Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
Study NCT ID:
NCT04318860
Status:
COMPLETED
Last Update Posted:
2020-03-24
First Post:
2020-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Pain After Colorectal Surgery
Sponsor:
Umeå University
Organization:
Study Overview
Official Title:
Postoperative Pain After Colorectal Surgery
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: