Effect of stellate ganglion block on the prevention of posttraumatic stress disorder in patients undergoing emergency ocular trauma surgery: protocol for a randomized, double-blind, placebo-controlled trial

Background Post-traumatic stress disorder (PTSD) is a prevalent and debilitating mental health condition that often develops after exposure to traumatic events. Stellate ganglion block (SGB) has been shown to alleviate PTSD symptoms, suggesting its potential as a preventive intervention, particularly in patients undergoing emergency ocular trauma surgery. However, the efficacy of SGB in preventing the onset of PTSD has not been clearly established. Methods This dual-center, randomized, double-blind, placebo-controlled trial will enroll 300 adult patients undergoing emergency ocular trauma surgery. Participants will be randomly assigned, in a 1:1 ratio and stratified by age (<65 or ≥65 years), to either the SGB group or the placebo group ( n = 150 per group). Each participant will receive either an active right stellate ganglion block or a sham procedure administered 15 min prior to the induction of anesthesia. The primary outcome is the difference in the incidence of PTSD at 1 month after surgery. Secondary outcomes include the severity of PTSD, delayed-onset PTSD, the four core symptom clusters (intrusive re-experiencing, avoidance, negative alterations in cognition or mood, and hyperarousal and reactivity), the severity of dissociative symptoms, Beck Anxiety Inventory (BAI) scores at 24, 48, and 72 h postoperatively; Visual Analog Scale (VAS) sleep scores at 24, 48, and 72 h postoperatively; Numerical Rating Scale (NRS) pain scores at 24, 48, and 72 h postoperatively; Heart Rate Variability (HRV) measured intraoperatively and at 24 and 48 h postoperatively; recovery time; extubation time; Richmond Agitation-Sedation Scale (RASS) scores; and length of hospital stay. Safety outcomes will include neck pain, dizziness, tinnitus, respiratory depression, anaphylaxis, sinus bradycardia (defined as heart rate <50 beats/min), hematoma formation, infection, severe arrhythmia, pneumothorax, and complications related to general or spinal anesthesia. All data will be analyzed using a modified intention-to-treat (mITT) approach. Discussion This study aims to evaluate the efficacy and safety of SGB for the prevention of PTSD in patients undergoing emergency ocular trauma surgery. Clinical trial registration ChiCTR2500102717, www.chictr.org.cn/showproj.html?proj=270046 .