Inflammation and Postoperative Tramadol Analgesia

O

Osijek University Hospital

Status

Completed

Conditions

General Surgery

Study type

Observational

Funder types

Other

Identifiers

NCT04330157
OsijekUH-6

Details and patient eligibility

About

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 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.

Enrollment

50 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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