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

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Other: PCA group; Other: ERDS group

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Kee-Ming Man, MD, MS; Phone Number: 1371 +886-3-5580-558; Email: man.jimmy60@gmail.com

Study Locations

• Taiwan
  • Hsinchu, Taiwan, 302
    • China Medical University Hsinchu Hospital
    • Contact: Kee-Ming Man, MD, MS; Phone Number: 1371 +886 3 5580558; Email: man.jimmy60@gmail.com
    • Principal Investigator: Kee-Ming Man, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients having elective surgery in China Medical University Hsinchu Hospital were invited to participate in this study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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.
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.
PRN group; Patients receiving analgesics other than ERDS and PCA will be allocated to PRN group.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: Kee-Ming Man, MD, MS, China Medical University Hsinchu Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 26, 2020
• Primary Completion (ANTICIPATED): December 15, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (ACTUAL): October 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Postoperative Pain; Dinalbuphine sebacate; PCA; Analgesia; Analgesics; Extended-release; Naldebain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: CMUH109-REC3-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No