Effect of Transcutaneous Electrical Nerve Stimulation Based on Wrist-ankle Acupuncture Theory on Postoperative Pain After Video-assisted Thoracoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- The dynamic VAS score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged over 18 years
- •American Society of Anesthesiologists (ASA) physical status of I-III
- •Patients scheduled for elective unilateral lobectomy via video-assisted thoracoscopic surgery (VATS) for lung cancer under general anesthesia
- •Informed consent signed
排除标准
- •History of liver, kidney, heart, lung, or brain disease
- •Psychiatric disorder or cognitive impairment
- •Chronic pain, daily use of analgesics, or alcohol dependence
- •Routine or recent acupuncture treatment
- •Contraindications to TENS (with pacemaker or metallic implants, allergy to surface electrodes, with skin sensory disorders, skin ulceration, unhealed scars, or adhesions)
研究组 & 干预措施
TENS-WAA group
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.
干预措施: TENS-WAA (Device)
sham TENS-WAA group
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.
干预措施: Sham (No Treatment) (Device)
结局指标
主要结局
The dynamic VAS score
时间窗: at 24 hours after surgery
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.
次要结局
- The static VAS score(at 6 hours, 12 hours, 24 hours and 48 hours after surgery)
- The dynamic VAS score(at 6 hours, 12 hours and 48 hours after surgery)
- Opioid consumption during surgery(at the end of the surgery)
- Postoperative opioid consumption(at 48 hours after surgery)
- Consumption of NSAIDs(at 48 hours after surgery)
- The 15-item QoR score(at 24 hours and 48 hours after surgery)
- The HADS score(at 24 hours and 48 hours after surgery)
- The AIS score(The morning of the first day after surgery and the morning of the second day after surgery.)
- Incidence of PONV(at 48 hours after surgery)
- The duration of hospital stay(on the 1 day of the patient's discharge from the hospital)
研究者
Jia-feng Wang
associate chief physician
Changhai Hospital