Postoperative Pain in Adult Patients.

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
• Conditions: Pain, Postoperative; Surgical Procedures, Operative
• Intervention / Treatment: Other: Observational study

• Study Type: Observational
• Enrollment (Actual): 620

Contacts and Locations

Study Locations

• Poland
  • Lesser Poland
    • Krakow, Lesser Poland, Poland, 30-705
      • Andrzej Frycz-Modrzewski Krakow University

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SURGICAL PROCEDURES ASSOCIATED WITH SLIGHT TISSUE DAMAGE	Other: Observational study; Pain assessment, Anxiety assessment, Depression assessment
SURGICAL PROCEDURES ASSOCIATED WITH MODERATE TISSUE DAMAGE	Other: Observational study; Pain assessment, Anxiety assessment, Depression assessment
SURGICAL PROCEDURES ASSOCIATED WITH SUBSTANTIAL TISSUE DAMAGE	Other: Observational study; 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	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	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	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	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

• Sponsor: Andrzej Frycz Modrzewski Krakow University
• Investigators: Study Director: Lucyna Tomaszek, Andrzej Frycz Modrzewski Krakow University

Publications and helpful links

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

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: Depression; Anxiety; Adult; Postoperative pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• 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