Transcutaneous Electrical Acupoint Stimulation on Postoperative Pharyngeal Pain

NCT ID: NCT07117123

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-07-30

Brief Summary

Thyroid surgery is a common type of surgery in thyroid and breast surgery, mainly used to treat benign and malignant thyroid diseases. Despite the continuous progress in surgical techniques and anesthesia management, postoperative sore throat (POST) is still one of the most common adverse reactions in the perioperative period. It is reported that the incidence of POST in patients undergoing general anesthesia is about 15%-62%, while the incidence in the thyroid surgery population can be as high as 68%-80%. POST not only increases the patient's postoperative discomfort, but also may affect swallowing and language functions, prolong hospitalization time, reduce the quality of postoperative recovery, and increase medical costs. Therefore, effectively reducing the incidence and severity of POST is of great significance for improving the prognosis of patients after thyroid surgery.

The mechanism of postoperative sore throat after thyroid surgery is relatively complex, mainly involving two aspects. First, endotracheal intubation is a necessary operation for general anesthesia. The mechanical stimulation, improper airbag pressure, unreasonable catheter model selection, and rough intubation operation can all lead to pharyngeal mucosal damage, congestion, and edema, thereby causing acute POST. Secondly, thyroid surgery itself may also cause pharyngitis, such as traction and compression of the trachea, recurrent laryngeal nerve and pharyngeal soft tissue during surgery, excessive backward tilt of the head and neck during surgery, and local stimulation caused by recurrent laryngeal nerve function monitoring. The above factors work together to cause the incidence and severity of POST in thyroid surgery patients to be significantly higher than other types of surgery.

At present, measures to reduce POST mainly include reducing the inner diameter of the tracheal tube, controlling the airbag pressure, lubricating the tracheal tube, and using glucocorticoids or local anesthetics, but the effect is limited, and some interventions have the risk of drug side effects. In recent years, transcutaneous electrical acupoint stimulation (TEAS) as a non-invasive and non-traumatic intervention has shown good application prospects in relieving perioperative stress, reducing nausea and vomiting, and promoting gastrointestinal function recovery. Studies have shown that TEAS can effectively relieve a variety of postoperative discomfort symptoms, including laryngeal discomfort and pharyngitis, by regulating the autonomic nervous system, activating the endogenous analgesic system, and reducing the levels of inflammatory factors (such as IL-6 and TNF-α).

Among the many optional acupoints, Lieque (LU7) and Zhaohai (KI6) have been used in the treatment of throat diseases in ancient literature due to their status as "eight meridian intersection points". Modern studies have also confirmed that this acupoint combination has a clear effect on improving throat foreign body sensation, pharyngeal pain and hoarseness. However, there is currently no prospective randomized controlled study focusing on Lieque and Zhaohai acupoints combined with TEAS intervention for people with throat pain after thyroid surgery. Therefore, this study intends to use TEAS intervention on bilateral Lieque and Zhaohai acupoints to comprehensively observe the effect on the incidence and severity of throat pain after thyroid surgery, and evaluate its effect on postoperative nausea and vomiting, anxiety scores and hemodynamic indicators, aiming to provide new non-drug intervention strategies and evidence-based basis for the management of accelerated recovery after thyroid surgery (ERAS).

The goal of this clinical trial is to evaluate whether transcutaneous electrical acupoint stimulation (TEAS) can reduce postoperative sore throat (POST) and improve recovery quality in adult patients undergoing thyroid surgery under general anesthesia.

The main questions it aims to answer are:

Can TEAS at bilateral LU7 (Lieque) and KI6 (Zhaohai) acupoints reduce the incidence and severity of POST within 48 hours after thyroid surgery? Does TEAS influence postoperative nausea and vomiting, anxiety scores, and perioperative hemodynamic stability? Researchers will compare a TEAS group receiving active electrical stimulation at LU7 and KI6 with a control group receiving sham stimulation without current to see if TEAS results in improved postoperative comfort and faster recovery.

Participants will:

Be randomly assigned to TEAS or control group Undergo TEAS or sham stimulation for 30 minutes before induction of anesthesia Receive standard general anesthesia and thyroid surgery Be followed up for 48 hours postoperatively for sore throat assessment, discomfort scores, and related indicators

Conditions

Sore Throat After Thyroid Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

TEAS group

If you are randomly assigned to the transcutaneous electrical acupoint stimulation (TEAS) group, after you enter the anesthesia preparation, the doctor will stick special electrodes on your wrist (Lieque point) and the inside of your ankle (Zhaohai point), and connect the electrical stimulation device (Han's Pain Treatment Device, Nanjing Jisheng Medical Technology Co., Ltd., which has been clinically used and provided by this project team). The current intensity will gradually increase from a small amount to the maximum level you can tolerate (starting from 1mA, not exceeding the maximum safety range of 10mA). The entire transcutaneous electrical acupoint stimulation lasts for 30 minutes. This electrical stimulation is non-traumatic and painless. Most people only feel slight numbness, swelling, and heat.

Group Type: EXPERIMENTAL

Transcutaneous electrical acupoint stimulation

Intervention Type: DEVICE

The doctor will stick special electrodes on your wrist (Lieque point) and the inside of your ankle (Zhaohai point), and connect the electrical stimulation device (Han's Pain Treatment Device, Nanjing Jisheng Medical Technology Co., Ltd., which has been clinically used and provided by this project team). The current intensity will gradually increase from a small amount to the maximum level you can tolerate (starting from 1mA, not exceeding the maximum safety range of 10mA). The entire transcutaneous acupoint electrical stimulation lasts for 30 minutes. This electrical stimulation is non-traumatic and painless. Most people only feel slight numbness, swelling, and heat.

Control group

Electrodes were applied to the same acupoints (bilateral Lieque and Zhaohai points), but no electrical stimulation was performed. Other operations were consistent with those in the intervention group.

Group Type: PLACEBO_COMPARATOR

No electrical stimulation

Intervention Type: OTHER

The doctor will attach special electrodes to your wrist (Lieque point) and the inside of your ankle (Zhaohai point), and connect them to an electrical stimulation device (Han's pain treatment device, Nanjing Jisheng Medical Technology Co., Ltd., which has been clinically used and is provided by this project team). No electricity (i.e. no stimulation)

Interventions

Transcutaneous electrical acupoint stimulation

The doctor will stick special electrodes on your wrist (Lieque point) and the inside of your ankle (Zhaohai point), and connect the electrical stimulation device (Han's Pain Treatment Device, Nanjing Jisheng Medical Technology Co., Ltd., which has been clinically used and provided by this project team). The current intensity will gradually increase from a small amount to the maximum level you can tolerate (starting from 1mA, not exceeding the maximum safety range of 10mA). The entire transcutaneous acupoint electrical stimulation lasts for 30 minutes. This electrical stimulation is non-traumatic and painless. Most people only feel slight numbness, swelling, and heat.

Intervention Type: DEVICE

No electrical stimulation

The doctor will attach special electrodes to your wrist (Lieque point) and the inside of your ankle (Zhaohai point), and connect them to an electrical stimulation device (Han's pain treatment device, Nanjing Jisheng Medical Technology Co., Ltd., which has been clinically used and is provided by this project team). No electricity (i.e. no stimulation)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Undergoing thyroid surgery under general anesthesia, including both open and endoscopic approaches
• Provision of written informed consent by the patient or a legally authorized representative

Exclusion Criteria

• Failed tracheal intubation or requirement for emergency tracheotomy during surgery
• Requirement for reoperation due to postoperative complications such as bleeding or nerve injury
• Presence of severe cardiopulmonary disease (ASA physical status ≥ IV) or long-term use of corticosteroids
• Incomplete clinical data or inability to complete follow-up

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

XiaoLiang Wang

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

KY20250624-13

Identifier Type: -

Identifier Source: org_study_id