Ultrasound-Guided Stellate Ganglion Block Plus Propofol for Perimenopausal Insomnia With Anxiety (SGB-PROP-PIA)

Ultrasound-Guided Stellate Ganglion Block Combined With Propofol for Perimenopausal Insomnia With Anxiety

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.

Study Overview

• Status: Completed
• Conditions: Uterine Fibroids (UF)
• Intervention / Treatment: Procedure: Ultrasound-Guided Stellate Ganglion Block; Procedure: Sham Stellate Ganglion Block

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 233
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Cangzhou, Hebei, China, 061001
      • Cangzhou Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined Block Group; Patients received ultrasound-guided right-sided stellate ganglion block prior to anesthesia induction, followed by standardized general anesthesia for laparoscopic myomectomy.	Procedure: Ultrasound-Guided Stellate Ganglion Block; Ultrasound-guided right-sided stellate ganglion block was performed prior to anesthesia induction. Using a high-frequency linear ultrasound probe at the C6 level, ropivacaine was injected into the prevertebral fascial plane between the longus colli muscle and prevertebral fascia.
Sham Comparator: 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.	Procedure: Sham Stellate Ganglion Block; An ultrasound-guided sham procedure was performed prior to anesthesia induction, in which an equal volume of normal saline was injected at the same anatomical location without performing an active stellate ganglion block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Arterial Pressure During Airway Manipulation	Mean arterial pressure (MAP), measured in mmHg.	Immediately after tracheal intubation and at extubation during surgery
Heart Rate During Airway Manipulation	Heart rate (HR), measured in beats per minute.	Immediately after tracheal intubation and at extubation during surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low-Frequency (LF) Power of Heart Rate Variability	Low-frequency (LF) power of heart rate variability, measured in ms²/Hz.	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	Low-frequency to 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	Pain intensity assessed using the Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating more severe pain.	6 hours, 12 hours, and 24 hours after surgery
Postoperative Patient-Controlled Intravenous Analgesia (PCIA) Use	Number of patient-controlled intravenous analgesia (PCIA) pump button presses.	Within 48 hours after surgery
Use of Rescue Analgesia	Proportion of participants receiving rescue analgesia.	Within 48 hours after surgery
Time to First Flatus	Time from completion of surgery to first postoperative flatus, measured in hours.	From end of surgery to first postoperative flatus (assessed up to hospital discharge, up to 7 days)
Time to First Ambulation	Time from completion of surgery to first postoperative ambulation, measured in hours.	From end of surgery to first postoperative ambulation (assessed up to hospital discharge, up to 7 days)
Length of Hospital Stay	Total length of postoperative hospital stay, measured in days.	From completion of surgery to hospital discharge (up to 7 days)
Serum Interleukin-6 Level	Serum interleukin-6 (IL-6) concentration.	Baseline (pre-intervention) and 24 hours after surgery
Serum Cortisol Level	Serum cortisol concentration.	Baseline (pre-intervention) and 24 hours after surgery
Serum Norepinephrine Level	Serum norepinephrine concentration.	Baseline (pre-intervention) and 24 hours after surgery
Sleep Quality	Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI), with total scores ranging from 0 to 21, where higher scores indicate poorer sleep quality.	Preoperatively and postoperative day 1
Anxiety Level	Anxiety assessed using the Self-Rating Anxiety Scale (SAS), with standard scores ranging from 20 to 80, where higher scores indicate greater anxiety severity.	Preoperatively and postoperative day 1
Adverse Events	Incidence of postoperative adverse events, including nausea and vomiting, dizziness, headache, and shoulder pain.	Within 48 hours after surgery

Collaborators and Investigators

• Sponsor: Xiaochen Ji

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: January 18, 2026
• First Submitted That Met QC Criteria: January 31, 2026
• First Posted (Actual): February 3, 2026

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 31, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Pain; Heart Rate Variability; General Anesthesia; Perioperative Stress Response; Postoperative Recovery; Stellate Ganglion Block; Laparoscopic Myomectomy; Perioperative Hemodynamics
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Muscle Tissue; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Leiomyoma
• Other Study ID Numbers: CZCH-SGB-PROP-INS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No