Phase 4
Completed N=200
Assessment and Prevention of Acute Post-herniotomy Pain
Source: ClinicalTrials.gov NCT01345162 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Analgesic Efficacy — 26.5; 32.3 percentage of patients with NRS≥4
Summary
The aim of the study is the assessment and management of Acute Post-herniotomy Pain using two different therapeutical protocols per os: ketorolac versus association of acetaminophene+tramadol.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Analgesic Efficacy |
26.5; 32.3 | — |
| SECONDARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
— | — |
| SECONDARY Difference in Recovering Daily Activity |
— | — |
| SECONDARY Assessment of Any Connections Between the Two Therapeutical Strategies and the Recurrence of Surgical Complications |
— | — |
| SECONDARY Development of Persistent Postoperative Pain |
— | — |
Eligibility Criteria
Inclusion Criteria
- Males and females over 18 years, under 80 years, scheduled for elective herniotomy
- Classification American Society of Anesthesiologists (ASA) I: without systemic disease
- Classification ASA II or III (mild systemic disease or severe systemic disease that limits the activity without invalidity).
- Patients with hernia typ 2, 3a, 3b (classification NYHUS (1993))
- Signed informed consent
Exclusion Criteria
- ASA III, IV
- Emergency surgery
- Recovery in intensive care unit after surgery
- habitual opioid consumption
- NSADs allergy
- cognitive or mental alterations
- coagulopathy
- piastrinemia < 100.000/mm3
Data sourced from ClinicalTrials.gov (NCT01345162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.