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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
98
Patients will receive five taVNS sessions, with each session lasting 60 minutes.
Patients will receive five sham taVNS sessions, with each session lasting 60 minutes.
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 postoperatively
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 postoperatively
Use of PCIA
Including the first compression time of PCA and times of PCA within 72 hours postoperatively
Time frame: Within 72 hours postoperatively
Hospital Anxiety and Depression Scale (HADS) within 3 months postoperatively
Assessed by HADS within 3 months postoperatively
Time frame: on the 3 months
Pittsburgh Sleep Quality Index (PSQI) within 3 months postoperatively
assessed by PSQI within 3 months postoperatively
Time frame: on the 3 months
Quality of Recovery Scale (QoR15) within 3 months postoperatively
Assessed by QoR15 within 3 months postoperatively
Time frame: on the 3 months
Incidence of chronic pain
Assessed by NRS at 3 months postoperatively
Time frame: at 3 months postoperatively
Functional recovery indicators
Including time to first flatus and time to first bowel movement
Time frame: up to 2 weeks
Length of hospital stay
Time frame: up to 1 month
Adverse events
Time frame: on the 3 months
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