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

NCT ID: NCT04578483

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

634 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-27

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

ERDS group

Intervention Type OTHER

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

Interventions

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ERDS group

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kee-Ming Man

Director, Department of Anesthesiology, China Medical University Hsinchu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kee-Ming Man, MD, MS

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hsinchu Hospital

Locations

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China Medical University Hsinchu Hospital

Hsinchu, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CMUH109-REC3-101

Identifier Type: -

Identifier Source: org_study_id

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