Postoperative PainNCT04318860
Postoperative Pain After Colorectal Surgery
An observational study of Postoperative Pain, run by Umeå University at 1 site in Sweden.
Trial summary
This study aimed to evaluate pain after elective colorectal surgery and to identify risk factors for postoperative pain. Patients:All elective colorectal surgeries at the department of surgery, Umeå university Hospital, Umeå, Sweden from March 2013 to April 2017 Primary outcome:The primary outcome measurement is the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- How many people
- 459 participants
- Where
- 1 siteSweden
- Study dates
- 15 Mar 2013to 1 Oct 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adults undergoing elective colorectal surgery
Inclusion Criteria: Consecutive adults undergoing elective open and minimally invasive colorectal surgery at the Department of Surgery, Umeå University Hospital, from March 2013 to April 2017
Exclusion Criteria: Patients not scoring pain at any of 4 postoperative days.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept of Surgery, Inst of Surgical and Perioperative sciences
Umeå, Umea, 901 85
About this study
This study aimed to evaluate pain after elective colorectal surgery and to identify risk factors for postoperative pain.
Patients:All elective colorectal surgeries at the department of surgery, Umeå university Hospital, Umeå, Sweden from March 2013 to April 2017
Primary outcome:The primary outcome measurement is the numeric rating scale (NRS), graded from 0-10, on day of surgery, postoperative (POD) 1, 2, 3. The patients are questioned by nurses each morning on four postoperative days to score the maximum pain during the previous 24 hours using the NRS.
Read the detailed description
This study aimed to quantify pain after elective colorectal surgery and to identify risk factors for postoperative pain.
Patients: This prospective cohort study includes all consecutive patients undergoing elective colorectal surgery at Umeå University Hospital in Sweden between March 2013 and April 2017.
Exclusion criteria: Patients who do not score pain at any of 4 postoperative days.
Primary outcome:The primary outcome measurement is the Numeric rating scale (NRS), graded from 0-10, where 0 = no pain and 10 = the worst imaginable pain [18]. Moderate pain is defined as NRS 4-6 and severe pain as NRS 7-10. The patients are questioned by nurses each morning after day of surgery, postoperative day. 1, postoperative day 2 and postoperative day 3 to score the maximum pain during the previous 24 hours using the NRS.
All data are registered in Enhanced recovery after surgery database (EISA)
Clinical variables: Baseline clinical variables are assessed preoperatively. They included age, gender, body mass index (BMI), smoking, a diabetes mellitus diagnosis and American Society of Anesthesia (ASA) class. The postoperative course is registered prospectively in Enhanced recovery after surgery register (EIAS) and include preoperative oncological treatment, a histopathologically verified cancer diagnosis, the length of hospital stay and complications, including any complication, Clavien-Dindo 3b or more and anastomotic leakage within 30 days after surgery High-sensitivity C-reactive protein (CRP) is measured every postoperative morning.
- Conditions
- Postoperative Pain
- Keywords
- Postoperative pain, Colorectal surgery, Numeric rating scale, Minimally invasive surgery, Risk factors
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum pain on day of surgery
Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)
Measured: Day of surgery
Maximum pain on postoperative day 1
Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)
Measured: Postoperative day 1
Maximum pain on postoperative day 2
Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)
Measured: Postoperative day 2
Maximum pain on postoperative day 3
Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)
Measured: Postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start15 Mar 2013
- Primary completion1 Apr 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karl A Franklin, prof, Principal investigator, Dept Surgical and periopertive sciences, Umeå university, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318860
- Sponsor's protocol ID
- 2016/507-31
- Status last verified
- Aug 2019
- First submitted
- 17 Mar 2020
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain After Colorectal Surgery
- ClinicalTrials.gov ID
- NCT04318860
- Acronym / sponsor ID
- 2016/507-31
- Conditions
- Postoperative Pain
- Keywords
- Postoperative pain, Colorectal surgery, Numeric rating scale, Minimally invasive surgery, Risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 15 Mar 2013 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 24 Mar 2020 (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.
This study aimed to evaluate pain after elective colorectal surgery and to identify risk factors for postoperative pain.
Patients:All elective colorectal surgeries at the department of surgery, Umeå university Hospital, Umeå, Sweden from March 2013 to April 2017
Primary outcome:The primary outcome measurement is the numeric rating scale (NRS), graded from 0-10, on day of surgery, postoperative (POD) 1, 2, 3. The patients are questioned by nurses each morning on four postoperative days to score the maximum pain during the previous 24 hours using the NRS.
Detailed description
This study aimed to quantify pain after elective colorectal surgery and to identify risk factors for postoperative pain.
Patients: This prospective cohort study includes all consecutive patients undergoing elective colorectal surgery at Umeå University Hospital in Sweden between March 2013 and April 2017.
Exclusion criteria: Patients who do not score pain at any of 4 postoperative days.
Primary outcome:The primary outcome measurement is the Numeric rating scale (NRS), graded from 0-10, where 0 = no pain and 10 = the worst imaginable pain [18]. Moderate pain is defined as NRS 4-6 and severe pain as NRS 7-10. The patients are questioned by nurses each morning after day of surgery, postoperative day. 1, postoperative day 2 and postoperative day 3 to score the maximum pain during the previous 24 hours using the NRS.
All data are registered in Enhanced recovery after surgery database (EISA)
Clinical variables: Baseline clinical variables are assessed preoperatively. They included age, gender, body mass index (BMI), smoking, a diabetes mellitus diagnosis and American Society of Anesthesia (ASA) class. The postoperative course is registered prospectively in Enhanced recovery after surgery register (EIAS) and include preoperative oncological treatment, a histopathologically verified cancer diagnosis, the length of hospital stay and complications, including any complication, Clavien-Dindo 3b or more and anastomotic leakage within 30 days after surgery High-sensitivity C-reactive protein (CRP) is measured every postoperative morning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults undergoing elective colorectal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maximum pain on day of surgery
Time frame: Day of surgery
Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)
Maximum pain on postoperative day 1
Time frame: Postoperative day 1
Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)
Maximum pain on postoperative day 2
Time frame: Postoperative day 2
Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)
Maximum pain on postoperative day 3
Time frame: Postoperative day 3
Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)
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 24 Mar 2020.
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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.
Karl A Franklin, prof principal investigator
Dept Surgical and periopertive sciences, Umeå university, Sweden
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 Postoperative Pain, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 24 Mar 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 Sweden. 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?
Maximum pain on day of surgery (time frame: Day of surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2020.