Actively Recruiting

Phase Not Applicable
Age: 18Years - 59Years
All Genders
ID07633444

Effects of Different Frequencies of Transauricular Vagus Nerve Stimulation on Postoperative Pain: A Randomized, Double-Blind, Sham-Controlled Trial With Preoperative and Postoperative Sessions

Led by Federal University of Bahia · Updated on 2026-06-08

174

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

F

Federal University of Bahia

Lead Sponsor

F

Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether different frequencies of transauricular vagus nerve stimulation (tVNS) can reduce postoperative pain and opioid use in adults undergoing abdominal or urologic surgery. This study also aims to assess how tVNS affects recovery quality, autonomic nervous system function, and treatment safety. The trial compares high-frequency tVNS, low-frequency tVNS, and sham stimulation to understand their different impacts on pain and autonomic responses after surgery. Participants are randomly assigned to receive either high-frequency tVNS (60-120 Hz), low-frequency tVNS (10-20 Hz), or sham stimulation, delivered bilaterally to the ear's vagus nerve branch. Each participant undergoes two 30-minute stimulation sessions: one before anesthesia and one after surgery in the post-anesthesia care unit. The stimulation current is adjusted between 2 and 6 mA based on comfort. Sham stimulation mimics active treatment without delivering electrical pulses. During the study, participants will be assessed for postoperative pain intensity, opioid consumption, need for additional pain medications, nausea, vomiting, heart rate changes, and overall recovery quality. Researchers will monitor for any adverse events related to the stimulation from the first session until 24 hours after surgery. The primary outcome is total opioid use in the first 24 hours post-surgery. The study will enroll 174 adults aged 18 to 59 years and lasts through 24 hours after surgery for outcome measurement.

CONDITIONS

Brief Title

Transauricular Vagus Nerve Stimulation Frequencies for Postoperative Pain

Who Can Participate

Age: 18Years - 59Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Day of surgery

Participants receive transauricular vagus nerve stimulation or sham stimulation in two sessions: one 30-minute session before anesthesia and one 30-minute session after surgery.

2 sessions (preoperative and postoperative)

Follow-up

Duration - 24 hours after surgery

Participants are monitored for postoperative pain, opioid consumption, nausea, and recovery during the first 24 hours after surgery.

Multiple assessments within 24 hours post-surgery

Trial Site Locations

Total: 1 location

1

Hospital Universitário Professor Edgard Santos, Federal University of Bahia (HUPES-UFBA)

Salvador, Estado de Bahia, Brazil, 40170-110

Actively Recruiting

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Research Team

R

Rodrigo L Alves, MD, PhD

J

João Paulo A de Carvalho

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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