Trial Outcomes & Findings for Inflammation and Postoperative Tramadol Analgesia (NCT NCT04330157)
NCT ID: NCT04330157
Last Updated: 2021-07-30
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
50 participants
Primary outcome timeframe
NRS was assessed before and 30 minutes after each tramadol dose during first 24 postoperative hours
Results posted on
2021-07-30
Participant Flow
Participant milestones
| Measure |
Patients Included in the Study
The study included patients admitted to the ICU after major abdominal surgeries.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Patients Included in the Study
The study included patients admitted to the ICU after major abdominal surgeries.
|
|---|---|
|
Overall Study
Protocol Violation
|
4
|
|
Overall Study
Not extubated within 24 h postoperatively
|
3
|
Baseline Characteristics
Inflammation and Postoperative Tramadol Analgesia
Baseline characteristics by cohort
| Measure |
Demographic Characteristics of the Patients
n=43 Participants
Demographic characteristics of the patients included and type of surgical procedures
|
|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
BMI
|
26.1 kg/m^2
n=5 Participants
|
|
Smoking status
Yes
|
18 Participants
n=5 Participants
|
|
Smoking status
No
|
25 Participants
n=5 Participants
|
|
ASA status
II
|
10 Participants
n=5 Participants
|
|
ASA status
III
|
26 Participants
n=5 Participants
|
|
ASA status
IV
|
7 Participants
n=5 Participants
|
|
Surgical procedure
Colorectal
|
24 Participants
n=5 Participants
|
|
Surgical procedure
Gastric
|
6 Participants
n=5 Participants
|
|
Surgical procedure
Small intestine
|
2 Participants
n=5 Participants
|
|
Surgical procedure
Liver
|
5 Participants
n=5 Participants
|
|
Surgical procedure
Pancreas
|
3 Participants
n=5 Participants
|
|
Surgical procedure
Multiple resection
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: NRS was assessed before and 30 minutes after each tramadol dose during first 24 postoperative hoursPopulation: NRS score was determinated only in awake patients
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.
Outcome measures
| Measure |
NRS Score Before Tramadol Application
n=43 Participants
Before administration of tramadol to all patients who were extubated an NRS score was determined
|
NRS Score After Tramadol Application
n=43 Participants
30 minutes after administration of tramadol to all patients who were extubated an NRS score was determined
|
NRS Before Tramadol - With Systemic Inflammation
NRS score in a patient who meet the criteria for systemic inflammation, before tramadol administration
|
NRS After Tramadol - With Systemic Inflammation
NRS score in a patient who meet the criteria for systemic inflammation, after tramadol administration
|
|---|---|---|---|---|
|
Analgesic Affect of Tramadol After Major Abdominal Surgery
1st assessment
|
7 Score on a scale
Interval 3.5 to 9.5
|
5 Score on a scale
Interval 4.25 to 6.0
|
—
|
—
|
|
Analgesic Affect of Tramadol After Major Abdominal Surgery
2nd assessment
|
5 Score on a scale
Interval 3.0 to 6.5
|
3 Score on a scale
Interval 1.0 to 5.0
|
—
|
—
|
|
Analgesic Affect of Tramadol After Major Abdominal Surgery
3rd assessment
|
4 Score on a scale
Interval 2.5 to 5.0
|
2 Score on a scale
Interval 1.0 to 3.0
|
—
|
—
|
|
Analgesic Affect of Tramadol After Major Abdominal Surgery
4th assessment
|
4 Score on a scale
Interval 2.0 to 5.0
|
2 Score on a scale
Interval 1.0 to 4.0
|
—
|
—
|
|
Analgesic Affect of Tramadol After Major Abdominal Surgery
5th assessment
|
3 Score on a scale
Interval 2.0 to 5.0
|
2 Score on a scale
Interval 0.0 to 3.0
|
—
|
—
|
PRIMARY outcome
Timeframe: NRS was assessed before and 30 minutes after each dose of tramadol in a first 24 postoperative hourPopulation: NRS was assessed only in awake patients
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.
Outcome measures
| Measure |
NRS Score Before Tramadol Application
n=28 Participants
Before administration of tramadol to all patients who were extubated an NRS score was determined
|
NRS Score After Tramadol Application
n=28 Participants
30 minutes after administration of tramadol to all patients who were extubated an NRS score was determined
|
NRS Before Tramadol - With Systemic Inflammation
n=15 Participants
NRS score in a patient who meet the criteria for systemic inflammation, before tramadol administration
|
NRS After Tramadol - With Systemic Inflammation
n=15 Participants
NRS score in a patient who meet the criteria for systemic inflammation, after tramadol administration
|
|---|---|---|---|---|
|
Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation
4th assessment
|
4 score on a scale
Interval 2.0 to 5.0
|
2.5 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 2.0 to 7.25
|
2 score on a scale
Interval 1.0 to 3.5
|
|
Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation
5th assessment
|
3 score on a scale
Interval 2.0 to 5.75
|
2 score on a scale
Interval 0.25 to 3.57
|
3 score on a scale
Interval 2.0 to 5.0
|
2 score on a scale
Interval 0.0 to 3.0
|
|
Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation
1st assessment
|
7 score on a scale
Interval 3.0 to 10.0
|
5 score on a scale
Interval 3.5 to 5.0
|
7 score on a scale
Interval 7.0 to 7.0
|
7 score on a scale
Interval 6.0 to 7.0
|
|
Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation
2nd assessment
|
5.5 score on a scale
Interval 3.57 to 7.25
|
3 score on a scale
Interval 1.0 to 4.25
|
4 score on a scale
Interval 3.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
|
Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation
3rd assessment
|
4 score on a scale
Interval 3.0 to 5.0
|
2 score on a scale
Interval 1.25 to 3.0
|
3 score on a scale
Interval 2.0 to 5.0
|
2 score on a scale
Interval 0.5 to 4.0
|
Adverse Events
Adverse Effect
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adverse Effect
n=43 participants at risk
Adverse effect of tramadol
|
|---|---|
|
Gastrointestinal disorders
Postoperative nausea and/or vomiting
|
37.2%
16/43 • Number of events 16 • 24 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place