Clinical trial NCT06397807: Postoperative Pain Management on Patients Undergoing Lung Tumor Resection
Official title: Postoperative Pain Management on Patients Undergoing Video-assisted Thoracoscopic (VATS) Lung Tumor Resection: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Postoperative Pain
Lung Cancer
Lung Tumor
Keywords: Video-assisted thoracoscopic (VATS) lung tumor resection
Naldebain
Dinalbuphine sebacate
Multimodal analgesia
Enhanced Recovery After Surgery
ERAS
MMA
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient scheduled to have video-assisted thoracoscopic lung tumor resection in China Medical University Hospital.

Brief summary: Multimodal analgesia (MMA) is an essential part of Enhanced Recovery After Surgery (ERAS) protocol. The principle of MMA is to manage pain with analgesics of multiple classes acting on distinct target sites through different strategies. MMA can reduce the adverse reaction caused by opioids and improve the quality of recovery from surgery. Inadequate postoperative pain management will increase the risk of complications, including pneumonia, deep vein thrombosis, infection, delayed surgical healing, and chronic postoperative pain.

Detailed description: This prospective, observational study is planned to investigate the efficacy of different MMA regimens conducting in our hospital. Patients undergoing video-assisted thoracoscopic (VATS) lung tumor resection will be invited to participate in the study and grouped based on the MMA regimens. Anxiety, quality of recovery, pain intensity will be evaluated pre- and post-operatively. Demographic data, surgery record, medicine record and postoperative complications will be gained from medical history system and analyzed.

Eligibility criteria: Inclusion Criteria:

1. aged above 18.
2. diagnosed as lung cancer.
3. planning to undergo primary, video-assisted thoracoscopic lung tumor resection.
4. American Society of Anesthesiology Physical Class 1\~3.

Exclusion Criteria:

1. unable to take assessments of the endpoints.
2. having this surgery in an emergency.
3. surgery involving other orangs, such as esophagus and stomach.
4. severe abnormality of cardiac, hepatic, or renal function.
5. allergic to opioids.
6. allergic to NSAIDs.
7. diagnosed as chronic pain or chronic use of analgesics.
8. unsuitable for participation judged by investigator.

Primary outcomes:
measure: Postoperative pain intensity
timeFrame: Within 3 days after surgery
Secondary outcomes:
measure: Consumption of analgesics
timeFrame: Within 7 days after surgery
measure: GAD-7
timeFrame: At baseline, 7 days and 3 months after surgery
measure: QoR-15
timeFrame: At baseline, 7 days and 3 months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: China Medical University Hospital
name: Hsin-Yuan Fang
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University Hospital
name: Po-Han Li
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University Hospital
name: Kin-Shing Poon
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University Hospital
name: Hsiurong Liao
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University Hospital
name: Tzu-Min Huang
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University Hospital
name: Yu-Cheng Shen
role: PRINCIPAL_INVESTIGATOR
References: