Clinical trial NCT04330157: Inflammation and Postoperative Tramadol Analgesia
Official title: The Influence of Systemic Inflammation on the Analgesic Effect of Tramadol After Major Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Surgery
Keywords: Postoperative analgesia
tramadol
intensive care unit
Lead sponsor: Osijek University Hospital
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study included patients admitted in the intensive care unit after major abdominal surgery performed with open laparotomy.

Brief summary: Patients will be admitted in the intensive care unit after major abdominal surgery. All patients will receive 100 mg of tramadol intravenously every 6 hours. Pain will be assessed before and half an hour after tramadol administration by verbal Numeric Rating Scale.

Detailed description: To all patients included in the study from the blood sample taken prior to the operation the leukocytes counts, c-reactive protein (CRP), procalcitonin (PCT) and lactate level will be performed, as well as arterial blood gas analysis.

After admission to the intensive care unit, all patients will receive 100 mg of tramadol intravenously every 6 hours. Pain will be assessed before and half an hour after tramadol administration by verbal Numeric Rating Scale (NRS). Pain score will be compared between patients with and without systemic inflammation. Systemic inflammation is defined as fulfilling at least two of the following major criteria: fever \> 38 oC or hypothermia \< 36 oC, tachycardia \> 90 beats/minute, pCO2 in arterial blood \< 4.3 kPa and leukocytes \> 12.000/mm3 or \< 4.000/mm3. Also, preoperative values of CRP \> 50 mg/L and PCT \> 0.5 ng/ml was also considered systemic inflammation.

Eligibility criteria: Inclusion Criteria:

* elective and emergency open abdominal surgery
* ICU admission

Exclusion Criteria:

* tramadol allergy
* surgery performed laparoscopically
* age younger of 18 years and older the 90 years

Primary outcomes:
measure: Analgesic Affect of Tramadol After Major Abdominal Surgery
timeFrame: NRS was assessed before and 30 minutes after each tramadol dose during first 24 postoperative hours
measure: Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation
timeFrame: NRS was assessed before and 30 minutes after each dose of tramadol in a first 24 postoperative hour
Secondary outcomes:
Other outcomes:
Locations:
city: Osijek
country: Croatia
facility: University hospital centre Osijek
Study officials:
affiliation: Anesthesiologyst
name: Nenad Nešković
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barakat A. Revisiting Tramadol: A Multi-Modal Agent for Pain Management. CNS Drugs. 2019 May;33(5):481-501. doi: 10.1007/s40263-019-00623-5.
citation: He ZX, Chen XW, Zhou ZW, Zhou SF. Impact of physiological, pathological and environmental factors on the expression and activity of human cytochrome P450 2D6 and implications in precision medicine. Drug Metab Rev. 2015;47(4):470-519. doi: 10.3109/03602532.2015.1101131. Epub 2015 Nov 16.
citation: Gerbershagen HJ, Rothaug J, Kalkman CJ, Meissner W. Determination of moderate-to-severe postoperative pain on the numeric rating scale: a cut-off point analysis applying four different methods. Br J Anaesth. 2011 Oct;107(4):619-26. doi: 10.1093/bja/aer195. Epub 2011 Jun 30.
citation: Mallick P, Taneja G, Moorthy B, Ghose R. Regulation of drug-metabolizing enzymes in infectious and inflammatory disease: implications for biologics-small molecule drug interactions. Expert Opin Drug Metab Toxicol. 2017 Jun;13(6):605-616. doi: 10.1080/17425255.2017.1292251. Epub 2017 Feb 22.