Pain, PostoperativeNCT03731039
Postoperative Pain in Adult Patients.
An observational study of Pain, Postoperative and Surgical Procedures, Operative, run by Andrzej Frycz Modrzewski Krakow University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pain, Postoperative, Surgical Procedures, Operative
- What is being tested?
- Observational study
- How many people
- 620 participants
- Where
- 1 sitePoland
- Study dates
- 21 Sep 2017to 31 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients underoing surgical procedures performed on general or regional anesthesia.
Who may be able to join
- adult
- elective surgery
- the American Society of Anesthesiologists score 1-3
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Andrzej Frycz-Modrzewski Krakow University
Krakow, Lesser Poland Voivodeship, 30-705
About this study
Official title: 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.
- Being tested
- Observational study
- Keywords
- Postoperative pain, Anxiety, Depression, Adult
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Pain assessment, Anxiety assessment, Depression assessment
| Study group | Role | What they receive |
|---|---|---|
| SURGICAL PROCEDURES ASSOCIATED WITH SLIGHT TISSUE DAMAGE | Not described Receives: Other: Observational study | |
| SURGICAL PROCEDURES ASSOCIATED WITH MODERATE TISSUE DAMAGE | Not described Receives: Other: Observational study | |
| SURGICAL PROCEDURES ASSOCIATED WITH SUBSTANTIAL TISSUE DAMAGE | Not described Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: first 24 hours after surgery
Secondary outcomes (2)
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).
Measured: 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).
Measured: day prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start21 Sep 2017
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 620 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrzej Frycz Modrzewski Krakow University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucyna Tomaszek, Andrzej Frycz Modrzewski Krakow University
- Investigators
- Lucyna Tomaszek, Study director, Andrzej Frycz Modrzewski Krakow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731039
- Sponsor's protocol ID
- WLNZ/DS/3/2018
- Status last verified
- Jul 2020
- First submitted
- 2 Nov 2018
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30021520Misiolek 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.
PubMed 25293474Tomaszek 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.
PubMed 29218814
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of Postoperative Pain Control in Adults After Different Types of Surgeries.
- ClinicalTrials.gov ID
- NCT03731039
- Acronym / sponsor ID
- WLNZ/DS/3/2018
- Keywords
- Postoperative pain, Anxiety, Depression, Adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 620 participants (actual)
- Lead sponsor
- Andrzej Frycz Modrzewski Krakow UniversityUniversity, hospital or other
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients underoing surgical procedures performed on general or regional anesthesia.
Key inclusion criteria (3 listed)
- adult
- elective surgery
- the American Society of Anesthesiologists score 1-3
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyPain assessment, Anxiety assessment, Depression assessment | Other | SURGICAL PROCEDURES ASSOCIATED WITH MODERATE TISSUE DAMAGE, SURGICAL PROCEDURES ASSOCIATED WITH SLIGHT TISSUE DAMAGE, SURGICAL PROCEDURES ASSOCIATED WITH SUBSTANTIAL TISSUE DAMAGE |
Primary outcome
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.
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.
2 secondary outcomes
Anxiety scores
Time frame: day prior to surgery
Depression scores
Time frame: day prior to surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Background: PubMed 30021520Borys 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.
- Background: PubMed 25293474Misiolek 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.
- Results publication: PubMed 29218814Tomaszek 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucyna Tomaszek study director
Andrzej Frycz Modrzewski Krakow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative and Surgical Procedures, Operative, run by Andrzej Frycz Modrzewski Krakow University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity scores at rest (time frame: first 24 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03731039, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.