NCT07633444 Transauricular Vagus Nerve Stimulation Frequencies for Postoperative Pain
| NCT ID | NCT07633444 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federal University of Bahia |
| Condition | Postoperative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 174 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 174 participants in total. It began in 2026-06-01 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Rodrigo M Vieira, MD
PRINCIPAL INVESTIGATOR
Botucatu Medical School, São Paulo State University (UNESP)
Frequently Asked Questions
Who can join the NCT07633444 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 59 Years, studying Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07633444 currently recruiting?
Yes, NCT07633444 is actively recruiting participants. Contact the research team at rlalves@ufba.br for enrollment information.
Where is the NCT07633444 trial being conducted?
This trial is being conducted at Salvador, Brazil.
Who is sponsoring the NCT07633444 clinical trial?
NCT07633444 is sponsored by Federal University of Bahia. The principal investigator is Rodrigo M Vieira, MD at Botucatu Medical School, São Paulo State University (UNESP). The trial plans to enroll 174 participants.