Lung Cancer, Lung Tumor, Postoperative Pain
Conditions
Keywords
Video-assisted thoracoscopic (VATS) lung tumor resection, Naldebain, Dinalbuphine sebacate, Multimodal analgesia, Enhanced Recovery After Surgery, ERAS, MMA
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.
Interventions
Dinalbuphine sebacate (DS) is a long-acting injectable. With oil-based formulation, DS will slowly releases to blood vessel and be hydrolyzed to nalbuphine after intramuscularly injection. The analgesic effect lasts around 5 to 7 days.
DRUGAnalgesic injectables
Opioids, NSAIDs or acetamol will be administrated as need.
DRUGEnteral analgesics
Opioids, NSAIDs or acetaminophen will be prescribed if necessary.
Sponsors
China Medical University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity | Within 3 days after surgery | Pain intensity is assessed by numerical rating scale (NRS) daily during hospital stay after delivery. NRS is a 11-point scale which labeled from zero (no pain) to ten (worst pain). The area under the curve of NRS are calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Consumption of analgesics | Within 7 days after surgery | The mean total consumption of analgesics during the hospital stay after delivery. |
| GAD-7 | At baseline, 7 days and 3 months after surgery | This self-administered patient questionnaire is used as a screening tool and severity measure for generalised anxiety disorder (GAD). Respondents are asked to rate each item for frequency of occurrence using a 4-point Likert scale (Not at all = 0, Several days = 1, More than half the days = 2, and Nearly every day = 3). All responses are summed to calculate the total GAD-7 score. |
| QoR-15 | At baseline, 7 days and 3 months after surgery | The quality of recovery-15 (QoR-15) is a patient-reported outcome measurement measuring QoR after surgery and anesthesia. The scale is arbitrary and ranges from 0 (extremely poor QoR) to 150 (excellent QoR). |
Contacts
Primary ContactPo-Han Li
Outcome results
None listed