Effect of Transcutaneous Electrical Nerve Stimulation Based on Wrist-ankle Acupuncture Theory on Postoperative Pain After Video-assisted Thoracoscopic Surgery

NCT06744166 | Completed DMC

• 1 other identifier: TENS-WAA-VATS
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Video-assisted Thoracoscopic Surgery (VATS)

Keywords

Video-assisted thoracoscopic surgery (VATS); Postoperative pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• 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

Study Arms (2)

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.

Device: TENS-WAA

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.

Device: Sham (No Treatment)

Interventions

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.

TENS-WAA group

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.

sham TENS-WAA group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai hospital

Shanghai, Shanghai Municipality, 200090, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Jiafeng Wang, M.D.

  Changhai hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 20, 2024
• Study Start: February 6, 2025
• Primary Completion: June 20, 2025
• Study Completion: June 20, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

CN (1)