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NCT Number: NCT04578483

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 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.

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

China Medical University Hsinchu Hospital

Hsinchu, 302, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

ERDS group

Other

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

Primary outcomes

  1. Postoperative pain intensity (numerical rating scale)

    Time frame: 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 outcomes

  1. Consumption of anesthetics

    Time frame: From Day 0 to Day 5

    Amounts of medicines used during surgery are all analyzed, especially the ones related to analgesia.

  2. Consumption of analgesics

    Time frame: From Day 0 to Day 5

    Amounts of opioids are converted into morphine equivalents. Amounts of NSAIDs are calculated separately.

  3. Adverse events

    Time frame: From Day 0 to Day 5

    Percentage of the population suffering from postoperative adverse events are analyzed, especially the ones related to analgesics.

  4. EQ-5D-5L score

    Time frame: 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.

  5. Patient satisfaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 8, 2020
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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