NCT04330157

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2020

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 30, 2021

Completed
Last Updated

July 30, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

March 30, 2020

Results QC Date

April 19, 2021

Last Update Submit

July 10, 2021

Conditions

General Surgery

Keywords

Postoperative analgesiatramadolintensive care unit

Outcome Measures

Primary Outcomes (2)

  • Analgesic Affect of Tramadol After Major Abdominal Surgery

    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.

    NRS was assessed before and 30 minutes after each tramadol dose during first 24 postoperative hours

  • Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation

    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.

    NRS was assessed before and 30 minutes after each dose of tramadol in a first 24 postoperative hour

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study included patients admitted in the intensive care unit after major abdominal surgery performed with open laparotomy.

You may qualify if:

  • elective and emergency open abdominal surgery
  • ICU admission

You may not qualify if:

  • tramadol allergy
  • surgery performed laparoscopically
  • age younger of 18 years and older the 90 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital centre Osijek

Osijek, 31000, Croatia

Location

Related Publications (4)

  • 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.

    PMID: 31004280BACKGROUND

  • 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.

    PMID: 26574146BACKGROUND

  • 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.

    PMID: 21724620BACKGROUND

  • 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.

    PMID: 28537216BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

CRP, PCT. leukocyte count, lactate, arterial blood gas

Results Point of Contact

Title
Nenad Neskovic
Organization
University hospital Osijek
nneskov@gmail.com
+385996787250

Study Officials

  • Nenad Nešković

    Anesthesiologyst

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 1, 2020

Study Start

January 1, 2019

Primary Completion

January 1, 2020

Study Completion

February 1, 2020

Last Updated

July 30, 2021

Results First Posted

July 30, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)