Using electroacupuncture to reduce nausea after spinal surgery
The Effect of Transcutaneous Electric Acupoint Stimulation on Post-operative Nausea and Vomiting After Spinal Surgery
This study is testing if a special type of acupuncture can help reduce nausea and vomiting after spinal surgery for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT03187535 on ClinicalTrials.gov |
What this trial studies
This research evaluates the effectiveness of transcutaneous electrical acupoint stimulation (TEAS) in preventing post-operative nausea and vomiting (PONV) in patients undergoing spinal surgery. In a randomized, double-blind design, participants will be assigned to either receive TEAS or not during their surgery. The study will monitor the incidence of PONV, opioid consumption, and any adverse effects for 24 hours post-surgery. An anesthesiologist trained in acupuncture will apply the TEAS using specific acupoints identified for their potential to alleviate nausea.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older undergoing elective spinal surgery expected to last no more than four hours.
Not a fit: Patients with a history of vestibular disease, recent nausea or vomiting, or those with certain medical conditions or devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of PONV in patients undergoing spinal surgery, improving recovery experiences.
How similar studies have performed: Previous studies have shown promise in using electroacupuncture techniques for managing PONV, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female patients , 18 or older * American Society of Anesthesiologists (ASA) classification I or II or III * Undergoing elective spinal surgery expected to last no more than four hours (from induction of anesthesia to extubation). * Capable and willing to consent Exclusion Criteria: * Neuraxial (intrathecal or epidural) block * Significant ongoing history of vestibular disease or dizziness * Nausea or vomiting within 24 hours prior to surgery, use of antiemetic or emetogenic drugs within 3 days of surgery * Documented alcohol or substance abuse within 3 months before the surgery * Limb abnormalities such as burn and amputation. * Poorly controlled diabetes mellitus (fasting plasma glucose \>126 mg/dL or \<70 mg/dL) * Implantation of metal/electrical devices, such as nerve stimulator, cardiac pacemaker, cardioverter, defibrillator and internal hearing aids * Rash, local infection, keloid, any dermatologic condition that could interfere with the acupoint stimulation area * Documented alcohol or substance abuse within 3 months before surgery * Presence of clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, or schizophrenia * Chemotherapy or radiation therapy within 7 days before surgery * Investigational product use within 3 months prior surgery * Any condition, which in the opinion of the investigator would make subject ineligible for participation in the study (history of unstable cardiovascular, pulmonary, renal, hepatic, seizures) * Special population (prisoners, pregnant and lactating women)
Where this trial is running
Columbus, Ohio
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Sergio Bergese, MD — Ohio State University
- Study coordinator: Juan Fiorda, MD, PhD
- Email: juan.fiorda@osumc.edu
- Phone: 614-293-3559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.