- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03759275
pMDT in Thoracic Surgery--------For the Baseline Investigation and Technical Preparation Stage
Perioperative Pain Management With Multi-discipline Team(pMDT) in Thoracic Surgery: a Multi-center,Prospective, Observational Study--------For the Baseline Investigation and Technical Preparation Stage
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The postoperative acute pain refers to the acute pain (usually lasting less than 7 days) that occurs immediately after surgery, and its nature is traumatic pain. It may develop into a chronic pain, such as a neuropathic pain or a mixed pain, if it is not fully controlled at the initial state. It will seriously impact the physiology and psychology of a patient. According to the study, the postoperative acute pain is one of the risks for postoperative complications, and it may result in the death of a patient. However, the alleviation of a postoperative acute pain can shorten the duration of stay in hospital, and reduce the overall cost for treatment of a patient.
The risk of acute and chronic pain after thoracic surgery is high. The multi-disciplinary postoperative pain management strategy is the best way to control postoperative pain in thoracic surgery. Through nearly one year of experience in implementation of the pMDT in the thoracic surgery department of Peking University People's Hospital, the investigators have summarized the experience in multidisciplinary pain management and promoted this study in multi-centers across the country, hoping that this study can improve the current situation of acute pain management in patients after thoracic surgery, and at the same time, the deficiencies of this clinical protocol can be found out and improved.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100044
- Peking University People's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged between 18 and 75, ASA I-II;
- Patients undergoing thoracoscopic surgery;
- Patients who can understand and fill in the self-evaluation;
- Patients who signed the Informed Consent Form.
Exclusion Criteria:
- Pregnant women;
- Patients with preoperative chronic pain and long-term opioid use;
- Patients with advanced tumors who have received preoperative chemotherapy or who are expected to receive postoperative chemotherapy.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Stage 1
For the Baseline Investigation and Technical Preparation Stage
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The pMDT(Baseline Investigation) takes multi-model analgesia as the main technical means.
Multimodal perioperative analgesia refers to the combination of analgesics, adjuvant drugs and analgesic techniques with different effects throughout the perioperative period to achieve the best curative effect of reducing postoperative acute and chronic pain.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The degree of patients' satisfaction
Time Frame: 3 days after surgery.
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The degree of patients' satisfaction on pain managements.
Patients were asked to give a score from 0-10 (0 means dissatisfied, 10 means very satisfied).
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3 days after surgery.
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Incidence rate of postoperative pain
Time Frame: Up to 90 days after surgery.
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The percentage of patients with NRS score greater than 3
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Up to 90 days after surgery.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative duration of stay in hospital
Time Frame: Up to 90 days after surgery.
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The duration when patients stay in hospital after surgery.
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Up to 90 days after surgery.
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Rehospitalization rate
Time Frame: Up to 90 days after surgery.
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The percentage of patients who are rehospitalized.
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Up to 90 days after surgery.
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Postoperative complication incidence rate
Time Frame: Up to 90 days after surgery.
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The percentage of patients with complications after surgery.
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Up to 90 days after surgery.
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Feng Yi, Peking University People's Hospital
Publications and helpful links
General Publications
- Bugada D, Lavand'homme P, Ambrosoli AL, Klersy C, Braschi A, Fanelli G, Saccani Jotti GM, Allegri M; SIMPAR group. Effect of postoperative analgesia on acute and persistent postherniotomy pain: a randomized study. J Clin Anesth. 2015 Dec;27(8):658-64. doi: 10.1016/j.jclinane.2015.06.008. Epub 2015 Aug 30.
- Kelley BP, Shauver MJ, Chung KC. Management of Acute Postoperative Pain in Hand Surgery: A Systematic Review. J Hand Surg Am. 2015 Aug;40(8):1610-9, 1619.e1. doi: 10.1016/j.jhsa.2015.05.024.
- Lesin M, Domazet Bugarin J, Puljak L. Factors associated with postoperative pain and analgesic consumption in ophthalmic surgery: a systematic review. Surv Ophthalmol. 2015 May-Jun;60(3):196-203. doi: 10.1016/j.survophthal.2014.10.003. Epub 2014 Nov 5.
- Sharp HT. Management of Postoperative Abdominal Wall Pain. Clin Obstet Gynecol. 2015 Dec;58(4):798-804. doi: 10.1097/GRF.0000000000000152.
- Pogatzki-Zahn E, Kutschar P, Nestler N, Osterbrink J. A Prospective Multicentre Study to Improve Postoperative Pain: Identification of Potentialities and Problems. PLoS One. 2015 Nov 24;10(11):e0143508. doi: 10.1371/journal.pone.0143508. eCollection 2015.
- Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
- Yun XD, Yin XL, Jiang J, Teng YJ, Dong HT, An LP, Xia YY. Local infiltration analgesia versus femoral nerve block in total knee arthroplasty: a meta-analysis. Orthop Traumatol Surg Res. 2015 Sep;101(5):565-9. doi: 10.1016/j.otsr.2015.03.015. Epub 2015 May 16.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018PHB053-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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