Post Surgical Pain Clinical Trial
— HRQoLOfficial title:
Patient-reported Outcomes of Postsurgical Pain and Health Related Quality of Life, a Multi-centered, Prospective, Observational, Cohort Study
NCT number | NCT03926858 |
Other study ID # | 2018PHB229-01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 12, 2019 |
Est. completion date | May 8, 2023 |
Verified date | June 2024 |
Source | Peking University People's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will investigate the impact of post-surgical pain (PSP) on health related quality of life (HRQoL) within the first six months following surgery using patient-reported outcome (PRO) measures, and to investigate medical recovery measures such as ambulation and oral feeding time as secondary outcomes.
Status | Completed |
Enrollment | 2000 |
Est. completion date | May 8, 2023 |
Est. primary completion date | May 8, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years or older - Undergoing general or regional anesthesia - Hospitalized for at least 24 hours after surgery Exclusion Criteria: - Existing diagnoses of psychiatric pathology - Surgery cancellation - Unable to give informed consent - Unable to read and write |
Country | Name | City | State |
---|---|---|---|
China | The Affiliated Hospital of Inner Mongolia Medical University | Baotou | Inner Mongolia |
China | Peking University People's Hospital | Beijing | Beijing |
China | Xiyuan Hospital | Beijing | |
China | The First Hospital of Changsha | Changsha | Hunan |
China | The Third Xiangya Hospital of Central South University | Changsha | Hunan |
China | West China Hospital | Chengdu | Sichuan |
China | The Ninth People's Hospital of Chongqing | Chongqing | |
China | Hangzhou Red Cross Hospital | Hangzhou | Zhejiang |
China | Tongde Hospital of Zhejiang Province | Hangzhou | Zhejiang |
China | Huhhot First Hospital | Hohhot | Inner Mongolia |
China | The First People's Hospital of Liangshan Yi Autonomous Prefecture | Liangshan | Yunan |
China | The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi |
China | Nanjing First Hospital | Nanyang | Jiangsu |
China | Huadong Hospital Affiliated to Fudan University | Shanghai | |
China | Songyuan Central Hospital | Songyuan | Jilin |
China | Shanxi Provincial People's Hospital | Taiyuan | Shanxi |
China | The Second Hospital of Tianjin Medical University | Tianjin | |
China | First Affiliated Hospital of Xinjiang Medical University | Urumqi | Xinjiang |
China | The Third People's Hospital of Hubei Province | Wuhan | Hubei |
China | Tongji Hospital | Wuhan | Hubei |
China | Xingtai People's Hospital | Xingtai | Hebei |
China | People's Hospital of Yuxi | Yuxi | Yunnan |
China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Peking University People's Hospital |
China,
Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014 Jan;30(1):149-60. doi: 10.1185/03007995.2013.860019. Epub 2013 Nov 15. — View Citation
Taylor RS, Ullrich K, Regan S, Broussard C, Schwenkglenks M, Taylor RJ, Gordon DB, Zaslansky R, Meissner W, Rothaug J, Langford R; PAIN-OUT investigators. The impact of early postoperative pain on health-related quality of life. Pain Pract. 2013 Sep;13(7):515-23. doi: 10.1111/papr.12026. Epub 2012 Dec 23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Health related quality of life(HRQoL) | HRQoL is measured with EuroQol five-dimensional questionnaire(EQ-5D). | up to 6 months after surgery | |
Primary | Pain after surgery | Postsurgical pain is measured with the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) . | up to 6 months after surgery | |
Secondary | ambulation time | the first time when patients can get off of bed and walk after surgery | up to 30 days after surgery | |
Secondary | oral feeding time | the first time when patients begin oral feeding after surgery | up to 30 days after surgery |
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