NCT03761550

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

2.8 years

First QC Date

November 30, 2018

Last Update Submit

March 27, 2022

Conditions

Pain, Postoperative

Keywords

pMDTPainThoracic surgery

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Postoperative duration of stay in hospital

    Up to 90 days after surgery.

  • Rehospitalization rate

    Up to 90 days after surgery.

  • Postoperative complication incidence rate

    Up to 90 days after surgery.

Study Arms (1)

Stage 2

The Process Implementation Stage

Combination Product: pMDT(Process Implementation)

Interventions

pMDT(Process Implementation)COMBINATION_PRODUCT

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.

Stage 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Related 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.

    PMID: 26329661BACKGROUND

  • 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.

    PMID: 26213198BACKGROUND

  • 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.

    PMID: 25890623BACKGROUND

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

    PMID: 26512441BACKGROUND

  • 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.

    PMID: 26600464BACKGROUND

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

    PMID: 26509324BACKGROUND

  • 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.

    PMID: 25987449BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativePain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Feng Yi, MD

    Peking University People's Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of department of anesthesiology and pain management

Study Record Dates

First Submitted

November 30, 2018

First Posted

December 3, 2018

Study Start

December 1, 2018

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

March 29, 2022

Record last verified: 2022-03

Locations

CN(1)