The Application of Electrical Stimulation in Postoperative Pain Management of Thyroid Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXiaonan Huang
About this trial
Post-thyroidectomy pain is a prevalent early postoperative complication. While pharmacological agents remain the mainstay of analgesia, their clinical application is constrained by adverse effects including nausea, respiratory depression, and gastrointestinal disturbances. Transcutaneous electrical nerve stimulation based on wrist-ankle acupuncture theory (TENS-WAA) is a non-invasive analgesic modality that has demonstrated preliminary benefits in multiple pain scenarios. Nevertheless, robust evidence for its efficacy in post-thyroidectomy pain management is still lacking, limited by single-center designs and small sample sizes in existing studies.
This trial aims to evaluate the efficacy and safety of TENS-WAA for pain control after thyroidectomy. The findings are expected to support a standardized non-pharmacological analgesic option as an adjunct to multimodal postoperative pain regimens, aligning with Enhanced Recovery After Surgery (ERAS) principles.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be over 18 years of age;
The operation time is less than 4 hours;
Postoperative VAS pain score ≥3 points ;
Clear consciousness, able to answer questions accurately, free speech, no hearing impairment;
Disqualifiers
Neck or thyroid surgery within the past ten years;
Menstruating, pregnant and lactating females;Those who are not satisfied with blood glucose control;
Skin injury or allergy; skin ulceration;
Past history of psychiatric disorder that met the diagnostic criteria of Diagnostic and Manual of Mental Disorders, DSM-IV;
Trial design
Design model
Parallel
Treatments tested in this trial
CMNS6-1 Electronic Acupuncture Therapeutic Apparatus
Device1. The time selection of acupoint treatment is to return to the ward immediately,2 and 4 hours after surgery; 2. Time of each stimulation: 30min; 3. Acupoint extraction: According to the theory of wrist and ankle acupuncture and the location of pain, the upper 1 area (the ulnar margin on the little finger side and the depression of the flexor carpi ulnaris tendon) and the upper 2 area (between the palmaris longus tendon and the flexor carpi radialis on both sides) on the affected side (bilateral for total thyroidectomy) were selected as the intervention site, and the upper and lower parallel electrodes were placed in each area, and a total of 4 electrodes (8 electrodes on both sides) were placed. 4. The parameter setting of the equipment: the frequency is set to 2Hz, the pulse width is set to 250μs, continuous wave is used, and the current intensity is the maximum tolerance of the subject's small pain threshold for 30min.
CMNS6-1 Electronic Acupuncture Therapeutic Apparatus
Device1. The time selection of acupoint treatment is to return to the ward immediately,2 and 4 hours after surgery; 2. Time of each stimulation: 30min; 3. Acupoint extraction: According to the theory of wrist and ankle acupuncture and the location of pain, the upper 1 area (the ulnar margin on the little finger side and the depression of the flexor carpi ulnaris tendon) and the upper 2 area (between the palmaris longus tendon and the flexor carpi radialis on both sides) on the affected side (bilateral for total thyroidectomy) were selected as the intervention site, and the upper and lower parallel electrodes were placed in each area, and a total of 4 electrodes (8 electrodes on both sides) were placed. (4)30 minutes of ineffective microcurrent stimulation.
Treatment groups
668 Participants
are divided into 2 treatment groupsGroup A: Sham stimulation groupSham comparator 1 intervention
Group B: TENS-WAAExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pain VAS score
VAS (Visual Analogue Scale) scoring, namely visual analogue scoring, usually employs a straight line or ruler 10 centimeters long, with0 representing the "no pain end" and 10 representing the "most intense pain". The patient marks on the straight line according to the level of pain he or she, to indicate the intensity of pain and the degree of unpleasant psychological experience. The higher the VAS score, the more painful it is. 0 points: no pain; -3 points: mild pain; 4-6 points: moderate pain; 7-9 severe pain; 10 points: unbearable pain, namely severe pain
Time frame
Evaluation time: 1) the subject returned to the ward after surgery; 2) immediately after electrical stimulation; 3) Postoperative 2 hours、Postoperative 3 hours、Postoperative 4 hours、Postoperative 9 hours、Postoperative 15 hours、Postoperative 24 hoursSecondary outcomes
1
PONV classification
The PONV score is a tool used to assess the severity of postoperative nausea and vomiting (PONV). This rating system uses a five-point scale ranging from 0 to 4.
Time frame
Postoperative 3 hours、Postoperative 9 hours、Postoperative 15 hours、Postoperative 24 hours2
40-item Quality of Recovery (QoR-40) score
The QoR-40 instrument is a tool used to assess a patient's quality of recovery after surgery. In this instrument, a higher score usually means better quality of recovery.
Time frame
Postoperative 24 hours3
Pain-related measures
Post-operative venous blood samples were collected to measure serum markers, including C-reactive protein (CRP), interleukins (ILs, including IL-6 and IL-8) and cortisol.
Time frame
8.00 am on the morning after the operation4
Safety indicators
Record the number of patients requiring additional analgesia, the total dose of medication administered, patients' post-operative vital signs, and any adverse events experienced by patients following use of the therapeutic device.
Time frame
Postoperative 24 hoursSponsors and contacts
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Xiaonan Huang
Lead sponsor
First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
Sponsor institution
Source ClinicalTrials.gov