Pain, PostoperativeNCT03761550
pMDT in Thoracic Surgery--The Process Implementation Stage
An observational study of Pain, Postoperative, run by Peking University People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- pMDT(Process Implementation)
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing thoracic surgery in Peking University People's Hospital and other multi-centers.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- pMDT(Process Implementation)
- Keywords
- pMDT, Pain, Thoracic surgery
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Stage 2 | The Process Implementation Stage Receives: Combination Product: pMDT(Process Implementation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 3 days after surgery.
Secondary outcomes (3)
Postoperative duration of stay in hospital
The duration when patients stay in hospital after surgery.
Measured: Up to 90 days after surgery.
Rehospitalization rate
The percentage of patients who are rehospitalized.
Measured: Up to 90 days after surgery.
Postoperative complication incidence rate
The percentage of patients with complications after surgery.
Measured: Up to 90 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start1 Dec 2018
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- 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, Lanzhou University Second Hospital, Kunming General Hospital of PLA, Renmin Hospital of Wuhan University, Henan Provincial People's Hospital, First Affiliated Hospital of Kunming Medical University, The People's Hospital of Gaozhou, Shaanxi Provincial People's Hospital, Liaoning Cancer Hospital & Institute, First Affiliated Hospital of Chongqing Medical University, Hebei Medical University Fourth Hospital
- Responsible party
- Principal investigator, Yi Feng, MD, Peking University People's Hospital
- Investigators
- Feng Yi, MD, Study director, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761550
- Sponsor's protocol ID
- 2018PHB054-01
- Status last verified
- Mar 2022
- First submitted
- 30 Nov 2018
- Last updated
- 29 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 26329661Kelley 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.
PubMed 26213198Lesin 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.
PubMed 25890623Sharp HT. Management of Postoperative Abdominal Wall Pain. Clin Obstet Gynecol. 2015 Dec;58(4):798-804. doi: 10.1097/GRF.0000000000000152.
PubMed 26512441Pogatzki-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.
PubMed 26600464Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
PubMed 26509324Yun 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.
PubMed 25987449
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Pain Management With Multi-discipline Team(pMDT) in Thoracic Surgery: a Multi-center，Prospective, Observational Study--The Process Implementation Stage
- ClinicalTrials.gov ID
- NCT03761550
- Acronym / sponsor ID
- 2018PHB054-01
- Conditions
- Pain, Postoperative
- Keywords
- pMDT, Pain, Thoracic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- 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, Lanzhou University Second Hospital, Kunming General Hospital of PLA, Renmin Hospital of Wuhan University, Henan Provincial People's Hospital, First Affiliated Hospital of Kunming Medical University, The People's Hospital of Gaozhou, Shaanxi Provincial People's Hospital, Liaoning Cancer Hospital & Institute, First Affiliated Hospital of Chongqing Medical University, Hebei Medical University Fourth Hospital
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage 2 | – | Combination Product: pMDT(Process Implementation)The Process Implementation Stage |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing thoracic surgery in Peking University People's Hospital and other multi-centers.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | Stage 2 |
Primary outcome
Incidence rate of postoperative pain
Time frame: Up to 90 days after surgery.
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.
The degree of patients' satisfaction
Time frame: 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).
3 secondary outcomes
Postoperative duration of stay in hospital
Time frame: Up to 90 days after surgery.
Rehospitalization rate
Time frame: Up to 90 days after surgery.
Postoperative complication incidence rate
Time frame: Up to 90 days after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Background: PubMed 26329661Bugada 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.
- Background: PubMed 26213198Kelley 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.
- Background: PubMed 25890623Lesin 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.
- Background: PubMed 26512441Sharp HT. Management of Postoperative Abdominal Wall Pain. Clin Obstet Gynecol. 2015 Dec;58(4):798-804. doi: 10.1097/GRF.0000000000000152.
- Background: PubMed 26600464Pogatzki-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.
- Background: PubMed 26509324Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
- Background: PubMed 25987449Yun 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng Yi, MD study director
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of postoperative pain (time frame: Up to 90 days after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03761550, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.