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At present, surgical resection remains one of the main methods for the radical treatment of lung cancer. Compared with traditional thoracotomy, Video-assisted Thoracoscopic Surgery (VATS) offers obvious advantages, such as less surgical trauma and rapid postoperative recovery. However, a certain proportion of patients will still experience moderate to severe pain after undergoing VATS. Postoperative acute pain can lead to increased postoperative pulmonary complications, prolonged hospital stays, and increased treatment costs. Additionally, it is also associated with the development of postoperative chronic pain. Therefore, effective pain management after VATS is crucial.
Researchers will compare Transcutaneous Electrical Nerve Stimulation (TENS) based on Wrist-Ankle Acupuncture theory (TENS-WAA) with a sham stimulation regimen to determine whether TENS-WAA can relieve postoperative pain in patients undergoing thoracoscopic lung resection. This study aims to enrich the existing postoperative analgesia schemes and provide a reliable basis for its clinical promotion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TENS-WAA group | Experimental | Patients assigned to the TENS-WAA group will receive transcutaneous electrical nerve stimulation (TENS) based on Wrist-Ankle Acupuncture theory (WAA) for a duration of 30 minutes after anesthesia induction, as well as at 8 hours and 24 hours postoperatively. |
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| sham TENS-WAA group | Sham Comparator | Patients assigned to the sham TENS-WAA group will receive sham stimulation （without stimulation）for a duration of 30 minutes after anesthesia induction, as well as at 8 hours and 24 hours postoperatively. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TENS-WAA | Device | Patients assigned to the TENS-WAA group will receive transcutaneous electrical nerve stimulation based on Wrist-Ankle Acupuncture theory for a duration of 30 minutes after anesthesia induction, as well as at 8 hours and 24 hours postoperatively. According to the principles of WAA, two pairs of TENS-WAA (Wuxi Jiajian Medical Device Co., Ltd.) electrode pads will be placed on the upper area 2 and 3 with the skin of the treatment area exposed, and the upper and lower juxtaposition method will be adopted. Upper area 2 is at the middle of the palmar side of the forearm, between the palmaris longus and flexor carpi radialis. Upper area 3 is between the edge of the radius and the radial artery. Stimulation parameters of TENS-WAA are alternating dense-disperse wave with a frequency of 2Hz and a pulse width of 200μs, and a frequency of 100Hz with a pulse width of 150μs, alternating every 3 seconds ，intensity required to reach the maximum tolerable level without causing pain. |
| Measure | Description | Time Frame |
|---|---|---|
| The dynamic VAS score | Independent investigators will assess the postoperative dynamic pain (pain during activities or coughing) by utilizing a visual analogue scale (VAS) ranging from 0 to 10. The two ends of the straight line represent "no pain at all" and "the worst pain imaginable," respectively. Patients are required to mark their corresponding position on the line based on their perception of pain, and the numerical value corresponding to this position serves as the patient's pain score. | at 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The static VAS score | Postoperative static pain (pain at rest) will be quantified using the VAS. | at 6 hours, 12 hours, 24 hours and 48 hours after surgery |
| The dynamic VAS score | Postoperative dynamic pain (pain during activities or coughing) will be quantified using the VAS. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiafeng Wang, M.D. | Changhai hospital, Shanghai, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai hospital | Shanghai | Shanghai Municipality | 200090 | China |
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| Sham (No Treatment) | Device | Patients assigned to the sham TENS-WAA group will receive sham stimulation for a duration of 30 minutes after anesthesia induction, as well as at 8 hours and 24 hours postoperatively. Researchers will attach the electrode patches at the same location, set the parameters to the same frequency, pulse width, and minimum current intensity as the TENS-WAA group, but do not activate the device, leaving it in place for 30 minutes at each time point. |
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| at 6 hours, 12 hours and 48 hours after surgery |
| Opioid consumption during surgery | The consumption of opioids during the surgery will be converted into morphine equivalent, and then the total will be calculated. | at the end of the surgery |
| Postoperative opioid consumption | The consumption of opioids within 48 hours after surgery will be converted into morphine equivalent. | at 48 hours after surgery |
| Consumption of NSAIDs | The consumption of Non-steroidal Anti-inflammatory Drugs within 48 hours after surgery will be recorded. | at 48 hours after surgery |
| The 15-item QoR score | The 15-item QoR score is used to assess the quality of recovery after surgery, which ranges from 0 to 150, and higher QoR-15 scores indicate better postoperative recovery. | at 24 hours and 48 hours after surgery |
| The HADS score | The Hospital Anxiety and Depression Scale (HADS) is used to evaluate patients' anxiety and depression. Scores on the HADS range from 0 to 21, and higher scores indicate more severe anxiety or depression. | at 24 hours and 48 hours after surgery |
| The AIS score | The Athens Insomnia Scale (AIS) is used to assess the quality of sleep after surgery. Scores on the AIS range from 0 to 24, and higher scores indicate worse sleep quality. | The morning of the first day after surgery and the morning of the second day after surgery. |
| Incidence of PONV | The researchers will observe whether patients experience nausea and vomiting after surgery. | at 48 hours after surgery |
| The duration of hospital stay | The period from the end of surgery to the patient's discharge from the hospital will be recorded. | on the 1 day of the patient's discharge from the hospital |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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