NCT04330157

Inflammation and Postoperative Tramadol Analgesia

The Influence of Systemic Inflammation on the Analgesic Effect of Tramadol After Major Abdominal Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Osijek University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• General Surgery

Timeline

• Start date: 2019-01-01
• Primary completion: 2020-01-01
• Completion: 2020-02-01
• First posted: 2020-04-01
• Last updated: 2021-07-30
• Results posted: 2021-07-30

Locations

1 site across 1 country: Croatia