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Postoperative Pain, AcuteNCT05884021

Effectiveness of Pain Control and Adverse Reactions After Intravenous PCA in Chinese Population

An observational study of Postoperative Pain, Acute, run by Huazhong University of Science and Technology.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Postoperative Pain, Acute
What is being tested?
Postoperative analgesia
Type of treatment
Injection or infusion
How many people
40,000 participants
Where
No sites listed yet
Study dates
1 Jan 2016to 31 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

About this study

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.
Read the 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.

Being tested
Postoperative analgesia
Keywords
postoperative pain, acute pain service, poor postoperative analgesia, postoperative nausea and vomitting
Medical subject headings
Pain, Postoperative, Postoperative Nausea and Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Postoperative analgesiaOther

    In patients who used intravenous PCA after surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Poor postoperative analgesia

    Incidence of poor postoperative analgesia

    Measured: 2016-2021

Secondary outcomes (1)

  1. Incidence of adverse effects of postoperative analgesia

    Incidence of adverse effects of postoperative analgesia, especially postoperative nausea and vomiting

    Measured: 2016-2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2023
  2. Study start1 Jan 2016
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
40,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05884021
Sponsor's protocol ID
postoperative pain
Status last verified
May 2023
First submitted
22 May 2023
Last updated
1 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 26313057

  • 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.

    PubMed 33649338

  • 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.

    PubMed 12873949

  • 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.

    PubMed 18417292

  • 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.

    PubMed 29738328

  • 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.

    PubMed 30983589

  • Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.

    PubMed 26509324

  • 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.

    PubMed 30113942

  • 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.

    PubMed 23392233

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Pain, Acute, run by Huazhong University of Science and Technology.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Poor postoperative analgesia (time frame: 2016-2021). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05884021, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.

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