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Completed

NCT Number: NCT03731039

Postoperative Pain in Adult Patients.

Each surgical intervention associated with even a minor tissue injury is a source of pain which needs to be effectively controlled. Although the Polish national guidelines for post-operative pain management have been published, many patients experience moderate and severe pain in the postoperative period. The aim of this study is (1) to assess pain severity among adult patients after different types of surgeries; (2) to identify demographic and clinical factors associated with postoperative pain.

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Key information

Conditions

Pain, Postoperative Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgical Procedures, Operative

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Andrzej Frycz-Modrzewski Krakow University

Krakow, Lesser Poland Voivodeship, 30-705, Poland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult
  • elective surgery
  • the American Society of Anesthesiologists score 1-3

Exclusion criteria

  • diagnosed mental illness, alcohol abuse disorders, intellectual disability
  • traumatic events within the last 6 months (e.g. death, breakdown of a relationship, job loss)
  • problems with verbal communication

Treatment and study plan

observational study

Other

Pain assessment, Anxiety assessment, Depression assessment

Primary outcomes

  1. Pain intensity scores at rest

    Time frame: first 24 hours after surgery

    Pain intensity is assessed using the Numeric Rating Scale (NRS), where 0 meant no pain and 10 maximum pain. Numeric scores of 1-3, 4-6, and 7-10 corresponded to mild, moderate and severe pain.

  2. Pain intensity scores on movement

    Time frame: first 24 hours after surgery

    Pain intensity is assessed using the Numeric Rating Scale (NRS), where 0 meant no pain and 10 maximum pain. Numeric scores of 1-3, 4-6, and 7-10 corresponded to mild, moderate and severe pain.

Secondary outcomes

  1. Anxiety scores

    Time frame: day prior to surgery

    Anxiety is evaluated using the Hospital Anxiety and Depression Scale - HADS. It consists of 7 items grouped in sub-scales: anxiety (HADS-A) and depression (HADS-D). The answers describe the patient's well-being over the last week and are coded on a scale of 0-3 points.

    HADS-A: the total score amounts to 0-21 points (0-7 points = norm, 8-10 = borderline, ≥11 points = clinical levels of symptoms).

  2. Depression scores

    Time frame: day prior to surgery

    Depression is evaluated using the Hospital Anxiety and Depression Scale - HADS. It consists of 7 items grouped in sub-scales: anxiety (HADS-A) and depression (HADS-D). The answers describe the patient's well-being over the last week and are coded on a scale of 0-3 points.

    HADS-D: the total score amounts to 0-21 points (0-7 points = norm, 8-10 = borderline, ≥11 points = clinical levels of symptoms).

Sponsors and collaborators

Lead sponsor

Andrzej Frycz Modrzewski Krakow University

Other

Registry information

Official study title

Survey of Postoperative Pain Control in Adults After Different Types of Surgeries.

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 6, 2018
Registry last updated
Jul 8, 2020

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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