Opioid Consumption, Postoperative, Postoperative Nausea and Vomiting (PONV), Postoperative Pain
Conditions
Keywords
Postoperative Pain, Transauricular Vagus Nerve Stimulation, tVNS, Neuromodulation, Opioid Consumption, Pain Management, Randomized Controlled Trial
Brief summary
The goal of this clinical trial is to learn whether different frequencies of transauricular vagus nerve stimulation (tVNS) can reduce postoperative pain and opioid consumption in adults undergoing abdominal or urologic surgery. It will also evaluate the effects of tVNS on recovery quality, autonomic function, and treatment safety. The main questions it aims to answer are: Does transauricular vagus nerve stimulation reduce postoperative opioid consumption during the first 24 hours after surgery? Do different stimulation frequencies (high-frequency and low-frequency tVNS) produce different effects on postoperative pain and autonomic responses? Is transauricular vagus nerve stimulation safe and well tolerated in surgical patients? Researchers will compare high-frequency tVNS, low-frequency tVNS, and sham stimulation (inactive stimulation) to determine their effects on postoperative pain and opioid requirements. Participants will: Be randomly assigned to receive high-frequency tVNS, low-frequency tVNS, or sham stimulation. Receive two 30-minute stimulation sessions, one before anesthesia and one after surgery in the post-anesthesia care unit. Undergo assessments of postoperative pain, opioid consumption, need for rescue analgesics, postoperative nausea and vomiting, heart rate changes, and quality of recovery. Be monitored for adverse events related to the intervention during the study period. A total of 174 participants will be enrolled in this single-center, randomized, double-blind, sham-controlled clinical trial.
Detailed description
Postoperative pain remains a major challenge in perioperative care and is associated with delayed recovery, increased healthcare utilization, and greater opioid consumption. Despite advances in multimodal analgesia, opioid medications continue to play a central role in postoperative pain management and may be associated with adverse effects such as nausea, vomiting, respiratory depression, and prolonged recovery. Therefore, the development of effective non-pharmacological adjunctive strategies is of considerable clinical interest. Transauricular vagus nerve stimulation (tVNS) is a non-invasive neuromodulation technique that stimulates the auricular branch of the vagus nerve through the external ear. Experimental and clinical studies suggest that vagal stimulation may modulate pain perception through activation of central autonomic pathways, enhancement of descending inhibitory pain mechanisms, and regulation of inflammatory responses. Previous clinical trials have demonstrated promising effects of tVNS on acute and chronic pain conditions, including reductions in postoperative pain scores. However, the optimal stimulation parameters for perioperative analgesia remain uncertain. In particular, the influence of stimulation frequency on clinical outcomes and autonomic responses has not been adequately investigated. Different stimulation frequencies may activate distinct neural pathways and produce different effects on pain modulation and autonomic regulation. This study is designed to evaluate the effects of different frequencies of transauricular vagus nerve stimulation applied before and after surgery in adult patients undergoing elective surgical procedures. In addition to assessing postoperative opioid requirements, the study will explore the relationship between autonomic responses and postoperative recovery. The findings may contribute to the optimization of non-pharmacological analgesic strategies and support the incorporation of transauricular vagus nerve stimulation into multimodal perioperative pain management protocols.
Interventions
Non-invasive electrical stimulation of the auricular branch of the vagus nerve applied bilaterally through ear electrodes. Stimulation is delivered before anesthesia and after surgery using predefined frequency settings.
Sham stimulation delivered using the same device and electrode placement as active stimulation. The device is activated to mimic treatment but does not deliver therapeutic electrical stimulation.
Sponsors
Study design
Masking description
Participants, outcome assessors, and data analysts will remain blinded to treatment allocation throughout the study. The researcher responsible for administering the stimulation will not be blinded because intervention assignment is required for device setup and delivery.
Intervention model description
Participants will be randomly assigned in a 1:1:1 ratio to receive high-frequency transauricular vagus nerve stimulation (60-120 Hz), low-frequency transauricular vagus nerve stimulation (10-20 Hz), or sham stimulation. Each participant will remain in the assigned group throughout the study and will receive two stimulation sessions, one before anesthesia and one after surgery. Outcomes will be compared across the three parallel groups.
Eligibility
Inclusion criteria
* Adults aged 18 to 59 years. * Undergoing elective abdominal or urologic surgery. * American Society of Anesthesiologists (ASA) physical status I-III. * Able and willing to provide written informed consent.
Exclusion criteria
* History of neurological disorders. * History of psychiatric disorders. * Inability to understand study procedures. * Pregnancy. * Cognitive impairment. * Communication difficulties that interfere with study assessments. * Auricular dermatitis or skin lesions at the stimulation site. * Pre-existing cardiac arrhythmia. * Chronic opioid use. * Implanted electronic medical devices, including pacemakers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total postoperative opioid consumption during the first 24 hours after surgery | 24 hours after surgery | Total opioid consumption during the first 24 postoperative hours, recorded according to the institutional postoperative analgesia protocol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity (VAS) | Before stimulation in the post-anesthesia care unit, immediately after stimulation, 2 hours after surgery, and 24 hours after surgery | Pain intensity measured using a 100-mm Visual Analog Scale (VAS). Pain scores will be assessed at predefined postoperative time points and compared among study groups. |
| Rescue analgesic use | Within 24 hours after surgery | Number of participants requiring rescue analgesics and total rescue analgesic administration during the first 24 postoperative hours. |
| Postoperative nausea and vomiting (PONV) | Within 24 hours after surgery | Incidence of postoperative nausea and/or vomiting and use of rescue antiemetic medication during the postoperative period. |
| Heart rate changes | Immediately before and immediately after each stimulation session (preoperative and postoperative). | Changes in heart rate measured immediately before and immediately after transauricular vagus nerve stimulation sessions as an indicator of autonomic nervous system activity. |
| Quality of Recovery (QoR-15 Score) | Baseline (preoperative) and 24 hours after surgery. | Quality of postoperative recovery assessed using the 15-item Quality of Recovery questionnaire (QoR-15). Higher scores indicate better recovery. |
| Adverse events related to transauricular Vagus Nerve Stimulation | From the first stimulation session until 24 hours after surgery. | Incidence of adverse events potentially related to the intervention, including auricular discomfort, skin irritation, headache, bradycardia, hypotension, bronchospasm, or other treatment-related events. |
Countries
Brazil
Contacts
Botucatu Medical School, São Paulo State University (UNESP)