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

NCT04578483 | Completed

• 1 other identifier: CMUH109-REC3-101
• Study Type: observational
• Target: 634
• Locations: 1 country
• Sites: 1

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 effect of dinalbuphine sebacate, a long-acting analgesic, in postoperative pain management. This real world data can serve as a reference toward high health care quality.

Conditions

Postoperative Pain

Keywords

Postoperative Pain; Analgesics; Analgesia; Dinalbuphine sebacate; Naldebain; PCA; Extended-release

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Consumption of anesthetics

  From Day 0 to Day 5

• Consumption of analgesics

  From Day 0 to Day 5

• Adverse events

  From Day 0 to Day 5

• EQ-5D-5L score

  Within 16 weeks after surgery

• Patient satisfaction

  Within 5 days after surgery

Study Arms (1)

ERDS group

Patients receiving one dose of extended-release dinalbuphine sebacate (ERDS) by ultrasound-guided muscle injection will be invited to participate in this study.

Other: ERDS group

Interventions

ERDS group OTHER

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

ERDS group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Aged 20 to 80.
• Needing pain management after elective surgery.
• American Society of Anesthesiology Physical Class (ASA) between 1 and 3.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hsinchu Hospital

Hsinchu, 302, Taiwan

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Kee-Ming Man, MD, MS

  China Medical University Hsinchu Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 16 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Anesthesiology, China Medical University Hsinchu Hospital

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 8, 2020
• Study Start: October 27, 2020
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

TW (1)