Clinical trial NCT03187535: Effect of TEAS on PONV After Spinal Surgery
Official title: The Effect of Transcutaneous Electric Acupoint Stimulation on Post-operative Nausea and Vomiting After Spinal Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PONV
Keywords: Transcutaneous Electrical Acupoint Stimulation
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2017-06-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed research will utilize electroacupuncture, a type of needleless acupuncture that uses electrostimulation, in a randomized, double blind study, to evaluate the incidence of post-operative nausea and vomiting (PONV) in patients undergoing spinal surgeries with the transcutaneous electrical acupoint stimulation (TEAS) compared to patients without TEAS.

Detailed description: The rates of PONV will be evaluated over the first 24 hours after surgery, opioid consumption in units of morphine equivalence, and any adverse side effects will be recorded. Subjects who are included in the research will be randomly assigned to one of two groups - one group is the control group, receiving no TEAS, and the other group receiving TEAS. An anesthesiologist trained in acupuncture will utilize the Excel Pointer to locate the specific acupoints previously identified as associated with prevention PONV. Anesthesiologist will place electrocardiogram (ECG) pads at the identified acupoints prior to surgery. Subjects will be connected to the ES-130 (electro-therapy) device upon entering the operating room. Prior to the surgical closure, the unblinded researcher will initiate delivery of TEAS, or not, according to study protocol based on the randomization group of the participant. The anesthesiologist will not know the group assignment. At the end of surgery, the subject will be disconnected from the ES-130 and the ECG pads will be carefully removed. Researchers will follow up with the subject in recovery regarding any occurrence and severity of PONV, adverse events, and verbal pain scores, until 24 hours after end of surgery.

Eligibility 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)

Primary outcomes:
measure: incidence of PONV
timeFrame: up to 24 hours after surgery
measure: severity of PONV
timeFrame: up to 24 hours after surgery
Secondary outcomes:
measure: Time to first nausea/vomiting rescue medication
timeFrame: within 2 and 24 hours after surgery
measure: opioid consumption (units of morphine equivalence)
timeFrame: 2 and 24 hours after surgery
measure: incidence of adverse events
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Sergio Bergese, MD
role: PRINCIPAL_INVESTIGATOR
References: