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Completed

NCT Number: NCT04318860

Postoperative Pain After Colorectal Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept of Surgery, Inst of Surgical and Perioperative sciences

Umeå, Umea, 901 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Maximum pain on day of surgery

    Time frame: Day of surgery

    Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)

  2. Maximum pain on postoperative day 1

    Time frame: Postoperative day 1

    Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)

  3. Maximum pain on postoperative day 2

    Time frame: Postoperative day 2

    Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)

  4. Maximum pain on postoperative day 3

    Time frame: Postoperative day 3

    Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Mar 24, 2020
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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