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

NCT03926858 | Completed DMC

• 1 other identifier: 2018PHB229-01
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 23

Brief 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.

Conditions

Post Surgical Pain

Keywords

post-surgical pain; health-related quality of life

Outcome Measures

Primary Outcomes (2)

• Health related quality of life(HRQoL)

  HRQoL is measured with EuroQol five-dimensional questionnaire(EQ-5D).

  up to 6 months after surgery

• 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 Outcomes (2)

• ambulation time

  up to 30 days after surgery

• oral feeding time

  up to 30 days after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients undergoing the following procedures: breast surgery, thoracic surgery, abdominal surgery, orthopedic surgery.

You may qualify if:

• years or older
• Undergoing general or regional anesthesia
• Hospitalized for at least 24 hours after surgery

You may not qualify if:

• Existing diagnoses of psychiatric pathology
• Surgery cancellation
• Unable to give informed consent
• Unable to read and write

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (23)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Location

Xingtai People's Hospital

Xingtai, Hebei, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

The Third People's Hospital of Hubei Province

Wuhan, Hubei, China

Location

Tongji Hospital

Wuhan, Hubei, China

Location

The First Hospital of Changsha

Changsha, Hunan, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

The Affiliated Hospital of Inner Mongolia Medical University

Baotou, Inner Mongolia, China

Location

Huhhot First Hospital

Hohhot, Inner Mongolia, China

Location

Nanjing First Hospital

Nanyang, Jiangsu, China

Location

Songyuan Central Hospital

Songyuan, Jilin, China

Location

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China

Location

West China Hospital

Chengdu, Sichuan, China

Location

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Location

The First People's Hospital of Liangshan Yi Autonomous Prefecture

Liangshan, Yunan, China

Location

People's Hospital of Yuxi

Yuxi, Yunnan, China

Location

Hangzhou Red Cross Hospital

Hangzhou, Zhejiang, China

Location

Tongde Hospital of Zhejiang Province

Hangzhou, Zhejiang, China

Location

Xiyuan Hospital

Beijing, China

Location

The Ninth People's Hospital of Chongqing

Chongqing, China

Location

Huadong Hospital Affiliated to Fudan University

Shanghai, China

Location

The Second Hospital of Tianjin Medical University

Tianjin, China

Location

Related Publications (3)

• 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.

  PMID: 24237004 BACKGROUND

• 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.

  PMID: 23279591 BACKGROUND

• Zhang Q, Wu Y, Hong S, Feng Y. Trajectory of worst pain within the first two weeks following pelvic and sacral tumor surgery and long-term outcome: a pilot observational prospective cohort study. BMC Anesthesiol. 2023 Mar 9;23(1):73. doi: 10.1186/s12871-023-02033-z.

  PMID: 36894887 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Yi Feng, PhD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

• Xiumei Gao, MD

  Xiyuan Hospital

  STUDY DIRECTOR

• Jingzhi Liu

  Tianjin Medical University Second Hospital

  STUDY DIRECTOR

• Guanghe Si, MD

  Songyuan Central Hospital

  STUDY DIRECTOR

• Yaying Xie

  The Affiliated Hospital of Inner Mongolia Medical University

  STUDY DIRECTOR

• Jun Yan

  Huhhot First Hospital

  STUDY DIRECTOR

• Aizhi Li

  Yantai Yuhuangding Hospital

  STUDY DIRECTOR

• Weiwei Zhang, MD

  Shanxi Provincial People's Hospital

  STUDY DIRECTOR

• Zhenhua Qu, MD

  Xingtai People's Hospital

  STUDY DIRECTOR

• Ying Wang, MD

  The First Affiliated Hospital of Zhengzhou University

  STUDY DIRECTOR

• Hongguang Bao

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

• Weidong Gu

  Huadong Hospital

  STUDY DIRECTOR

• Fan Tao

  Red Cross Hospital, Hangzhou, China

  STUDY DIRECTOR

• Hongwei Wang

  Zhejiang Provincial Tongde Hospital

  STUDY DIRECTOR

• Xianwei Zhang

  Tongji Hospital

  STUDY DIRECTOR

• Qingpeng Dong

  The Third People's Hospital of Hubei Province

  STUDY DIRECTOR

• Qin Liao

  The Third Xiangya Hospital of Central South University

  STUDY DIRECTOR

• Caiping Liao

  The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

  STUDY DIRECTOR

• Haihua Shu

  Guangdong Second Provincial Central Hospital

  STUDY DIRECTOR

• Zhijun Chen

  Guilin Medical University, China

  STUDY DIRECTOR

• Yubo Xie

  First Affiliated Hospital of Guangxi Medical University

  STUDY DIRECTOR

• Bangxiang Yang

  West China Hospital

  STUDY DIRECTOR

• Hui Huang

  The Ninth People's Hospital of Chongqing

  STUDY DIRECTOR

• Xiang Shen

  The First People's Hospital of Liangshan Yi Autonomous Prefecture

  STUDY DIRECTOR

• Shaoxing Dong

  People's Hospital of Yuxi

  STUDY DIRECTOR

• Yimei Li

  First Affiliated Hospital of Xinjiang Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• 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: April 17, 2019
• First Posted: April 25, 2019
• Study Start: June 12, 2019
• Primary Completion: May 8, 2023
• Study Completion: May 8, 2023
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (23)