Acute Pain Clinical Trials

Find Acute Pain Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 59
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Brazil
Hospital Universitário Professor Edgard Santos, Federal University of Bahia (HUPES-UFBA)
RECRUITING
Salvador
Contact Information
Primary
Rodrigo L Alves, MD, PhD
rlalves@ufba.br
71 99961-9818
Backup
João Paulo A de Carvalho
joaoaureliano@ufba.br
75 98295-3834
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2026-12-04
Participants
Target number of participants: 174
Treatments
Experimental: High-Frequency tVNS
Participants will receive active transauricular vagus nerve stimulation (tVNS) at a frequency of 60-120 Hz. Stimulation will be applied bilaterally to the auricular branch of the vagus nerve for 30 minutes before anesthesia and for 30 minutes after surgery. Current intensity will be adjusted between 2 and 6 mA according to participant tolerance.
Experimental: Low-Frequency tVNS
Participants will receive active transauricular vagus nerve stimulation (tVNS) at a frequency of 10-20 Hz. Stimulation will be applied bilaterally to the auricular branch of the vagus nerve for 30 minutes before anesthesia and for 30 minutes after surgery. Current intensity will be adjusted between 2 and 6 mA according to participant tolerance.
Sham_comparator: Sham tVNS
Participants will receive sham transauricular vagus nerve stimulation. The device will be positioned and activated to mimic active treatment, but stimulation will be discontinued shortly after initiation. Participants will undergo two 30-minute sessions, one before anesthesia and one after surgery, while maintaining blinding to treatment allocation.
Related Therapeutic Areas
Sponsors
Leads: Federal University of Bahia
Collaborators: Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil

This content was sourced from clinicaltrials.gov