Patient-reported Outcomes of Postsurgical Pain and Health Related Quality of Life

Post Surgical Pain Clinical Trial

— HRQoL  

Official title:

Patient-reported Outcomes of Postsurgical Pain and Health Related Quality of Life, a Multi-centered, Prospective, Observational, Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03926858
• Other study ID #: 2018PHB229-01
• Status: Recruiting
• Start date: June 12, 2019
• Est. completion date: December 2022

Study information

• Verified date: February 2022
• Source: Peking University People's Hospital
• Contact: Yi Feng, MD, PhD
• Phone: 86-010-88325581
• Email: littlevon[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Pain and recovery after surgery are extremely concerned by patients undergoing surgery. Though it is important to understand the recovery course of postsurgical pain and recovery, most previous studies just focused on one specific time point, and the results were inconsistent. To investigate the impact of PSP on HRQoL within the first six months following surgery using PRO measures, patients undergoing several specific surgeries will be interviewed. Patients' medical charts will be reviewed by investigators to record sociodemographic and clinical data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2022
• Est. primary completion date: November 2022
• 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Surgical Pain

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. Review. — 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

Outcome

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