Evaluation of Irisin Levels in Adult Patients With Forearm Fractures Undergoing Surgery With Infraclavicular Block and General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Change in Serum Irisin Levels
研究概览
简要总结
This randomized prospective study evaluates the effect of general anesthesia versus infraclavicular nerve block on perioperative serum irisin levels in adults undergoing forearm fracture surgery. Irisin levels will be measured preoperatively, at 30 minutes postoperatively, and at 24 hours postoperatively. The association between irisin changes and fracture healing will be explored as a secondary outcome.
详细描述
Forearm fractures are common injuries in adults and frequently require surgical intervention due to instability and displacement. Postoperative recovery quality and fracture healing are influenced by multiple factors, including the type of anesthesia administered during surgery. However, the biochemical and metabolic effects of different anesthesia techniques on bone healing remain insufficiently explored.
Irisin is a myokine derived from the cleavage of fibronectin type III domain-containing protein 5 (FNDC5) and plays a significant role in muscle-bone crosstalk. Experimental and clinical studies have demonstrated that irisin promotes osteoblast differentiation, inhibits osteocyte apoptosis, and contributes to bone homeostasis and fracture healing. Despite its potential importance, the relationship between anesthesia techniques and perioperative irisin levels has not been previously investigated.
This single-center, randomized, prospective clinical trial aims to compare the effects of general anesthesia and infraclavicular brachial plexus block on perioperative serum irisin levels in adult patients undergoing elective forearm fracture surgery. Patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-III will be randomly assigned to one of two groups: general anesthesia (Group G) or infraclavicular block (Group B).
Serum irisin levels will be measured at three time points: preoperatively, 30 minutes postoperatively, and 24 hours postoperatively. In addition to biochemical outcomes, intraoperative hemodynamic parameters (heart rate, blood pressure, oxygen saturation), analgesic consumption, and demographic data will be recorded. Postoperative radiographs will be evaluated to monitor fracture healing and callus formation, which will be analyzed as a secondary outcome in relation to changes in irisin levels.
The primary outcome of the study is the comparison of perioperative changes in serum irisin levels between the two anesthesia techniques. Secondary outcomes include the relationship between irisin level changes and radiological fracture healing, as well as differences in perioperative physiological stress responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Adults aged 18 to 65 years
- •Scheduled for elective forearm fracture surgery
- •Planned to receive either general anesthesia or infraclavicular brachial plexus block
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Able to provide written and verbal informed consent
排除标准
- •Age <18 years or >65 years
- •Emergency surgery
- •Refusal or inability to provide informed consent
- •ASA physical status IV or V
- •Known bone diseases or metabolic bone disorders
- •Multiple trauma or associated organ injury
- •Inability to mobilize
- •Morbid obesity (BMI >40 kg/m²)
- •Renal failure
- •Hepatic failure
- •Neurological deficits or sequelae
- •Contraindication or allergy to any anesthetic agents used in the study
研究组 & 干预措施
General Anesthesia (GA) Group
Adult patients undergoing elective forearm fracture surgery under general anesthesia. Standard noninvasive monitoring will be used and perioperative hemodynamic variables and analgesic use will be recorded. Blood samples for serum irisin will be collected preoperatively, at 30 minutes postoperatively, and at 24 hours postoperatively.
干预措施: General Anesthesia (GA) (Procedure)
Infraclavicular Block (ICB) Group
Adult patients undergoing elective forearm fracture surgery with an ultrasound-guided infraclavicular brachial plexus block performed approximately 1 hour before surgery under monitored conditions. Standard noninvasive monitoring will be used; perioperative hemodynamic variables and analgesic use will be recorded. Blood samples for serum irisin will be collected preoperatively, at 30 minutes postoperatively, and at 24 hours postoperatively.
干预措施: Infraclavicular Brachial Plexus Blocks (Procedure)
结局指标
主要结局
Change in Serum Irisin Levels
时间窗: Preoperative (baseline), 30 minutes postoperatively, and 24 hours postoperatively
Serum irisin levels (ng/dL) will be measured to evaluate the effect of anesthesia type on perioperative irisin response. Blood samples will be collected at three time points: preoperatively (baseline), 30 minutes postoperatively, and 24 hours postoperatively. Changes in irisin levels will be compared between the general anesthesia group and the infraclavicular block group.
次要结局
- Radiological Fracture Healing and Callus Formation(Postoperative follow-up period (up to 6 months))