pMDT in Thoracic Surgery--The Process Implementation Stage

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

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 Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Combination product: pMDT(Process Implementation)

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: Observational
• Enrollment (Actual): 480

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing thoracic surgery in Peking University People's Hospital and other multi-centers.

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?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Stage 2; The Process Implementation Stage

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative duration of stay in hospital	The duration when patients stay in hospital after surgery.	Up to 90 days after surgery.
Rehospitalization rate	The percentage of patients who are rehospitalized.	Up to 90 days after surgery.
Postoperative complication incidence rate	The percentage of patients with complications after surgery.	Up to 90 days after surgery.

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: General Hospital of Shenyang Military Region; LanZhou University; Peking Union Medical College Hospital; Southwest Hospital, China; The First Affiliated Hospital of Zhengzhou University; Guangdong Provincial People's Hospital; Shanghai Chest Hospital; Shaanxi Provincial People's Hospital; Henan Provincial People's Hospital; Qianfoshan Hospital; Hebei Medical University Fourth Hospital; Renmin Hospital of Wuhan University; Zhejiang University; The First Affiliated Hospital of Kunming Medical College; First Affiliated Hospital of Xinjiang Medical University; Second Affiliated Hospital of Nanchang University; Liaoning Tumor Hospital & Institute; First Affiliated Hospital of Chongqing Medical University; Fujian Provincial Hospital; Anhui Provincial Hospital; Second Hospital of Lanzhou University; Hebei Tumor Hospital; The People's Hospital of Gaozhou; Kunming General Hospital of PLA
• Investigators: Study Director: Feng Yi, MD, 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): December 1, 2018
• Primary Completion (ACTUAL): August 31, 2021
• Study Completion (ACTUAL): August 31, 2021

Study Registration Dates

• First Submitted: November 30, 2018
• First Submitted That Met QC Criteria: November 30, 2018
• First Posted (ACTUAL): December 3, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 27, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Thoracic surgery; pMDT
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2018PHB054-01

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