Inflammation and Postoperative Tramadol Analgesia

Completed

• Conditions: General Surgery

• Registration Number: NCT04330157
• Lead Sponsor: Osijek University Hospital

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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-02-01
• Study First Submitted: 2020-03-30
• Study First Submitted QC: 2020-03-30
• Study First Posted: 2020-04-01
• Results First Submitted: 2021-04-19
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-10
• Last Update Submitted: 2021-07-10
• Results First Posted: 2021-07-30
• Last Update Posted: 2021-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analgesic Affect of Tramadol After Major Abdominal Surgery	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	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.

Trial Locations

Locations (1)

University hospital centre Osijek; 🇭🇷 Osijek, Croatia