- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05884021
Effectiveness of Pain Control and Adverse Reactions After Intravenous PCA in Chinese Population
May 22, 2023 updated by: Xianwei Zhang,MD, Huazhong University of Science and Technology
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:
- 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;
- 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
40000
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Poor postoperative analgesia
Time Frame: 2016-2021
|
Incidence of poor postoperative analgesia
|
2016-2021
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse effects of postoperative analgesia
Time Frame: 2016-2021
|
Incidence of adverse effects of postoperative analgesia, especially postoperative nausea and vomiting
|
2016-2021
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xianwei Zhang, Doctor, Huazhong University of Science and Technology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
May 22, 2023
First Submitted That Met QC Criteria
May 22, 2023
First Posted (Actual)
June 1, 2023
Study Record Updates
Last Update Posted (Actual)
June 1, 2023
Last Update Submitted That Met QC Criteria
May 22, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- postoperative pain
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Pain, Acute
-
Schulthess KlinikNot yet recruiting
-
Seoul National University HospitalNot yet recruiting
-
Chung-Ang University Gwangmyeong HospitalRecruitingPostoperative Pain, AcuteKorea, Republic of
-
TC Erciyes UniversityCompletedPostoperative Pain, AcuteTurkey
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Ankara City Hospital BilkentRecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | SternotomyTurkey
-
Umraniye Education and Research HospitalNot yet recruiting
-
Sohag UniversityCompletedPostoperative Pain, AcuteEgypt
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
Clinical Trials on Postoperative analgesia
-
Taipei City HospitalCompletedPain, Postoperative | Epidural Anesthesia | Lumbar Spine Degeneration | Analgesia, Patient-ControlledTaiwan
-
The Institute of Molecular and Translational Medicine...Brno University Hospital; Tomas Bata Hospital, Czech RepublicCompletedColon Cancer | Minimal Residual DiseaseCzechia
-
Colorado State UniversityU.S. Highbush Blueberry CouncilCompletedHypertension | Menopause | Endothelial Dysfunction | Elevated Blood PressureUnited States
-
Yonsei UniversityRecruitingResectable Pancreatic AdenocarcinomaKorea, Republic of
-
University of North Carolina, Chapel HillNorth Carolina Spine SocietyTerminated
-
Bursa City HospitalRecruiting
-
Mursel EkinciCompletedKnee Osteoarthritis | Knee Arthritis | Knee DiseaseTurkey
-
GenfitCompletedLiver Diseases | Moderate Hepatic Impairment | Severe Hepatic ImpairmentUnited States
-
Tanta UniversityNot yet recruitingBariatric Surgery Candidate
-
Medipol UniversityRecruiting