Postoperative Pain After Colorectal Surgery

Completed

• Conditions: Postoperative Pain

• Registration Number: NCT04318860
• Lead Sponsor: Umeå University

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.

Study Timeline

• Study Start: 2013-03-15
• Primary Completion: 2017-04-01
• Study Completion: 2017-10-01
• Status Verified: 2019-08
• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-03-23
• Last Update Submitted: 2020-03-23
• Study First Posted: 2020-03-24
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 459

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum pain on postoperative day 1	Postoperative day 1	Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)
Maximum pain on postoperative day 2	Postoperative day 2	Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)
Maximum pain on postoperative day 3	Postoperative day 3	Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)
Maximum pain on day of surgery	Day of surgery	Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)

Trial Locations

Locations (1)

Dept of Surgery, Inst of Surgical and Perioperative sciences; 🇸🇪 Umeå, Umea, Sweden