General SurgeryNCT04330157

Inflammation and Postoperative Tramadol Analgesia

An observational study of General Surgery, run by Osijek University Hospital at 1 site in Croatia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: General Surgery
How many people: 50 participants
Where: 1 siteCroatia
Study dates: 1 Jan 2019to 1 Feb 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

elective and emergency open abdominal surgery
ICU admission

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Croatia1 site

University hospital centre Osijek
Osijek, 31000

Other trials in Croatia

About this study

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

Read the 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
Keywords: Postoperative analgesia, tramadol, intensive care unit

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20191 Feb 2020

First posted1 Apr 2020
Study start1 Jan 2019
Primary completion1 Jan 2020
Study completion1 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for General SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04330157
Sponsor's protocol ID: OsijekUH-6
Status last verified: Jul 2021
First submitted: 30 Mar 2020
Last updated: 30 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 31004280
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.
PubMed 26574146
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.
PubMed 21724620
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.
PubMed 28537216

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
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Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
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WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC
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Active, not recruiting
Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
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Recruiting
NOL Guided Analgesia During Elective Laparoscopic Surgery Under General Anesthesia
Intraoperative Analgesia

All General Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Influence of Systemic Inflammation on the Analgesic Effect of Tramadol After Major Abdominal Surgery
ClinicalTrials.gov ID: NCT04330157
Acronym / sponsor ID: OsijekUH-6
Conditions: General Surgery
Keywords: Postoperative analgesia, tramadol, intensive care unit
Study type: Observational
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Osijek University HospitalUniversity, hospital or other
Study start: 1 Jan 2019 (actual)
Primary completion: 1 Jan 2020 (actual)
Study completion: 1 Feb 2020 (actual)
First posted: 1 Apr 2020 (actual)
Results: Posted 30 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study included patients admitted in the intensive care unit after major abdominal surgery performed with open laparotomy.

Key inclusion criteria (2 listed)

elective and emergency open abdominal surgery
ICU admission

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.
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.

Results and safety

Results posted to the registry on 30 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Included in the Study	50	43

Primary outcome: 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. Median (Inter-Quartile Range). Unit: Score on a scale

Measure	NRS Score Before Tramadol Application n = 43	NRS Score After Tramadol Application n = 43
1st assessment	7 (3.5 to 9.5)	5 (4.25 to 6)
2nd assessment	5 (3 to 6.5)	3 (1 to 5)
3rd assessment	4 (2.5 to 5)	2 (1 to 3)
4th assessment	4 (2 to 5)	2 (1 to 4)
5th assessment	3 (2 to 5)	2 (0 to 3)

Population analysed: NRS score was determinated only in awake patients

Primary outcome: 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. Median (Inter-Quartile Range). Unit: score on a scale

Measure	NRS Before Tramadol - no Systemic Inflammation n = 28	NRS After Tramadol - no Systemic Inflammation n = 28	NRS Before Tramadol - With Systemic Inflammation n = 15	NRS After Tramadol - With Systemic Inflammation n = 15
1st assessment	7 (3 to 10)	5 (3.5 to 5)	7 (7 to 7)	7 (6 to 7)
2nd assessment	5.5 (3.57 to 7.25)	3 (1 to 4.25)	4 (3 to 5)	2 (1 to 5)
3rd assessment	4 (3 to 5)	2 (1.25 to 3)	3 (2 to 5)	2 (0.5 to 4)
4th assessment	4 (2 to 5)	2.5 (1 to 4)	3 (2 to 7.25)	2 (1 to 3.5)
5th assessment	3 (2 to 5.75)	2 (0.25 to 3.57)	3 (2 to 5)	2 (0 to 3)

Population analysed: NRS was assessed only in awake patients

Adverse events

Time frame: 24 hours. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adverse Effect	0 of 43 (0%)	16 of 43 (37.2%)	0 of 43

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31004280Barakat 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.
Background: PubMed 26574146He 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.
Background: PubMed 21724620Gerbershagen 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.
Background: PubMed 28537216Mallick 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.
Individual participant dataSharing planned: No

Related trials for General Surgery

RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
RecruitingPhase 2
WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC
Epithelial Ovarian Cancer
Active, not recruiting
Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
Nasal Polyps
Recruiting
NOL Guided Analgesia During Elective Laparoscopic Surgery Under General Anesthesia
Intraoperative Analgesia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nenad Nešković principal investigator

Anesthesiologyst

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of General Surgery, run by Osijek University Hospital at 1 site in Croatia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04330157, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.