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NCT Number: NCT03926858

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University People's Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Health related quality of life(HRQoL)

    Time frame: up to 6 months after surgery

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

  2. Pain after surgery

    Time frame: up to 6 months after surgery

    Postsurgical pain is measured with the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) .

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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

Acronym: HRQoL

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 25, 2019
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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