Postoperative Pain After Colorectal Surgery

NCT ID: NCT04318860

Last Updated: 2020-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

459 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-15

Study Completion Date

2017-10-01

Brief Summary

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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

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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.

Conditions

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Postoperative Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karl A Franklin, prof

Role: PRINCIPAL_INVESTIGATOR

Dept Surgical and periopertive sciences, Umeå university, Sweden

Locations

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Dept of Surgery, Inst of Surgical and Perioperative sciences

Umeå, Umea, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2016/507-31

Identifier Type: -

Identifier Source: org_study_id

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