Postoperative Pain Management of Therapeutic Surgery: a Prospective, Observational Cohort Study.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| PCA group Patients receiving patient-controlled analgesia (PCA) will be allocated to PCA group. |
Other: PCA group
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.
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| ERDS group Patients receiving one dose of extended-release dinalbuphine sebacate (ERDS) by ultrasound-guided muscle injection will be allocated to ERDS group. |
Other: ERDS group
After anesthesia, extended-release dinalbuphine sebacate (ERDS) is injected into gluteus maximus with ultrasound guidance.
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| PRN group Patients receiving analgesics other than ERDS and PCA will be allocated to PRN group. |
Outcome Measures
Primary Outcome Measures
- Postoperative pain intensity (numerical rating scale) [From Day 0 to Day 5]
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).
Secondary Outcome Measures
- Consumption of anesthetics [From Day 0 to Day 5]
Amounts of medicines used during surgery are all analyzed, especially the ones related to analgesia.
- Consumption of analgesics [From Day 0 to Day 5]
Amounts of opioids are converted into morphine equivalents. Amounts of NSAIDs are calculated separately.
- Adverse events [From Day 0 to Day 5]
Percentage of the population suffering from postoperative adverse events are analyzed, especially the ones related to analgesics.
- EQ-5D-5L score [Within 16 weeks after surgery]
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.
- Patient satisfaction [Within 5 days after surgery]
Before discharge, patients are asked to rate satisfaction toward postoperative pain management on a 5-point scale: very satisfied, satisfied, uncertain, dissatisfied, very dissatisfied.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged 20 to 80.
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Needing pain management after elective surgery.
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American Society of Anesthesiology Physical Class (ASA) between 1 and 3.
Exclusion Criteria:
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Allergic to anesthetics, opioids, or medicine used during study period.
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Severe comorbidity, such as cardiopulmonary disease and strock.
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Abuse or long-term use of opioids.
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Pregnant or breastfeeding.
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Judged to be unsuitable subjects by investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | China Medical University Hsinchu Hospital | Hsinchu | Taiwan | 302 |
Sponsors and Collaborators
- China Medical University Hospital
Investigators
- Principal Investigator: Kee-Ming Man, MD, MS, China Medical University Hsinchu Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CMUH109-REC3-101