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

NCT07384468 | Completed

• 1 other identifier: CZCH-SGB-PROP-INS-01
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uterine Fibroids (UF)

Keywords

Stellate Ganglion Block; Laparoscopic Myomectomy; General Anesthesia; Perioperative Hemodynamics; Heart Rate Variability; Postoperative Recovery; Perioperative Stress Response; Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• 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

Study Arms (2)

Combined Block Group

EXPERIMENTAL

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

General Anesthesia Group

SHAM COMPARATOR

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

Interventions

Ultrasound-Guided Stellate Ganglion Block PROCEDURE

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.

Combined Block Group

Sham Stellate Ganglion Block PROCEDURE

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.

General Anesthesia Group

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiaochen Ji: lead

Study Sites (1)

Cangzhou Central Hospital

Cangzhou, Hebei, 061001, China

Location

MeSH Terms

Conditions

Leiomyoma; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel assignment with two arms (ultrasound-guided right-sided stellate ganglion block plus standardized general anesthesia vs sham saline injection plus standardized general anesthesia).

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: February 3, 2026
• Study Start: May 1, 2022
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)