Uterine Fibroids (UF)SGB-PROP-PIANCT07384468
Ultrasound-Guided Stellate Ganglion Block Plus Propofol for Perimenopausal Insomnia With Anxiety
A study testing Ultrasound-Guided Stellate Ganglion Block in people with Uterine Fibroids (UF), run by Xiaochen Ji at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 55 years, women only
- Conditions the study is for
- Uterine Fibroids (UF)
- What is being tested?
- Ultrasound-Guided Stellate Ganglion Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 233 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Uterine Fibroids (UF)
- Being tested
- Ultrasound-Guided Stellate Ganglion Block, Sham Stellate Ganglion Block
- Keywords
- Stellate Ganglion Block, Laparoscopic Myomectomy, General Anesthesia, Perioperative Hemodynamics, Heart Rate Variability, Postoperative Recovery, Perioperative Stress Response, Postoperative Pain
- Medical subject headings
- Leiomyoma, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Stellate Ganglion BlockProcedure or surgery
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 Stellate Ganglion BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Sham Stellate Ganglion Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Arterial Pressure During Airway Manipulation
Mean arterial pressure (MAP), measured in mmHg.
Measured: Immediately after tracheal intubation and at extubation during surgery
Heart Rate During Airway Manipulation
Heart rate (HR), measured in beats per minute.
Measured: Immediately after tracheal intubation and at extubation during surgery
Secondary outcomes (14)
Low-Frequency (LF) Power of Heart Rate Variability
Low-frequency (LF) power of heart rate variability, measured in ms²/Hz.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 48 hours after surgery
Use of Rescue Analgesia
Proportion of participants receiving rescue analgesia.
Measured: Within 48 hours after surgery
Time to First Flatus
Time from completion of surgery to first postoperative flatus, measured in hours.
Measured: 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.
Measured: 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.
Measured: From completion of surgery to hospital discharge (up to 7 days)
Serum Interleukin-6 Level
Serum interleukin-6 (IL-6) concentration.
Measured: Baseline (pre-intervention) and 24 hours after surgery
Serum Cortisol Level
Serum cortisol concentration.
Measured: Baseline (pre-intervention) and 24 hours after surgery
Serum Norepinephrine Level
Serum norepinephrine concentration.
Measured: 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.
Measured: 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.
Measured: Preoperatively and postoperative day 1
Adverse Events
Incidence of postoperative adverse events, including nausea and vomiting, dizziness, headache, and shoulder pain.
Measured: Within 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 May 2022
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Fibroids (UF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment with two arms (ultrasound-guided right-sided stellate ganglion block plus standardized general anesthesia vs sham saline injection plus standardized general anesthesia).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiaochen Ji
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaochen Ji, Cangzhou Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384468
- Sponsor's protocol ID
- CZCH-SGB-PROP-INS-01
- Acronym
- SGB-PROP-PIA
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Stellate Ganglion Block Combined With Propofol for Perimenopausal Insomnia With Anxiety
- ClinicalTrials.gov ID
- NCT07384468
- Acronym / sponsor ID
- SGB-PROP-PIA / CZCH-SGB-PROP-INS-01
- Conditions
- Uterine Fibroids (UF)
- Keywords
- Stellate Ganglion Block, Laparoscopic Myomectomy, General Anesthesia, Perioperative Hemodynamics, Heart Rate Variability, Postoperative Recovery, Perioperative Stress Response, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Xiaochen JiUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment with two arms (ultrasound-guided right-sided stellate ganglion block plus standardized general anesthesia vs sham saline injection plus standardized general anesthesia).
| Arm | Type | Receives |
|---|---|---|
| Combined Block Group | Experimental | Procedure: Ultrasound-Guided Stellate Ganglion BlockPatients received ultrasound-guided right-sided stellate ganglion block prior to anesthesia induction, followed by standardized general anesthesia for laparoscopic myomectomy. |
| General Anesthesia Group | Sham comparator | Procedure: Sham Stellate Ganglion BlockPatients 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. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-Guided Stellate Ganglion BlockUltrasound-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. | Procedure or surgery | Combined Block Group |
| Sham Stellate Ganglion BlockAn 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. | Procedure or surgery | General Anesthesia Group |
Primary outcome
Mean Arterial Pressure During Airway Manipulation
Time frame: Immediately after tracheal intubation and at extubation during surgery
Mean arterial pressure (MAP), measured in mmHg.
Heart Rate During Airway Manipulation
Time frame: Immediately after tracheal intubation and at extubation during surgery
Heart rate (HR), measured in beats per minute.
14 secondary outcomes
Low-Frequency (LF) Power of Heart Rate Variability
Time frame: 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
Time frame: 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
Time frame: 6 hours, 12 hours, and 24 hours after surgery
Postoperative Patient-Controlled Intravenous Analgesia (PCIA) Use
Time frame: Within 48 hours after surgery
Use of Rescue Analgesia
Time frame: Within 48 hours after surgery
Time to First Flatus
Time frame: From end of surgery to first postoperative flatus (assessed up to hospital discharge, up to 7 days)
Time to First Ambulation
Time frame: From end of surgery to first postoperative ambulation (assessed up to hospital discharge, up to 7 days)
Length of Hospital Stay
Time frame: From completion of surgery to hospital discharge (up to 7 days)
Serum Interleukin-6 Level
Time frame: Baseline (pre-intervention) and 24 hours after surgery
Serum Cortisol Level
Time frame: Baseline (pre-intervention) and 24 hours after surgery
Serum Norepinephrine Level
Time frame: Baseline (pre-intervention) and 24 hours after surgery
Sleep Quality
Time frame: Preoperatively and postoperative day 1
Anxiety Level
Time frame: Preoperatively and postoperative day 1
Adverse Events
Time frame: Within 48 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Stellate Ganglion Block in people with Uterine Fibroids (UF), run by Xiaochen Ji at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Arterial Pressure During Airway Manipulation (time frame: Immediately after tracheal intubation and at extubation during surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.