General Surgery
Conditions
Keywords
Postoperative analgesia, tramadol, intensive care unit
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.
Interventions
None listed
Sponsors
Osijek University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Croatia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Demographic Characteristics of the Patients Demographic characteristics of the patients included and type of surgical procedures | 43 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not extubated within 24 h postoperatively | 3 |
| Overall Study | Protocol Violation | 4 |
Baseline characteristics
| Characteristic | Demographic Characteristics of the Patients |
|---|---|
| Age, Continuous | 67 years |
| ASA status II | 10 Participants |
| ASA status III | 26 Participants |
| ASA status IV | 7 Participants |
| BMI | 26.1 kg/m^2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 43 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 28 Participants |
| Smoking status No | 25 Participants |
| Smoking status Yes | 18 Participants |
| Surgical procedure Colorectal | 24 Participants |
| Surgical procedure Gastric | 6 Participants |
| Surgical procedure Liver | 5 Participants |
| Surgical procedure Multiple resection | 3 Participants |
| Surgical procedure Pancreas | 3 Participants |
| Surgical procedure Small intestine | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 43 |
| other Total, other adverse events | 16 / 43 |
| serious Total, serious adverse events | 0 / 43 |
Outcome results
Primary
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.
Time frame: NRS was assessed before and 30 minutes after each tramadol dose during first 24 postoperative hours
Population: NRS score was determinated only in awake patients
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| NRS Score Before Tramadol Application | Analgesic Affect of Tramadol After Major Abdominal Surgery | 2nd assessment | 5 Score on a scale |
| NRS Score Before Tramadol Application | Analgesic Affect of Tramadol After Major Abdominal Surgery | 4th assessment | 4 Score on a scale |
| NRS Score Before Tramadol Application | Analgesic Affect of Tramadol After Major Abdominal Surgery | 3rd assessment | 4 Score on a scale |
| NRS Score Before Tramadol Application | Analgesic Affect of Tramadol After Major Abdominal Surgery | 5th assessment | 3 Score on a scale |
| NRS Score Before Tramadol Application | Analgesic Affect of Tramadol After Major Abdominal Surgery | 1st assessment | 7 Score on a scale |
| NRS Score After Tramadol Application | Analgesic Affect of Tramadol After Major Abdominal Surgery | 5th assessment | 2 Score on a scale |
| NRS Score After Tramadol Application | Analgesic Affect of Tramadol After Major Abdominal Surgery | 1st assessment | 5 Score on a scale |
| NRS Score After Tramadol Application | Analgesic Affect of Tramadol After Major Abdominal Surgery | 2nd assessment | 3 Score on a scale |
| NRS Score After Tramadol Application | Analgesic Affect of Tramadol After Major Abdominal Surgery | 3rd assessment | 2 Score on a scale |
| NRS Score After Tramadol Application | Analgesic Affect of Tramadol After Major Abdominal Surgery | 4th assessment | 2 Score on a scale |
Primary
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.
Time frame: NRS was assessed before and 30 minutes after each dose of tramadol in a first 24 postoperative hour
Population: NRS was assessed only in awake patients
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| NRS Score Before Tramadol Application | Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation | 2nd assessment | 5.5 score on a scale |
| NRS Score Before Tramadol Application | Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation | 1st assessment | 7 score on a scale |
| NRS Score Before Tramadol Application | Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation | 3rd assessment | 4 score on a scale |
| NRS Score Before Tramadol Application | Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation | 5th assessment | 3 score on a scale |
| NRS Score Before Tramadol Application | Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation | 4th assessment | 4 score on a scale |
| NRS Score After Tramadol Application | Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation | 4th assessment | 2.5 score on a scale |
| NRS Score After Tramadol Application | Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation | 1st assessment | 5 score on a scale |
| NRS Score After Tramadol Application | Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation | 2nd assessment | 3 score on a scale |
| NRS Score After Tramadol Application | Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation | 3rd assessment | 2 score on a scale |
| NRS Score After Tramadol Application | Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation | 5th assessment | 2 score on a scale |
| NRS Before Tramadol - With Systemic Inflammation | Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation | 5th assessment | 3 score on a scale |
| NRS Before Tramadol - With Systemic Inflammation | Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation | 3rd assessment | 3 score on a scale |
| NRS Before Tramadol - With Systemic Inflammation | Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation | 4th assessment | 3 score on a scale |
| NRS Before Tramadol - With Systemic Inflammation | Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation | 1st assessment | 7 score on a scale |
| NRS Before Tramadol - With Systemic Inflammation | Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation | 2nd assessment | 4 score on a scale |
| NRS After Tramadol - With Systemic Inflammation | Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation | 4th assessment | 2 score on a scale |
| NRS After Tramadol - With Systemic Inflammation | Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation | 2nd assessment | 2 score on a scale |
| NRS After Tramadol - With Systemic Inflammation | Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation | 3rd assessment | 2 score on a scale |
| NRS After Tramadol - With Systemic Inflammation | Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation | 1st assessment | 7 score on a scale |
| NRS After Tramadol - With Systemic Inflammation | Examine Differences in the Analgesic Effect of Tramadol Between Patients With and Without Postoperative Systemic Inflammation | 5th assessment | 2 score on a scale |