Effectiveness of Perioperative Percutaneous Acupuncture on Postoperative Sleep Disturbances and Chronic Pain in Patients Undergoing Video-Assisted Thoracoscopic Lung Cancer Resection: A Prospective, Randomized, Single-Blind, Superiority Controlled Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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-3N0-1M0.

Disqualifiers

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 ≥6.

Implanted cardiac pacemaker, preoperative sinus bradycardia (heart rate ≤50 bpm), sinoatrial node disease, or second-/third-degree atrioventricular block.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Percutaneous Acupoint Acupuncture

    Other intervention

    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.

  • Sham Acupuncture

    Other intervention

    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.

Treatment groups

316 Participants
are divided into 2 treatment groups
Group A: Acupuncture GroupExperimental treatment 1 intervention
Group B: Sham Acupuncture GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Postoperative Sleep Disturbance as Assessed by the Athens Insomnia Scale (AIS)

AIS is an 8-item self-report scale. A total score ≥6 indicates clinically significant insomnia/sleep disturbance. Higher scores indicate worse sleep quality.

Time frame
Postoperative days 1, 2, and at hospital discharge (day 3-5)

Secondary outcomes

Other outcomes

Sponsors and contacts

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