Pain
Conditions
Brief summary
Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a classical intravenous protocol with paracetamol and tramadol. Second is an oral protocol with Zaldiar (combination of paracetamol and tramadol).
Detailed description
Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a classical intravenous protocol with paracetamol and tramadol. This is the classical approach. Second is an oral protocol with Zaldiar (combination of paracetamol and tramadol). This is the new approach.
Interventions
DRUGZaldiar
Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)
DRUGParacetamol-Tramadol
Postoperative analgesia with intravenous Paracetamol and Tramadol
Sponsors
Astes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients incoming for inguinal hernia repair
Exclusion criteria
* Preoperative abuse of analgesics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Pain | In recovery room | Difference between groups in term of analgesia (as measured by Visual Analog Scale: VAS). The VAS range are between 0 and 10. A worse outcome was defined as VAS \> 4. The VAS use units on a scale. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group Z Postoperative Analgesia with Zaldiar
Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol) | 24 |
| Group PT Postoperative Analgesia with Paracetamol-Tramadol
Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol | 27 |
| Total | 51 |
Baseline characteristics
| Characteristic | Group PT | Group Z | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 10 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 14 Participants | 34 Participants |
| Age, Continuous | 62.41 years STANDARD_DEVIATION 14.51 | 57.08 years STANDARD_DEVIATION 16.42 | 57.19 years STANDARD_DEVIATION 15.29 |
| Region of Enrollment Belgium | 27 participants | 24 participants | 51 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 24 Participants | 21 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 27 |
| other Total, other adverse events | 0 / 24 | 0 / 27 |
| serious Total, serious adverse events | 0 / 24 | 0 / 27 |
Outcome results
Primary
Acute Pain
Difference between groups in term of analgesia (as measured by Visual Analog Scale: VAS). The VAS range are between 0 and 10. A worse outcome was defined as VAS \> 4. The VAS use units on a scale.
Time frame: In recovery room
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Group Z | Acute Pain | 1.5 units on a scale | Standard Deviation 1.28 |
| Group PT | Acute Pain | 1.74 units on a scale | Standard Deviation 1.86 |