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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04578483
• Other study ID #: CMUH109-REC3-101
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

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