pMDT in Thoracic Surgery--------For the Baseline Investigation and Technical Preparation Stage

Sponsor
Peking University People's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03759275
Collaborator
Peking Union Medical College Hospital (Other), Anhui Provincial Hospital (Other), Southwest Hospital, China (Other), Fujian Provincial Hospital (Other), Hebei Tumor Hospital (Other), Qianfoshan Hospital (Other), General Hospital of Shenyang Military Region (Other), Shanghai Chest Hospital (Other), Zhejiang University (Other), The First Affiliated Hospital of Zhengzhou University (Other), Second Affiliated Hospital of Nanchang University (Other), Guangdong Provincial People's Hospital (Other), First Affiliated Hospital of Xinjiang Medical University (Other), LanZhou University (Other), Second Hospital of Lanzhou University (Other), Kunming General Hospital of PLA (Other), Renmin Hospital of Wuhan University (Other), Henan Provincial People's Hospital (Other), The First Affiliated Hospital of Kunming Medical College (Other), The People's Hospital of Gaozhou (Other), Shanxi Provincial People's Hospital (Other), Liaoning Tumor Hospital & Institute (Other), First Affiliated Hospital of Chongqing Medical University (Other), Hebei Medical University Fourth Hospital (Other)
480
1
36
13.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: pMDT(Baseline Investigation)

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 Design

Study Type:
Observational
Actual Enrollment :
480 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date :
Sep 1, 2018
Actual Primary Completion Date :
Aug 31, 2019
Actual Study Completion Date :
Aug 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Stage 1

For the Baseline Investigation and Technical Preparation Stage

Other: pMDT(Baseline Investigation)
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.

Outcome Measures

Primary Outcome Measures

  1. Incidence rate of postoperative pain [Up to 90 days after surgery.]

    The percentage of patients with NRS score greater than 3

  2. The degree of patients' satisfaction [3 days after surgery.]

    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).

Secondary Outcome Measures

  1. Postoperative duration of stay in hospital [Up to 90 days after surgery.]

    The duration when patients stay in hospital after surgery.

  2. Rehospitalization rate [Up to 90 days after surgery.]

    The percentage of patients who are rehospitalized.

  3. Postoperative complication incidence rate [Up to 90 days after surgery.]

    The percentage of patients with complications after surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University People's Hospital Beijing Beijing China 100044

Sponsors and Collaborators

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

Investigators

  • Study Director: Feng Yi, Peking University People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yi Feng, MD, Director of department of anesthesiology and pain management, Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT03759275
Other Study ID Numbers:
  • 2018PHB053-01
First Posted:
Nov 29, 2018
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yi Feng, MD, Director of department of anesthesiology and pain management, Peking University People's Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 29, 2022