Chronic Post-surgical Pain, Postoperative Sleep Disturbances
Conditions
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.
Interventions
OTHERPercutaneous Acupoint Acupuncture
Participants in the acupuncture group will receive manual acupuncture at four bilateral acupoints: Heart 7 (HT7 Shenmen), Pericardium 6 (PC6 Neiguan), Stomach 36 (ST36 Zusanli), and Kidney 6 (KI6 Zhaohai). Acupuncture will be performed on the night before surgery, on the night of the day of surgery, and on the first postoperative night (total of 3 sessions). Sterile disposable stainless steel needles (0.25 mm × 40 mm) will be inserted to a depth of 15-25 mm depending on location, with gentle lifting-thrusting and twisting until "Deqi" sensation (aching, heaviness, or tingling) is obtained. Needles will be retained for 30 minutes, during which manual stimulation will be applied every 10 minutes. No electrical stimulation will be used. Standard perioperative care will be provided to all participants.
OTHERSham Acupuncture
Participants in the sham acupuncture group will undergo a placebo procedure using non-penetrating sham needles (e.g., Streitberger or similar non-skin-piercing placebo needle) applied at the same acupoints (bilateral HT7, PC6, ST36, KI6) and on the same schedule (the night before surgery, the night of surgery day, and postoperative day 1; total of 3 sessions). The sham needle tip retracts into the base upon contact with the skin, producing a tactile sensation without skin penetration or Deqi. The device will be left in place for 30 minutes without manipulation, mimicking the true acupuncture procedure in appearance and duration. Standard perioperative care will be provided to all participants.
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
： 1. Patients aged 18-75 years scheduled for elective video-assisted thoracoscopic surgery (VATS) for lung cancer resection. 2. American Society of Anesthesiologists (ASA) physical status classification I-II. 3. Body Mass Index (BMI) between 18.5 and 28 kg/m². 4. Clinical tumor stage according to the 8th edition of the AJCC/UICC TNM Classification: cTis-3N0-1M0. 5. Mentally competent, able to understand and correctly use the Numeric Rating Scale (NRS) for pain assessment. 6. Willing and able to provide written informed consent prior to study participation.
Exclusion criteria
： 1. Critical preoperative condition or inability to cooperate. 2. History of sleep apnea or moderate to severe snoring. 3. Pittsburgh Sleep Quality Index (PSQI) ≥7 or Athens Insomnia Scale (AIS) score ≥6. 4. Implanted cardiac pacemaker, preoperative sinus bradycardia (heart rate ≤50 bpm), sinoatrial node disease, or second-/third-degree atrioventricular block. 5. Long-term use of anticonvulsants, antidepressants, or other psychotropic medications. 6. Known hypersensitivity or allergy to the study materials (needles/devices) or related medications. 7. Severe cardiac, hepatic, or renal dysfunction. 8. Participation in another clinical trial within the past 3 months. 9. Hearing and/or language communication impairment. 10. Pregnancy or breastfeeding. 11. Fever (body temperature ≥38.5°C) or clinical evidence of infection (hematological, radiological, and/or microbiological) prior to surgery. 12. Planned reoperation, or anticipated postoperative recurrence, severe complications, or critical illness requiring exclusion from follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Sleep Disturbance as Assessed by the Athens Insomnia Scale (AIS) | Postoperative days 1, 2, and at hospital discharge (day 3-5) | AIS is an 8-item self-report scale. A total score ≥6 indicates clinically significant insomnia/sleep disturbance. Higher scores indicate worse sleep quality. |
Countries
China
Outcome results
None listed