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

Systemic Inflammatory Response Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02563652
• Other study ID #: 2015/641
• Status: Completed
• Start date: September 2015
• Est. completion date: September 2018

Study information

• Verified date: November 2018
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Systemic Inflammatory Response Syndrome

Locations

Country	Name	City	State
Italy	University of Parma	Parma
Norway	St Olavs Hospital	Trondheim

Sponsors (4)

Lead Sponsor	Collaborator
St. Olavs Hospital	IRCCS Policlinico S. Matteo, Study in Multidisciplinary Pain Research Group, Italy, University of Parma

Countries where clinical trial is conducted

Italy,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to established circulatory stability for > 2 hours [Time to event outcome]	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
Primary	Time to reaching a state of no or mild pain problem for > 2 hours [Time to event outcome]	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