Clinical trial NCT06744166: Effect of Transcutaneous Electrical Nerve Stimulation Based on Wrist-ankle Acupuncture Theory on Postoperative Pain After Video-assisted Thoracoscopic Surgery
Official title: Effect of Transcutaneous Electrical Nerve Stimulation Based on Wrist-ankle Acupuncture Theory on Postoperative Pain After Video-assisted Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Pain
Video-assisted Thoracoscopic Surgery (VATS)
Keywords: Video-assisted thoracoscopic surgery (VATS)
Postoperative pain
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: The dynamic VAS score
timeFrame: at 24 hours after surgery
Secondary outcomes:
measure: The static VAS score
timeFrame: at 6 hours, 12 hours, 24 hours and 48 hours after surgery
measure: The dynamic VAS score
timeFrame: at 6 hours, 12 hours and 48 hours after surgery
measure: Opioid consumption during surgery
timeFrame: at the end of the surgery
measure: Postoperative opioid consumption
timeFrame: at 48 hours after surgery
measure: Consumption of NSAIDs
timeFrame: at 48 hours after surgery
measure: The 15-item QoR score
timeFrame: at 24 hours and 48 hours after surgery
measure: The HADS score
timeFrame: at 24 hours and 48 hours after surgery
measure: The AIS score
timeFrame: The morning of the first day after surgery and the morning of the second day after surgery.
measure: Incidence of PONV
timeFrame: at 48 hours after surgery
measure: The duration of hospital stay
timeFrame: on the 1 day of the patient's discharge from the hospital
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai hospital
state: Shanghai
Study officials:
affiliation: Changhai hospital, Shanghai, China
name: Jiafeng Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: