Oxycodone Extended-release in the Treatment of Perioperative Pain in Patients Undergoing Orthopaedic Surgery

Study Overview
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Brief Summary
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Inadequate control of acute postoperative pain (DAPO) brings deleterious consequences for the patient, including significant cardiovascular and respiratory complications. Apart from the human suffering that is undeniable pain. Schemes oral analgesia with opioids for the treatment of DAPO, have shown to be as or more effective than intravenous or epidural regimes, and less expensive. Comparing the effectiveness of 10 to 20 mgs of oxycodone sustained release for 12 hours before surgery, into two groups of 20 patients (O-10, O-20) undergoing orthopedic surgery, in a scheme involving multimodal ketoprofen, dipyrone metoclopramide and dexamethasone. Values were recorded visual analog scale (VAS)for pain at rest and effort, requirement for rescue intravenous morphine and incidence of side effects to the entry and exit of the PACU (T0, TE) and at 6 and 18 hours postoperatively (T6, T18),and patient satisfaction.

Official Title
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Oxycodone Extended-release in the Treatment of Perioperative Pain in Patients Undergoing Orthopaedic Surgery

Conditions
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Surgery

Intervention / Treatment
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* Drug: Extended-release oxycodone
* Drug: Extended- release Oxycodone
* Drug: ketoprofen
* Drug: dipirone
* Drug: dexametasone
* Drug: Morphine IV (rescue)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I and II patients between 18 and 60 years old, both sexes, undergoing elective orthopedic surgery. Exclusion Criteria: Use of psychotropic medication or illicit drug use Pregnancy Liver disease Opioid use History of postoperative nausea and vomiting Ileus Allergy or intolerance to any of the study drugs Physical or mental inability to use the pain scale, or any surgical complications.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extended-release oxycodone 10mgr<br>Extended-release oxycodone 10 mgrs , started 12 hours before orthopaedic surgery | Drug: Extended-release oxycodone<br>* 10 o 20 mgrs of extended-release oxycodone ,started 12 hours before orthopaedic surgery<br>Drug: Extended- release Oxycodone<br> <br> Drug: ketoprofen<br> <br> * Other names: Both groups received ketoprofen;Drug: dipirone<br> <br> * Other names: Both groups received dipirone;Drug: dexametasone<br> <br> * Other names: Both groups received dexametasone;Drug: Morphine IV (rescue)<br> <br> * Other names: Both groups received Morphine IV (rescue);|
| Experimental: Extended-release oxycodone 20 mgr<br>Extended-release oxycodone 20 mgr , started 12 hours before orthopaedic surgery | Drug: Extended-release oxycodone<br>* 10 o 20 mgrs of extended-release oxycodone ,started 12 hours before orthopaedic surgery<br>Drug: Extended- release Oxycodone<br> <br> Drug: ketoprofen<br> <br> * Other names: Both groups received ketoprofen;Drug: dipirone<br> <br> * Other names: Both groups received dipirone;Drug: dexametasone<br> <br> * Other names: Both groups received dexametasone;Drug: Morphine IV (rescue)<br> <br> * Other names: Both groups received Morphine IV (rescue);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percents of patients with EVA < 4 to the alt of UCPA, and 6 , 18 postoperatory hours |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percents of patients with adverse events because of treatment |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperatory pain, Oxycodone