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NCT Number: NCT02563652

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

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.

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Key information

Conditions

Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Parma, Parma, Italy

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Fondazione IRCCS Policlinico San Matteo di Pavia
  • Study in Multidisciplinary Pain Research Group, Italy
  • University of Parma

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 30, 2015
Registry last updated
Nov 14, 2018

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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