transauricular auricular vagus nerve stimulation
DevicePatients will receive five taVNS sessions, with each session lasting 60 minutes.
NCT Number: NCT07330973
Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive, novel neuromodulation technique. Previous studies have demonstrated its safety and efficacy in chronic pain, mental disorders, and other diseases, but evidence regarding its use in acute postoperative pain remains limited. This project aims to explore the efficacy and safety of taVNS in managing acute pain after complex spinal surgery. This is a single-center, double-blind, randomized controlled clinical trial, planning to recruit 98 patients scheduled to undergo complex spinal surgery at the Second Affiliated Hospital of Zhejiang University School of Medicine. Participants will be randomly assigned to either the experimental group (taVNS stimulation) or the control group (sham stimulation). The experimental group will receive five stimulation sessions, each lasting one hour, from one day before surgery to three days after surgery. The primary outcome was opioid consumption within 72 hours postoperatively. Secondary outcomes included the maximum, minimum, and mean NRS on postoperative days 1, 2, and 3; NRS before and after each taVNS stimulation; time to first PCIA compression and number of PCA sessions within 3 days postoperatively; Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSQI), and Quality of Recovery Scale (QoR15) on postoperative day 3; time to first flatus, and first bowel movement; and the incidence of chronic pain, HADS, PSQI, and QoR15 at 3 months postoperatively.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive five taVNS sessions, with each session lasting 60 minutes.
Time frame: Within 72 hours postoperatively
Researchers will record the dosage of opioids used by participants within 72 hours after surgery and convert it into morphine equivalents.
Time frame: within 72 hours postoperatively
Maximum, minimum, and mean NRS on postoperative days 1, 2, and 3, and NRS before and after taVNS stimulation.
Time frame: Within 72 hours postoperatively
Including the first compression time of PCA and times of PCA within 72 hours postoperatively
Time frame: on the 3 months
Assessed by HADS within 3 months postoperatively
Time frame: on the 3 months
assessed by PSQI within 3 months postoperatively
Time frame: on the 3 months
Assessed by QoR15 within 3 months postoperatively
Time frame: at 3 months postoperatively
Assessed by NRS at 3 months postoperatively
Time frame: up to 2 weeks
Including time to first flatus and time to first bowel movement
Time frame: up to 1 month
Time frame: on the 3 months
Contact information is provided by the study sponsor or research team.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Pain in Patients Undergoing Complex Spinal Surgery: a Randomized Controlled Trial
Acronym: taVNS-cSSPain
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07614607
Neurologic Manifestations, Pain
Kuala Lumpur, Malaysia
View Trial DetailsNCT07238621
Anterior Cervical Discectomy, Cervical Disc Herniation
Sivas, Turkey (Türkiye)
View Trial DetailsNCT07073846
Agnosia, Morbid Obesity Requiring Bariatric Surgery
Mexico City, Mexico
View Trial DetailsNCT06758245
Agnosia, Analgesia
Istanbul, Gaziosmanpasa, Turkey (Türkiye)
View Trial Details