Yu Y, Li Y, Han D, et al. Effect of perioperative polarised light stellate ganglion irradiation on postoperative stress disorder in emergency trauma patients: protocol for a randomised controlled trial. BMJ Open. 2025;15(10):e096056.
Keywords: Adult psychiatry; Pain management; Physical Therapy Modalities; Randomized Controlled Trial.
Abstract
Background: The hyperactivity of the sympathetic nervous system after a traumatic event contributes to the development of post-traumatic stress disorder (PTSD). Polarised light stellate ganglion irradiation (PLSGI) is a non-invasive and effective physiotherapy method for regulating the sympathetic nervous system. This study aims to investigate the effects of perioperative PLSGI on PTSD and pain-related outcomes in patients undergoing emergency surgery.
Methods and analysis: This multicentre, randomised, double-blind, controlled trial will include 510 adult patients scheduled for emergency trauma surgery. Patients will be randomly assigned in a 1:1 ratio, stratified by anaesthesia type (propofol general anaesthesia or other anaesthesia), to either the PLSGI group or the control group. The PLSGI group will receive perioperative PLSGI, while the control group will receive a sham PLSGI procedure. All patients will receive multimodal analgesia, consisting of intraoperative flurbiprofen axetil, ropivacaine infiltration at the end of surgery and postoperative patient-controlled sufentanil. The primary outcome is the incidence of PTSD 1 month postoperatively. Secondary outcomes include the severity of PTSD, delayed-onset PTSD, four symptom clusters (intrusive re-experiencing symptoms, avoidance symptoms, negative alterations in cognition or mood symptoms, and hyperarousal and reactivity symptoms), severity of dissociative symptoms, the amount of emergency postoperative analgesia, heart rate variability, sleep quality, anxiety, chronic pain, postoperative opioid use (sufentanil consumption) and need for rescue analgesia. Safety outcomes include hypotension, bradycardia, hypertension, tachycardia, interventions for haemodynamic events, malignant arrhythmias, hoarseness, localised allergy or burning pain, dyspnoea and coughing while drinking. All analyses will be conducted in the modified intention-to-treat population.
Ethics and dissemination: Ethical approval was obtained from the Ethics Committee of Xuzhou Central Hospital (XZXY-LK-20210129-2023040), the Ethics Committee of Suzhou Xiangcheng People's Hospital (2023-KY-02) and the Ethics Committee of Xuzhou Renci Hospital (XZRCLL-KT-202302001). All patients will provide written informed consent. The results of this study will be published in a peer-reviewed journal.