Postoperative Pain After Colorectal Surgery

Postoperative Pain Clinical Trial

Official title:

Postoperative Pain After Colorectal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04318860
• Other study ID #: 2016/507-31
• Status: Completed
• Start date: March 15, 2013
• Est. completion date: October 1, 2017

Study information

• Verified date: August 2019
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 459
• Est. completion date: October 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Locations

Country	Name	City	State
Sweden	Dept of Surgery, Inst of Surgical and Perioperative sciences	Umeå	Umea

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum pain on day of surgery	Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)	Day of surgery
Primary	Maximum pain on postoperative day 1	Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)	Postoperative day 1
Primary	Maximum pain on postoperative day 2	Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)	Postoperative day 2
Primary	Maximum pain on postoperative day 3	Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)	Postoperative day 3