NCT07662733RecruitingNot Applicable
Effectiveness of Perioperative Percutaneous Acupoint Acupuncture on Postoperative Sleep Disturbances in Patients Undergoing Video-Assisted Thoracoscopic Lung Cancer Resection: A Prospective, Randomized, Single-Blind, Superiority Controlled Trial
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine2 sites in 1 country316 target enrollmentStarted: June 13, 2025Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 316
- Locations
- 2
Study Overview
Brief Summary
This study evaluates whether acupuncture at specific body points before and after surgery can improve sleep quality and reduce long-term postoperative pain in patients undergoing video-assisted thoracoscopic lung cancer resection. Eligible adult patients will be randomly assigned to receive either true acupuncture or sham (placebo) acupuncture in addition to standard care. Chronic pain will be assessed during hospital stay and up to 6 months after surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 18-75 years scheduled for elective video-assisted thoracoscopic surgery (VATS) for lung cancer resection.
- •American Society of Anesthesiologists (ASA) physical status classification I-II.
- •Body Mass Index (BMI) between 18.5 and 28 kg/m².
- •Clinical tumor stage according to the 8th edition of the AJCC/UICC TNM Classification: cTis-3N0-1M
- •Mentally competent, able to understand and correctly use the Numeric Rating Scale (NRS) for pain assessment.
- •Willing and able to provide written informed consent prior to study participation.
Exclusion Criteria
- •Critical preoperative condition or inability to cooperate.
- •History of sleep apnea or moderate to severe snoring.
- •Pittsburgh Sleep Quality Index (PSQI) ≥7 or Athens Insomnia Scale (AIS) score ≥
- •Implanted cardiac pacemaker, preoperative sinus bradycardia (heart rate ≤50 bpm), sinoatrial node disease, or second-/third-degree atrioventricular block.
- •Long-term use of anticonvulsants, antidepressants, or other psychotropic medications.
- •Known hypersensitivity or allergy to the study materials (needles/devices) or related medications.
- •Severe cardiac, hepatic, or renal dysfunction.
- •Participation in another clinical trial within the past 3 months.
- •Hearing and/or language communication impairment.
- •Pregnancy or breastfeeding.
- •Fever (body temperature ≥38.5°C) or clinical evidence of infection (hematological, radiological, and/or microbiological) prior to surgery.
- •Planned reoperation, or anticipated postoperative recurrence, severe complications, or critical illness requiring exclusion from follow-up.
Investigators
LIna Huang
Chief Physician, Department of Anesthesiology, Shanghai First People's Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study Sites (2)
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