Impact of Anesthesia Method on Surgical View and Surgeon Satisfaction During Shoulder Arthroscopy: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Surgical View Clarity Score
研究概览
简要总结
This prospective observational study evaluates the effect of the anesthesia method (general anesthesia versus regional anesthesia [interscalene nerve block/superficial cervical block] with sedation) on the operating clarity of the surgical view and the surgeon's satisfaction during elective shoulder arthroscopy. The study investigates how these different anesthesia techniques influence intraoperative conditions, specifically bleeding amounts and the visibility of the surgical field, which are critical for the success of this minimally invasive procedure. Additionally, the research will monitor patient-centered outcomes, including postoperative pain levels, recovery time, and potential side effects such as nausea or vomiting, to determine which anesthesia strategy provides the optimal balance of surgical efficiency and patient comfort.
详细描述
Shoulder arthroscopy is a minimally invasive surgical procedure where the clarity of the surgeon's visual field is critical for technical success and operative efficiency. The quality of the intraoperative view is heavily influenced by perioperative variables, particularly intraoperative bleeding and hemodynamic stability. Consequently, the anesthetic management strategy-whether General Anesthesia (GA) or Regional Anesthesia (RA) [interscalene nerve block/superficial cervical block] combined with sedation-may significantly alter these conditions. This study aims to prospectively evaluate and compare how these two distinct anesthesia methods impact the clarity of the surgical field, and the operating surgeon's satisfaction.
This is a prospective, observational cohort study will conducted at the Sabuncuoğlu Serefeddin Training and Research Hospital. The study utilizes a naturalistic, non-randomized design. There is no interference with the choice of anesthesia; group assignment is determined solely by routine clinical decision-making and patient preference during the preoperative assessment. Patients are recruited and observationally assigned to one of two cohorts based on the technique administered:
- General Anesthesia Group: Patients who elect or are clinically selected to receive general anesthesia.
- Regional Anesthesia Group: Patients who elect or are clinically selected to receive an interscalene nerve block/superficial cervical block combined with sedation.
Intraoperative physiological variables, including heart rate, systolic and diastolic blood pressure, oxygen saturation, and respiratory rate, will be continuously monitored throughout the procedure. The study will also record the feasibility of implementing controlled hypotension and analyze its correlation with intraoperative bleeding amounts. To provide a holistic comparison between anesthesia methods, the study will track postoperative recovery metrics, including the total duration of surgery and anesthesia. Additionally, postoperative pain will be assessed using the Numeric Rating Scale (NRS) at 1, 2, 4, 8, 16, and 24 hours post-procedure. The incidence of opioid-related side effects, such as nausea and vomiting, will be monitored and recorded during the postoperative period .
Primary Assessment:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteers aged 18 to 75 years.
- •Patients scheduled for elective shoulder arthroscopy.
- •Patients with an ASA (American Society of Anesthesiologists) physical status score of I, II, or III.
- •Patients capable of providing informed consent.
排除标准
- •Previous surgical procedure performed on the same shoulder.
- •Presence of medical contraindications that could affect the choice of anesthesia (coagulopathy, active infection, severe pulmonary diseases)
- •Known allergy to local anesthetics or general anesthesia agents
- •History of opioid dependence or chronic pain syndrome
- •Presence of neurological disorders, particularly those involving the brachial plexus
研究组 & 干预措施
General Anesthesia Group
Patients undergoing elective shoulder arthroscopy who receive general anesthesia as determined by routine clinical practice and patient preference.
Regional Anesthesia Group
Patients undergoing elective shoulder arthroscopy who receive regional anesthesia [interscalene nerve block/superficial cervical block] combined with sedation as determined by routine clinical practice and patient preference.
结局指标
主要结局
Surgical View Clarity Score
时间窗: Intraoperative (assessed immediately upon completion of wound closure)
The clarity of the surgical field and the extent to which bleeding obscures visualization are evaluated by the surgeon using a 5-point Likert scale. The scale ranges from 1 (Poor/No Visualization) to 5 (Excellent/Crystal Clear Visualization).
次要结局
- Surgeon Satisfaction Score(Intraoperative (assessed immediately upon completion of wound closure))
- Intraarticular Bleeding Severity(Intraoperative)
- Feasibility of Controlled Hypotension(Intraoperative)
- Duration of Surgery(Intraoperative)
- Duration of Anesthesia(Intraoperative)
- Postoperative Pain Score (NRS)(Postoperative hours 1, 2, 4, 8, 16, and 24)
- Incidence of Opioid-Related Side Effects(Postoperative 24 hours)
- Patient Satisfaction Score(Postoperative 24 hours)
研究者
Harun Tolga Duran
Medical Doctor
Amasya University