Postoperative Pain in Adult Patients.

Completed

• Conditions: Pain, Postoperative; Surgical Procedures, Operative
• Interventions: Other: Observational study

• Registration Number: NCT03731039
• Lead Sponsor: Andrzej Frycz Modrzewski Krakow University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-21
• Study First Submitted: 2018-11-02
• Study First Submitted QC: 2018-11-05
• Study First Posted: 2018-11-06
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 620

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SURGICAL PROCEDURES ASSOCIATED WITH SLIGHT TISSUE DAMAGE	Observational study	-
SURGICAL PROCEDURES ASSOCIATED WITH MODERATE TISSUE DAMAGE	Observational study	-
SURGICAL PROCEDURES ASSOCIATED WITH SUBSTANTIAL TISSUE DAMAGE	Observational study	-

Primary Outcome Measures

Name	Time	Method
Pain intensity scores at rest	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.
Pain intensity scores on movement	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 Outcome Measures

Name	Time	Method
Anxiety scores	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).
Depression scores	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).

Trial Locations

Locations (1)

Andrzej Frycz-Modrzewski Krakow University; 🇵🇱 Krakow, Lesser Poland, Poland