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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cangzhou Central Hospital | Cangzhou | Hebei | 061001 | China |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Parallel assignment with two arms (ultrasound-guided right-sided stellate ganglion block plus standardized general anesthesia vs sham saline injection plus standardized general anesthesia).
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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.
|
| 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. |
|
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 |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |