Postoperative Pain in Adult Patients.
July 7, 2020 updated by: Lucyna Tomaszek, Andrzej Frycz Modrzewski Krakow University
Survey of Postoperative Pain Control in Adults After Different Types of Surgeries.
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
620
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Lesser Poland
-
Krakow, Lesser Poland, Poland, 30-705
- Andrzej Frycz-Modrzewski Krakow University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult patients underoing surgical procedures performed on general or regional anesthesia.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
SURGICAL PROCEDURES ASSOCIATED WITH SLIGHT TISSUE DAMAGE
|
Pain assessment, Anxiety assessment, Depression assessment
|
|
SURGICAL PROCEDURES ASSOCIATED WITH MODERATE TISSUE DAMAGE
|
Pain assessment, Anxiety assessment, Depression assessment
|
|
SURGICAL PROCEDURES ASSOCIATED WITH SUBSTANTIAL TISSUE DAMAGE
|
Pain assessment, Anxiety assessment, Depression assessment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
first 24 hours after surgery
|
|
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.
|
first 24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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). |
day prior to surgery
|
|
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). |
day prior to surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Lucyna Tomaszek, Andrzej Frycz Modrzewski Krakow University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Borys M, Zyzak K, Hanych A, Domagala M, Galkin P, Galaszkiewicz K, Klaput A, Wroblewski K, Miekina J, Onichimowski D, Czuczwar M. Survey of postoperative pain control in different types of hospitals: a multicenter observational study. BMC Anesthesiol. 2018 Jul 18;18(1):83. doi: 10.1186/s12871-018-0551-3.
- Misiolek H, Cettler M, Woron J, Wordliczek J, Dobrogowski J, Mayzner-Zawadzka E. The 2014 guidelines for post-operative pain management. Anaesthesiol Intensive Ther. 2014 Sep-Oct;46(4):221-44. doi: 10.5603/AIT.2014.0041. No abstract available.
- Tomaszek L, Debska G. Knowledge, compliance with good clinical practices and barriers to effective control of postoperative pain among nurses from hospitals with and without a "Hospital without Pain" certificate. J Clin Nurs. 2018 Apr;27(7-8):1641-1652. doi: 10.1111/jocn.14215. Epub 2018 Mar 2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 21, 2017
Primary Completion (Actual)
October 31, 2019
Study Completion (Actual)
October 31, 2019
Study Registration Dates
First Submitted
November 2, 2018
First Submitted That Met QC Criteria
November 5, 2018
First Posted (Actual)
November 6, 2018
Study Record Updates
Last Update Posted (Actual)
July 8, 2020
Last Update Submitted That Met QC Criteria
July 7, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WLNZ/DS/3/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.