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Completed

NCT Number: NCT04330157

Inflammation and Postoperative Tramadol Analgesia

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.

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Key information

Conditions

General Surgery

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital centre Osijek

Osijek, 31000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Osijek University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 1, 2020
Registry last updated
Jul 30, 2021

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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