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Poor management of post-operative acute pain can contribute to medical complications including pneumonia, deep vein thrombosis, infection and delayed healing, as well as the development of chronic. In contrast, appropriate pain control is capable of reducing the postoperative complications, preventing the development of chronic pain, and improving the quality of life. The workloads of medical staffs and health care cost are subsequently decreased. Recently, a lot of analgesic methods have been developed and used in clinical practice, such as patient-controlled analgesia, ultrasound-guided long-term analgesia and multimodal analgesia. This study is aimed to investigate the effect of dinalbuphine sebacate, a long-acting analgesic, in postoperative pain management. This real world data can serve as a reference toward high health care quality.
This is a prospective, observational, cohort study. Patients undergoing elective surgery will be invited to the study. The written informed consent will be obtained prior to participation. Demographic data, underlying condition, surgical procedures, consumption of anesthetics and analgesics, analgesic methods, postoperative complications, pain intensity and life quality will be collected from medical history and by questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERDS group | Patients receiving one dose of extended-release dinalbuphine sebacate (ERDS) by ultrasound-guided muscle injection will be invited to participate in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERDS group | Other | After anesthesia, extended-release dinalbuphine sebacate (ERDS) is injected into gluteus maximus with ultrasound guidance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain intensity (numerical rating scale) | Numerical rating scale (NRS) is used to assess pain intensity from surgical day (Day 0) to five days after surgery (Day 5). NRS is a 11-point scale which labeled from zero (no pain) to ten (worst pain). | From Day 0 to Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Consumption of anesthetics | Amounts of medicines used during surgery are all analyzed, especially the ones related to analgesia. | From Day 0 to Day 5 |
| Consumption of analgesics | Amounts of opioids are converted into morphine equivalents. Amounts of NSAIDs are calculated separately. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients having elective surgery in China Medical University Hsinchu Hospital were invited to participate in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Kee-Ming Man, MD, MS | China Medical University Hsinchu Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hsinchu Hospital | Hsinchu | 302 | Taiwan |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| From Day 0 to Day 5 |
| Adverse events | Percentage of the population suffering from postoperative adverse events are analyzed, especially the ones related to analgesics. | From Day 0 to Day 5 |
| EQ-5D-5L score | EQ-5D-5L questionnaire is used to assess patients' life quality. Patients are asked to fill in the questionnaire prior to surgery, before discharge and/or three months after surgery. | Within 16 weeks after surgery |
| Patient satisfaction | Before discharge, patients are asked to rate satisfaction toward postoperative pain management on a 5-point scale: very satisfied, satisfied, uncertain, dissatisfied, very dissatisfied. | Within 5 days after surgery |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |