Postoperative Pain Management of Therapeutic Surgery: a Prospective, Observational Cohort Study.

Study Overview
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Brief Summary
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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 outcome of each postoperative analgesic method used in China Medical University Hsinchu Hospital. This real world data can serve as a reference toward high health care quality.

Detailed Description
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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.

Official Title
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Postoperative Pain Management of Therapeutic Surgery: a Prospective, Observational Cohort Study.

Conditions
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Postoperative Pain

Intervention / Treatment
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* Other: PCA group
* Other: ERDS group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 20 to 80. Needing pain management after elective surgery. American Society of Anesthesiology Physical Class (ASA) between 1 and 3. Exclusion Criteria: Allergic to anesthetics, opioids, or medicine used during study period. Severe comorbidity, such as cardiopulmonary disease and strock. Abuse or long-term use of opioids. Pregnant or breastfeeding. Judged to be unsuitable subjects by investigator.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCA group<br>Patients receiving patient-controlled analgesia (PCA) will be allocated to PCA group. | Other: PCA group<br>* Patients receiving PCA are allocated in PCA group despite the route of administration. Intravenous PCA is commonly used with morphine or fentanyl while epidural PCA is used with ropivacaine and/or fentanyl frequently.<br>|
| ERDS group<br>Patients receiving one dose of extended-release dinalbuphine sebacate (ERDS) by ultrasound-guided muscle injection will be allocated to ERDS group. | Other: ERDS group<br>* After anesthesia, extended-release dinalbuphine sebacate (ERDS) is injected into gluteus maximus with ultrasound guidance.<br>|
| PRN group<br>Patients receiving analgesics other than ERDS and PCA will be allocated to PRN group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Pain, Analgesics, Analgesia, Dinalbuphine sebacate, Naldebain, PCA, Extended-release