Can Biomarkers Aid in the Prediction of Postoperative Pain and Circulatory Instability After Major Abdominal Surgery?

November 12, 2018 updated by: St. Olavs Hospital

Can Biomarkers Aid in the Prediction of Postoperative Pain and Circulatory Instability After Major Abdominal Surgery? A Prospective Observational Study

Patients undergoing major surgery are exposed to extensive damage of tissues, which induces widespread activation of the inflammatory system, called 'systemic inflammatory response syndrome' (SIRS).This activation of the inflammatory system may induce instability of the heart and respiration in the postoperative period. The degree of physiologic response to postoperative SIRS as well as the degree of postoperative pain differ between patients. Therefore, patients undergoing anesthesia and major surgery are treated in a 'post anesthesia care unit' (PACU) after end of surgery.Admittance to a PACU is expensive. The time patients need to stay in a PACU after major surgery has not been extensively studied, and more appropriate tools for prediction of length of stay are needed.

The main aim of this study is to assess whether clinical observations, inflammatory biomarkers or genetic markers may aid in the prediction of physiological instability and/or pain after major surgery. Such predictors would help clinicians planning the length of PACU-stays.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Parma, Italy
        • University of Parma
      • Trondheim, Norway
        • St Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients eligible for major abdominal surgery in St Olavs Hospital, Trondheim, Norway

Description

Inclusion Criteria:

  • Patients undergoing major abdominal surgery (e.g. Whipple's operation, liver resection, abdominoperineal resection, vascular abdominal surgery etc.)
  • Scheduled for PACU stay first 24 hours

Exclusion Criteria:

  • Pregnancy
  • Jehovah's witness
  • Dementia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Major abdominal surgery
Patients undergoing major abdominal surgery (laparotomy). Surgical procedures considered for inclusion include, but are not restricted to, procedures such as gastrectomy, pancreatic surgery, liver resection, open prostatectomy, colonic surgery, radical cystectomy with ileal conduit, open nephrectomy and vascular abdominal aortic surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to established circulatory stability for > 2 hours [Time to event outcome]
Time Frame: 48 hours
Circulatory stability will be assessed by applying a multi-state statistical model, where any state changes are measured at an hourly basis. The model will include variables reflecting the circulatory state of the patient, including heart rate, systolic blood pressure (or MAP) and lactate, which will be assessed together with the measures needed to maintain them, such as the amount of fluid given (ml per hour) and the extent of vasopressor (i.e. norepinephrine). The main outcome variable will be the time needed to reach the state of 'stable without intervention for more than two hours. To be classified in this state, the systolic blood pressure must be > 100 mmHg, the heart rate between 40 and 110, the patient must be off vasopressor and has a fluid requirement of less than 250 ml/hour.
48 hours
Time to reaching a state of no or mild pain problem for > 2 hours [Time to event outcome]
Time Frame: 48 hours
This outcome will be reached when the patient has a numeric rating score (NRS) with respect to pain of < 4 and the opioid consumption is less than 5 mg morphine equivalents per hour.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Erik Solligård, phd md, St. Olavs Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

September 8, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (Estimate)

September 30, 2015

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 12, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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