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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NALDEBAIN | Patients injected with dinalbuphine sebacate intramuscularly will be allocated to NALDEBAIN group. |
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| CONTROL | Patients receiving postoperative pain management without dinalbuphine sebacate will be allocated to CONTROL group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dinalbuphine sebacate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain intensity | 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. | Within 3 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Consumption of analgesics | The mean total consumption of analgesics during the hospital stay after delivery. | Within 7 days after surgery |
| GAD-7 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patient scheduled to have video-assisted thoracoscopic lung tumor resection in China Medical University Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Po-Han Li | Contact | +886-4-22052121 | 12939 | bryan21825114@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hsin-Yuan Fang | China Medical University Hospital | Principal Investigator |
| Po-Han Li | China Medical University Hospital | Principal Investigator |
| Kin-Shing Poon |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Analgesic injectables | Drug | Opioids, NSAIDs or acetamol will be administrated as need. |
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| Enteral analgesics | Drug | Opioids, NSAIDs or acetaminophen will be prescribed if necessary. |
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| At baseline, 7 days and 3 months after surgery |
| QoR-15 | 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). | At baseline, 7 days and 3 months after surgery |
| China Medical University Hospital |
| Principal Investigator |
| Hsiurong Liao | China Medical University Hospital | Principal Investigator |
| Tzu-Min Huang | China Medical University Hospital | Principal Investigator |
| Yu-Cheng Shen | China Medical University Hospital | Principal Investigator |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |