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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03926858

Recruitment Status Not yet recruiting

First Posted April 25, 2019

Last update posted April 25, 2019

Study Description

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.

  • Condition or Disease:Post Surgical Pain
  • Intervention/Treatment:
  • Phase: N/A
Detailed 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. The investigator will approach to the screened patients one day before surgery (Day-1), using a letter of invitation to explain the survey, and obtain an informed consent. Questionnaires for pre-surgical assessment will be administrated by a face-to-face interview. Follow-ups will be performed at several time-points within six month after surgery to evaluate pain and recovery by face-to-face interview or by telephone interview if the patient is discharged. Patients' medical charts will be reviewed by investigators to record sociodemographic and clinical data.

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 2000 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Patient-reported Outcomes of Postsurgical Pain and Health Related Quality of Life, a Multi-centered, Prospective, Observational, Cohort Study
  • Estimated Study Start Date: April 2019
  • Estimated Primary Completion Date: November 2020
  • Estimated Study Completion Date: December 2020
Outcome Measures
  • Primary Outcome Measures: 1. The trajectories of health related quality of life(HRQoL) [ Time Frame: up to 6 months after surgery ]
    The trajectory of HRQoL is the vector of Utility values measured with EuroQol five-dimensional questionnaire(EQ-5D)taken over 6 months(days 1, 3, 7,14, 21, 30, 60, 90, 120, 150,180; Day 0 is the day of surgery). The EQ-5D measures health on five domains (mobility, self-care, usual activities, pain discomfort, and anxiety-depression), and the scores will be combined using Chinese general population weights to generate a single utility or index score. Utility values for the EQ-5D range from 1.00 to -0.391, where a score of 0 and 1 are regarded as equivalent to death and 'perfect health', respectively, and a score < 0 is considered as health state that is 'worse than death'.
  • 2. pain trajectories after surgery [ Time Frame: up to 6 months after surgery ]
    The pain trajectory is the vector of mean pain severity domain scores (from 0 to 10)measured with pain severity domain of the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) and Brief Pain Inventory -Short Form (BPI-SF) within 6 months after surgery(days 1, 3, 7,14, 21, 30, 60, 90, 120, 150,180; Day 0 is the day of surgery).
  • Secondary Outcome Measures: 1. ambulation time [ Time Frame: up to 30 days after surgery ]
    the first time when patients can get off of bed and walk after surgery
  • 2. oral feeding time [ Time Frame: up to 30 days after surgery ]
    the first time when patients begin oral feeding after surgery
  • 3. Complications within 30 days after surgery [ Time Frame: up to 30 days after surgery ]
    Complications within 30 days after surgery will be classified using Clavien-Dindo Classification of Surgical Complications, ranging from Grade I(Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions) to Grade V(death of a patient).
  • 4. Number of readmission within 30 days after surgery [ Time Frame: up to 30 days after surgery ]
    Readmission indicates unplanned readmission after hospital discharge.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Probability Sample
  • Study Population: patients undergoing the following procedures: breast surgery, thoracic surgery, abdominal surgery, total knee or hip replacement surgery and spine surgery.
Criteria

Inclusion Criteria:

- 18 years or older

- Undergoing general or regional anesthesia

- Hospitalized for at least 24 hours after surgery

- Able to give informed consent

- Able to read and write

Exclusion Criteria:

- Existing diagnoses of psychiatric or neurologic pathology

- A history of substance abuse

- Admitted to ICU after surgery

Contacts and Locations
Contacts

Contact: Yi Feng, MD, PhD 86-010-88325581 littlevon@163.com

Locations
Sponsors and Collaborators

Peking University People's Hospital

Investigators

Principal Investigator: Yi Feng, PhD Peking University People's Hospital

Study Director: 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 Shaanxi 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 Hangzhou Red Cross Hospital

Study Director: Hongwei Wang Zhejiang Provincial Tongde Hospital

Study Director: Xianwei Zhang Tongji Hospital

Study Director: Qingpeng Dong The Third People's Hospital of Zhejiang 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

More Information