Effects of taVNS on Postoperative Pain in Complex Spinal Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing elective general anesthesia for complex spinal surgeries
Age ≥ 18 years
ASA classification I-III
Disqualifiers
Ulceration or infection of the auricle skin
Bradycardia (heart rate of < 60 beats/min） or third-degree atrioventricular block
Implanted cardiac pacemaker or other electronic devices
Mental disorders or long-term use of psychotropic medications
Trial design
Design model
Parallel
Treatments tested in this trial
transauricular auricular vagus nerve stimulation
DevicePatients will receive five taVNS sessions, with each session lasting 60 minutes.
transauricular auricular vagus nerve stimulation
DevicePatients will receive five sham taVNS sessions, with each session lasting 60 minutes.
Treatment groups
98 Participants
are divided into 2 treatment groupsGroup A: taVNS groupActive comparator 1 intervention
Group B: sham groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Opioid consumption 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 postoperativelySecondary outcomes
1
Pain score
Maximum, minimum, and mean NRS on postoperative days 1, 2, and 3, and NRS before and after taVNS stimulation.
Time frame
within 72 hours postoperatively2
Use of PCIA
Including the first compression time of PCA and times of PCA within 72 hours postoperatively
Time frame
Within 72 hours postoperatively3
Hospital Anxiety and Depression Scale (HADS) within 3 months postoperatively
Assessed by HADS within 3 months postoperatively
Time frame
on the 3 months4
Pittsburgh Sleep Quality Index (PSQI) within 3 months postoperatively
assessed by PSQI within 3 months postoperatively
Time frame
on the 3 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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