Inflammation and Postoperative Tramadol Analgesia

Overview

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.

Full Title of Study: “The Influence of Systemic Inflammation on the Analgesic Effect of Tramadol After Major Abdominal Surgery”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 1, 2020

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.

Clinical Trial Outcome Measures

Primary Measures

  • Analgesic Affect of Tramadol After Major Abdominal Surgery
    • Time Frame: NRS was assessed before and 30 minutes after each tramadol dose during first 24 postoperative hours
    • Pain will be assessed before and half an hour after tramadol administration in awake patients by verbal Numeric Rating Scale. This scale has values from 0 to 10, where 0 means no pain and 10 means maximum pain.
  • Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation
    • Time Frame: NRS was assessed before and 30 minutes after each dose of tramadol in a first 24 postoperative hour
    • Differences in Numeric Rating Scale (NRS) in Patients with and without Systemic Inflammation. This scale has values from 0 to 10, where 0 means no pain and 10 means maximum pain.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Osijek University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Nenad Nešković, Principal Investigator, Anesthesiologyst

References

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.

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.

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.

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.

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