Clinical trial NCT04318860: Postoperative Pain After Colorectal Surgery
Official title: Postoperative Pain After Colorectal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Keywords: Postoperative pain
Colorectal surgery
Numeric rating scale
Minimally invasive surgery
Risk factors
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 459
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adults undergoing elective colorectal surgery

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum pain on day of surgery
timeFrame: Day of surgery
measure: Maximum pain on postoperative day 1
timeFrame: Postoperative day 1
measure: Maximum pain on postoperative day 2
timeFrame: Postoperative day 2
measure: Maximum pain on postoperative day 3
timeFrame: Postoperative day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Dept of Surgery, Inst of Surgical and Perioperative sciences
state: Umea
Study officials:
affiliation: Dept Surgical and periopertive sciences, Umeå university, Sweden
name: Karl A Franklin, prof
role: PRINCIPAL_INVESTIGATOR
References: