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A single-center, randomized, controlled, feasibility pilot study of ultrasound-guided stellate ganglion block for post-traumatic stress disorder symptoms in patients undergoing surgery for gastrointestinal malignancies

Effects of ultrasound-guided stellate ganglion block on post-traumatic stress disorder symptoms in patients undergoing surgery for gastrointestinal malignancies: a single-center, Phase I pilot feasibility study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110344
Enrollment
Unknown
Registered
2025-10-13
Start date
2025-10-15
Completion date
Unknown
Last updated
2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-traumatic stress disorder (PTSD)

Interventions

Intervention group (SGB):Ultrasound-guided right stellate ganglion block with 7-10 mL 0.5% ropivacaine
Control group (sham SGB):simulate full procedure before induction
needle tip stops at subcutaneous layer (superficial to deep cervical fascia), avoiding longus colli fascia
inject 1–2 mL 0.9% saline (preservative-free).

Sponsors

The First Affiliated Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed GI malignancy (stage I–III), age 18–75 yrs, KPS>=70, scheduled for elective surgery; 2. CAPS-5 total score=23 (moderate or greater PTSD symptoms); 3. Psychiatric medication stable=3 months if applicable; 4. Able to use electronic follow-up devices; 5. Signed informed consent, voluntary participation.

Exclusion criteria

Exclusion criteria: 1. Refusal to participate; 2. Allergy to amide local anesthetics; 3. Pregnancy or lactation; 4. SGB contraindications: coagulopathy, local infection, severe COPD, acute MI, glaucoma, etc.; 5. Anatomical abnormalities: cervical deformity, prior neck surgery/trauma, tumor involvement near SG; 6. Undergoing SGB; 7. Previous SGB without response; 8. Schizophrenia or other severe psychiatric disorders; 9. Moderate-to-severe traumatic brain injury; 10. Moderate-to-severe substance use disorder within 30 days.

Design outcomes

Primary

MeasureTime frame
Recruitment completion rate;Intervention completion rate;12-week follow-up rate;Treatment-related SAE rate;—

Secondary

MeasureTime frame
Change in CAPS-5 Total Symptom Severity Score (TSSS);Response Rate (MCID);Remission Rate (Primary Definition);Group Differences in CAPS-5 TSSS;Depression (BDI-II);Anxiety (GAD-7);Quality of Life (WHOQOL-BREF);Sleep Quality (PSQI);Social Functioning (SASS);Remission Rate (Exploratory Threshold);Incidence of Horner’s sign;Incidence of all adverse events;—

Countries

China

Contacts

Public ContactQun Lin

The First Affiliated Hospital of Fujian Medical University

linqun008@163.com+86 138 5909 1369

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026