NCT03731039

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
620

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

2.1 years

First QC Date

November 2, 2018

Last Update Submit

July 7, 2020

Conditions

Pain, PostoperativeSurgical Procedures, Operative

Keywords

Postoperative painAnxietyDepressionAdult

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Anxiety scores

    day prior to surgery

  • Depression scores

    day prior to surgery

Study Arms (3)

SURGICAL PROCEDURES ASSOCIATED WITH SLIGHT TISSUE DAMAGE

Other: Observational study

SURGICAL PROCEDURES ASSOCIATED WITH MODERATE TISSUE DAMAGE

Other: Observational study

SURGICAL PROCEDURES ASSOCIATED WITH SUBSTANTIAL TISSUE DAMAGE

Other: Observational study

Interventions

Observational studyOTHER

Pain assessment, Anxiety assessment, Depression assessment

SURGICAL PROCEDURES ASSOCIATED WITH MODERATE TISSUE DAMAGESURGICAL PROCEDURES ASSOCIATED WITH SLIGHT TISSUE DAMAGESURGICAL PROCEDURES ASSOCIATED WITH SUBSTANTIAL TISSUE DAMAGE

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients underoing surgical procedures performed on general or regional anesthesia.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andrzej Frycz-Modrzewski Krakow University

Krakow, Lesser Poland Voivodeship, 30-705, Poland

Location

Related Publications (3)

  • 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.

    PMID: 30021520BACKGROUND

  • 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.

    PMID: 25293474BACKGROUND

  • 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.

    PMID: 29218814RESULT

MeSH Terms

Conditions

Pain, PostoperativeAnxiety DisordersDepression

Interventions

Observation

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Lucyna Tomaszek

    Andrzej Frycz Modrzewski Krakow University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Specialist Nurse in Anesthesia and Intensive Care

Study Record Dates

First Submitted

November 2, 2018

First Posted

November 6, 2018

Study Start

September 21, 2017

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

July 8, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)