pMDT in Thoracic Surgery--The Process Implementation Stage

Pain, Postoperative Clinical Trial

Official title:

Perioperative Pain Management With Multi-discipline Team(pMDT) in Thoracic Surgery: a Multi-center，Prospective, Observational Study--The Process Implementation Stage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03761550
• Other study ID #: 2018PHB054-01
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: August 31, 2021

Study information

• Verified date: March 2022
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Combination Product:
• pMDT(Process Implementation)
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.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (25)

Lead Sponsor

Collaborator

Peking University People's Hospital

Anhui Provincial Hospital, First Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Xinjiang Medical University, Fujian Provincial Hospital, General Hospital of Shenyang Military Region, Guangdong Provincial People's Hospital, Hebei Medical University Fourth Hospital, Hebei Tumor Hospital, Henan Provincial People's Hospital, Kunming General Hospital of PLA, LanZhou University, Liaoning Tumor Hospital & Institute, Peking Union Medical College Hospital, Qianfoshan Hospital, Renmin Hospital of Wuhan University, Second Affiliated Hospital of Nanchang University, Second Hospital of Lanzhou University, Shaanxi Provincial People's Hospital, Shanghai Chest Hospital, Southwest Hospital, China, The First Affiliated Hospital of Kunming Medical College, The First Affiliated Hospital of Zhengzhou University, The People's Hospital of Gaozhou, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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

Sharp HT. Management of Postoperative Abdominal Wall Pain. Clin Obstet Gynecol. 2015 Dec;58(4):798-804. doi: 10.1097/GRF.0000000000000152. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of postoperative pain	The percentage of patients with numerical rating scale(NRS)score greater than 3. The NRS score is ranged from 0 to 10. 0 means without pain. 1-3 means mild pain. 4-6 means moderate pain. 7-9 means severe pain. 10 means intense pain and can't bear.	Up to 90 days after surgery.
Primary	The degree of patients' satisfaction	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).	3 days after surgery.
Secondary	Postoperative duration of stay in hospital	The duration when patients stay in hospital after surgery.	Up to 90 days after surgery.
Secondary	Rehospitalization rate	The percentage of patients who are rehospitalized.	Up to 90 days after surgery.
Secondary	Postoperative complication incidence rate	The percentage of patients with complications after surgery.	Up to 90 days after surgery.