Clinical trial NCT04578483: Postoperative Pain Management of Therapeutic Surgery: a Prospective, Observational Cohort Study.
Official title: Postoperative Pain Management of Therapeutic Surgery: a Prospective, Observational Cohort Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Pain
Keywords: Postoperative Pain
Analgesics
Analgesia
Dinalbuphine sebacate
Naldebain
PCA
Extended-release
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having elective surgery in China Medical University Hsinchu Hospital were invited to participate in this study.

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 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative pain intensity (numerical rating scale)
timeFrame: From Day 0 to Day 5
Secondary outcomes:
measure: Consumption of anesthetics
timeFrame: From Day 0 to Day 5
measure: Consumption of analgesics
timeFrame: From Day 0 to Day 5
measure: Adverse events
timeFrame: From Day 0 to Day 5
measure: EQ-5D-5L score
timeFrame: Within 16 weeks after surgery
measure: Patient satisfaction
timeFrame: Within 5 days after surgery
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: China Medical University Hsinchu Hospital
Study officials:
affiliation: China Medical University Hsinchu Hospital
name: Kee-Ming Man, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: