Analgesia Clinical Trial
Official title:
Study on Standardization and Clinical Evaluation of Acupuncture and Drug Compound Technology to Accelerate Perioperative Rehabilitation of Pneumonectomy
Verified date | July 2021 |
Source | Shanghai Yueyang Integrated Medicine Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This project intends to develop a clinical randomized controlled study of ADCT (acupuncture and drug compound technology) in accelerating the recovery of patients during the perioperative period of pneumonectomy. The ADCT the investigators proposed is a characteristic technology that uses acupuncture-related technologies to replace part of the dosage of narcotic drugs. With the support of the investigators' preliminary research results of ADCT, sequential TEAS (transcutaneous electrical acupoints stimulation) treatment before, during and after the operation promoted recovery after thoracoscopic lung resection. Compared with electroacupuncture, TEAS has the advantages of non-invasive, easy to repeat, safe, and low cost, and it has widely been accepted by patients. In view of the investigators' previous clinical observations and conclusions, ADCT in the perioperative period of lung resection surgery can indeed play a good role in organ protection and reduce surgical stress reaction. Therefore, it is necessary to further clarify the advantages and application value of ADCT and provide evidence-based medical evidence. is in accelerating the perioperative period of rehabilitation, it is imminent to formulate a standardized, practical, effective and conducive to the promotion and application of acupuncture and medicine compound technology in hospitals at all levels during the perioperative period of combined Chinese and Western medicine prevention and treatment programs. In order to formulate and optimize the application of ADCT in the entire perioperative period of lung resection surgery, and promote the establishment of the first perioperative rehabilitation management and treatment model based on ADCT in accelerated lung resection surgery to facilitate clinical promotion.
Status | Not yet recruiting |
Enrollment | 76 |
Est. completion date | December 31, 2022 |
Est. primary completion date | April 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Patients diagnosed with pulmonary nodules requiring thoracoscopic surgery. - Understand and agree to participate in this study and sign the informed consent. Exclusion Criteria: - Patients who had previously received TEAS. - Patients with local skin infection of acupoints. - Patients with nerve damage in the upper or lower extremities. - Participants who had participated in or were participating in other clinical trials within 1 month prior to enrollment. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Shanghai Yueyang Integrated Medicine Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative chest tube removal time (h) | The time from the end of surgery to the removal of the thoracic catheter will be recorded | up to 2 weeks after surgery | |
Secondary | First exhaust time after operation (h) | The time between the patient's first exhaust and the end of surgery will be recorded. | up to 1 week after surgery | |
Secondary | First defecation time after operation (h) | The time between the patient's first defecation and the end of surgery will be recorded. | up to 1 week after surgery | |
Secondary | Visual Analog Scale of Pain | Visual analogue scale of pain will be used to evaluate the pain level of the surgical incision, and the score will be recorded.The 10cm sliding scale has 10 scales on one side, and the two ends are respectively "0" and "10" points. A point of 0 means no pain, and a point of 10 means the most severe pain that is unbearable. | The third day before surgery, the second TEAS treatment on the first day after surgery, and the second TEAS treatment on the second day after surgery. | |
Secondary | Duration of postoperative hospital stay (d) | Days between the day of discharge and surgery will be recorded. | up to 2 weeks after surgery | |
Secondary | C-reactive protein (CRP,mg/L) | Inflammatory biomarker CRP will be determined by immunotransmission turbidimetry. | The third day before surgery, the second TEAS treatment on the first day after surgery, and the second TEAS treatment on the second day after surgery. | |
Secondary | Noradrenaline (NE,µg/L) | Stress response biomarker NE will be determined by immunotransmission turbidimetry. | The third day before surgery, the second TEAS treatment on the first day after surgery, and the second TEAS treatment on the second day after surgery. | |
Secondary | Postoperative stay time in the intensive care unit (h) | Record the time between the day of patient transfer from the ICU and the end of surgery. | up to 1 week after surgery | |
Secondary | Postoperative antibiotics use days (d) | Duration of postoperative antibiotics use will be recorded | up to 1 week after surgery | |
Secondary | Inpatient medical expenses | Record expenses incurred during the patient's hospitalization | up to 2 weeks after surgery |
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