Ultrasound-Guided Stellate Ganglion Block Combined With Propofol for Perimenopausal Insomnia With Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 233
- 试验地点
- 1
- 主要终点
- Mean Arterial Pressure During Airway Manipulation
研究概览
简要总结
Laparoscopic myomectomy is a commonly performed minimally invasive gynecologic procedure. However, surgical trauma, tracheal intubation, and pneumoperitoneum may induce pronounced perioperative stress responses, resulting in hemodynamic instability, postoperative pain, inflammatory activation, sleep disturbance, and anxiety, which can delay postoperative recovery.
Stellate ganglion block (SGB) is a sympathetic nerve modulation technique that has been shown to attenuate stress-related sympathetic overactivity. This study aimed to evaluate the clinical effects and safety of ultrasound-guided right-sided stellate ganglion block combined with standardized general anesthesia in patients undergoing laparoscopic myomectomy.
In this randomized controlled study, a total of 240 patients scheduled for laparoscopic myomectomy were randomly assigned to either a combined block group (ultrasound-guided right-sided SGB before anesthesia induction plus general anesthesia) or a general anesthesia group (sham saline injection plus general anesthesia). Perioperative hemodynamic parameters, heart rate variability, postoperative pain scores, analgesic requirements, recovery profiles, inflammatory stress markers, sleep quality, anxiety levels, and adverse events were compared between groups.
This study was retrospectively registered after completion. The results are intended to provide evidence for optimizing perioperative management and enhancing recovery in patients undergoing laparoscopic myomectomy.
详细描述
This single-center, randomized controlled clinical study was conducted to investigate the effects of ultrasound-guided right-sided stellate ganglion block (SGB) on perioperative stress responses and postoperative recovery in patients undergoing laparoscopic myomectomy under general anesthesia.
A total of 240 adult female patients scheduled for elective laparoscopic myomectomy were enrolled and randomly assigned in a 1:1 ratio to either the combined block group or the general anesthesia group. All participants received standardized general anesthesia with propofol-based induction and maintenance. In the combined block group, ultrasound-guided right-sided stellate ganglion block was performed prior to anesthesia induction using ropivacaine. In the control group, an identical ultrasound-guided procedure was conducted with injection of an equal volume of normal saline at the same anatomical location.
Perioperative management and postoperative analgesia protocols were standardized for both groups. Hemodynamic variables and heart rate variability parameters were recorded at predefined perioperative time points. Postoperative pain intensity was assessed using the visual analog scale, and analgesic consumption was recorded during the first 48 hours after surgery. Recovery indicators, including time to first flatus and ambulation, were documented. Inflammatory and stress-related biomarkers were measured preoperatively and at 24 hours postoperatively. Sleep quality and anxiety were evaluated using validated questionnaires before surgery and on postoperative day one. Adverse events were monitored and recorded throughout the perioperative period.
The study protocol was reviewed and approved by the Ethics Committee of Cangzhou Central Hospital (Approval No. 2024-332-03). Written informed consent was obtained from all participants prior to enrollment. The trial was retrospectively registered following study completion to enhance transparency and public accessibility of the study design and results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors were blinded to group allocation. The anesthesiologist performing the stellate ganglion block was not blinded due to the nature of the intervention.
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 35 to 55 years.
- •Diagnosed with uterine fibroids and scheduled for elective laparoscopic myomectomy.
- •American Society of Anesthesiologists (ASA) physical status classification I or II.
- •Normal cognitive function and ability to understand the study procedures.
- •Provided written informed consent prior to participation.
排除标准
- •Contraindications to stellate ganglion block, including coagulation disorders, infection at the puncture site, or allergy to local anesthetics.
- •Severe dysfunction of major organs, including heart, liver, or kidney.
- •Poorly controlled chronic diseases such as hypertension or diabetes mellitus.
- •History of psychiatric disorders, chronic pain conditions, or long-term use of sedatives, analgesics, or medications affecting autonomic nervous system function.
- •Preexisting significant sleep disorders prior to surgery.
- •Abnormal cervical anatomy, history of cervical surgery, or radiotherapy.
- •Anticipated difficult airway.
- •Conversion to open surgery during the procedure.
- •Failure of stellate ganglion block.
- •Occurrence of serious adverse events related to the block procedure, such as nerve injury, arrhythmia, or local anesthetic systemic toxicity.
- •Unplanned admission to the intensive care unit after surgery.
研究组 & 干预措施
Combined Block Group
Patients received ultrasound-guided right-sided stellate ganglion block prior to anesthesia induction, followed by standardized general anesthesia for laparoscopic myomectomy.
干预措施: Ultrasound-Guided Stellate Ganglion Block (Procedure)
General Anesthesia Group
Patients received an ultrasound-guided sham injection with an equal volume of normal saline at the stellate ganglion prior to anesthesia induction, followed by standardized general anesthesia for laparoscopic myomectomy.
干预措施: Sham Stellate Ganglion Block (Procedure)
结局指标
主要结局
Mean Arterial Pressure During Airway Manipulation
时间窗: Immediately after tracheal intubation and at extubation during surgery
Mean arterial pressure (MAP), measured in mmHg.
Heart Rate During Airway Manipulation
时间窗: Immediately after tracheal intubation and at extubation during surgery
Heart rate (HR), measured in beats per minute.
次要结局
- Low-Frequency (LF) Power of Heart Rate Variability(Pre-block (baseline), immediately after tracheal intubation, 5 minutes after pneumoperitoneum creation, at the end of surgery, and at extubation)
- Low-Frequency/High-Frequency (LF/HF) Ratio of Heart Rate Variability(Pre-block (baseline), immediately after tracheal intubation, 5 minutes after pneumoperitoneum creation, at the end of surgery, and at extubation)
- Postoperative Pain Intensity at Rest(6 hours, 12 hours, and 24 hours after surgery)
- Postoperative Patient-Controlled Intravenous Analgesia (PCIA) Use(Within 48 hours after surgery)
- Use of Rescue Analgesia(Within 48 hours after surgery)
- Time to First Flatus(From end of surgery to first postoperative flatus (assessed up to hospital discharge, up to 7 days))
- Time to First Ambulation(From end of surgery to first postoperative ambulation (assessed up to hospital discharge, up to 7 days))
- Length of Hospital Stay(From completion of surgery to hospital discharge (up to 7 days))
- Serum Interleukin-6 Level(Baseline (pre-intervention) and 24 hours after surgery)
- Serum Cortisol Level(Baseline (pre-intervention) and 24 hours after surgery)
- Serum Norepinephrine Level(Baseline (pre-intervention) and 24 hours after surgery)
- Sleep Quality(Preoperatively and postoperative day 1)
- Anxiety Level(Preoperatively and postoperative day 1)
- Adverse Events(Within 48 hours after surgery)
研究者
Xiaochen Ji
Principal Investigator
Cangzhou Central Hospital