CompletedNot Applicable

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

China233 participantsStarted 2022-05-01

Plain-language summary

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.

Who can participate

Age range

35 Years – 55 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Arterial Pressure During Airway Manipulation

Timeframe: Immediately after tracheal intubation and at extubation during surgery

Heart Rate During Airway Manipulation

Timeframe: Immediately after tracheal intubation and at extubation during surgery

Trial details

NCT IDNCT07384468

SponsorXiaochen Ji

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-31

View on ClinicalTrials.gov More Uterine Fibroids (UF) trials