Clinical trial NCT05884021: Effectiveness of Pain Control and Adverse Reactions After Intravenous PCA in Chinese Population
Official title: Effectiveness of Pain Control and Adverse Reactions After Intravenous PCA in Chinese Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain, Acute
Keywords: postoperative pain
acute pain service
poor postoperative analgesia
postoperative nausea and vomitting
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 40000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The surgical patients in Tongji Hospital (Central Operating Room of Hankou Hospital) affiliated to Tongji Medical College of Huazhong University of Science and Technology from January 2016 to December 2021

Brief summary: Here, we retrospectively analyzed the proportion of intravenous patient controlled analgesia (PCA) used in a large tertiary hospital in central China, and then further analyzed the proportion of patients with postoperative pain after standardized pain treatment and the incidence of adverse effects. It aims to answer are:

1. The incidence of poor postoperative analgesia and adverse effects of patients with different types of surgery after standardized postoperative pain management of TJ-APS team;
2. It would provide reference for improving the quality of postoperative acute pain management. In addition, it supplements the Chinese data on the incidence of poor postoperative analgesia and adverse effects of patients under the APS standardized postoperative analgesia process.

Detailed description: Acute pain service (APS) is an important management mode to improve postoperative acute pain, and it has been widely used in hospitals around the world for many years. According to a survey, more than 60% of hospitals in Europe and America have APS teams. Most of the information on postoperative pain management is mainly based on the research performed in United States, Germany and other European countries. Moreover, the current clinical research on postoperative analgesia is mainly focused on improving analgesia technology and drugs, while there are few studies on the impact of postoperative pain management (such as APS) on the prognosis of patients, especially the research on large samples. Considering that China's population accounts for about 21.5% of the world's population, the United States accounts for about 4.3% of the world's population, and Germany accounts for about 1%. Therefore, it is necessary to study the current situation of analgesia in China, especially the poor postoperative analgesia and adverse effects after different types of surgery in Chinese patients. The 27th National Anesthesia Academic Annual Meeting in 2019 reported that only 25.12% of hospitals in China have established APS or similar groups, and only 23.48% provided pain treatment education before surgery, and less than 10% of them are responsible for the whole process of postoperative analgesia services.

Eligibility criteria: Inclusion Criteria:

* The surgical patients in Tongji Hospital (Central Operating Room of Hankou Hospital) affiliated to Tongji Medical College of Huazhong University of Science and Technology from January 2016 to December 2021

Exclusion Criteria:

* Some cases with incomplete patient information records and incomplete patient follow-up data records due to human factors were excluded.

Primary outcomes:
measure: Poor postoperative analgesia
timeFrame: 2016-2021
Secondary outcomes:
measure: Incidence of adverse effects of postoperative analgesia
timeFrame: 2016-2021
Other outcomes:
Locations:
Study officials:
affiliation: Huazhong University of Science and Technology
name: Xianwei Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weiser TG, Haynes AB, Molina G, Lipsitz SR, Esquivel MM, Uribe-Leitz T, Fu R, Azad T, Chao TE, Berry WR, Gawande AA. Estimate of the global volume of surgery in 2012: an assessment supporting improved health outcomes. Lancet. 2015 Apr 27;385 Suppl 2:S11. doi: 10.1016/S0140-6736(15)60806-6. Epub 2015 Apr 26.
citation: Brigham NC, Ji RR, Becker ML. Degradable polymeric vehicles for postoperative pain management. Nat Commun. 2021 Mar 1;12(1):1367. doi: 10.1038/s41467-021-21438-3.
citation: Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.
citation: Fletcher D, Fermanian C, Mardaye A, Aegerter P; Pain and regional anesthesia committee of the French Anesthesia and Intensive Care Society (SFAR). A patient-based national survey on postoperative pain management in France reveals significant achievements and persistent challenges. Pain. 2008 Jul 15;137(2):441-451. doi: 10.1016/j.pain.2008.02.026. Epub 2008 Apr 15.
citation: Richebe P, Capdevila X, Rivat C. Persistent Postsurgical Pain: Pathophysiology and Preventative Pharmacologic Considerations. Anesthesiology. 2018 Sep;129(3):590-607. doi: 10.1097/ALN.0000000000002238.
citation: Glare P, Aubrey KR, Myles PS. Transition from acute to chronic pain after surgery. Lancet. 2019 Apr 13;393(10180):1537-1546. doi: 10.1016/S0140-6736(19)30352-6.
citation: Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
citation: Kehlet H. Postoperative pain, analgesia, and recovery-bedfellows that cannot be ignored. Pain. 2018 Sep;159 Suppl 1:S11-S16. doi: 10.1097/j.pain.0000000000001243. No abstract available.
citation: Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.