemetic medications before surgery
- •Use of dexamethasone
- •Lung disease
- •Low baseline oxygen saturation
- •Patients who cannot cooperate in the postoperative period (e.g., mental retardation, delirium, language acquisition deficiency, etc.)
结局指标
主要结局
Paresthesia incidence
时间窗: Perioperative time
Paresthesia is considered an abnormal sensation described as "tingling, pinprick, severe pain, or an electric feeling in the arm." When paresthesia occurs, the block procedure will be halted, and the needle will be redirected; local anesthetic will not be administered until the paresthesia resolves, and the occurrence of paresthesia will be recorded.
次要结局
- Incidence of postoperative neurological symptoms(30 days)
- Postoperative nausea and vomiting(36 hours)
- Rescue analgesic requirement(36 hours)
- Duration of stay in the recovery room(2 hours)
- Quality of Recovery-15 (QoR-15) scores(30 days)
- Horner's syndrome(Perioperative/Periprocedural)
- Postoperative pain(36 hours)
- intraoperative opioid requirement(intraoperative time)
- Duration of block effectiveness(36 hours)
- Rescue antiemetic requirement(36 hours)
- Dyspnea(Perioperative/Periprocedural)
- Hoarseness(Perioperative/Periprocedural)
研究者
Gökhan Erdem
Anesthesiology and Reanimation specialist doctor
Ankara City Hospital Bilkent