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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04578483
Other study ID # CMUH109-REC3-101
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 26, 2020
Est. completion date December 31, 2021

Study information

Verified date October 2020
Source China Medical University Hospital
Contact Kee-Ming Man, MD, MS
Phone +886-3-5580-558
Email man.jimmy60@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date December 31, 2021
Est. primary completion date December 15, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

1. Aged 20 to 80.

2. Needing pain management after elective surgery.

3. American Society of Anesthesiology Physical Class (ASA) between 1 and 3.

Exclusion Criteria:

1. Allergic to anesthetics, opioids, or medicine used during study period.

2. Severe comorbidity, such as cardiopulmonary disease and strock.

3. Abuse or long-term use of opioids.

4. Pregnant or breastfeeding.

5. Judged to be unsuitable subjects by investigator.

Study Design


Related Conditions & MeSH terms


Intervention

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.
ERDS group
After anesthesia, extended-release dinalbuphine sebacate (ERDS) is injected into gluteus maximus with ultrasound guidance.

Locations

Country Name City State
Taiwan China Medical University Hsinchu Hospital Hsinchu

Sponsors (1)

Lead Sponsor Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Consumption of anesthetics Amounts of medicines used during surgery are all analyzed, especially the ones related to analgesia. From Day 0 to Day 5
Secondary Consumption of analgesics Amounts of opioids are converted into morphine equivalents. Amounts of NSAIDs are calculated separately. From Day 0 to Day 5
Secondary 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
Secondary 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
Secondary 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
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