Oxycodone Extended-release in the Treatment of Perioperative Pain in Patients Undergoing Orthopaedic Surgery
- Conditions
- Surgery
- Interventions
- Drug: Extended- release OxycodoneDrug: dipironeDrug: dexametasone
- Registration Number
- NCT02238340
- Lead Sponsor
- Hospital Central Dr. Luis Ortega
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- ASA I and II patients between 18 and 60 years old, both sexes, undergoing elective orthopedic surgery.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Extended-release oxycodone 10mgr Morphine IV (rescue) Extended-release oxycodone 10 mgrs , started 12 hours before orthopaedic surgery Extended-release oxycodone 10mgr Extended-release oxycodone Extended-release oxycodone 10 mgrs , started 12 hours before orthopaedic surgery Extended-release oxycodone 10mgr dipirone Extended-release oxycodone 10 mgrs , started 12 hours before orthopaedic surgery Extended-release oxycodone 10mgr Extended- release Oxycodone Extended-release oxycodone 10 mgrs , started 12 hours before orthopaedic surgery Extended-release oxycodone 10mgr dexametasone Extended-release oxycodone 10 mgrs , started 12 hours before orthopaedic surgery Extended-release oxycodone 20 mgr Extended- release Oxycodone Extended-release oxycodone 20 mgr , started 12 hours before orthopaedic surgery Extended-release oxycodone 20 mgr dipirone Extended-release oxycodone 20 mgr , started 12 hours before orthopaedic surgery Extended-release oxycodone 20 mgr dexametasone Extended-release oxycodone 20 mgr , started 12 hours before orthopaedic surgery Extended-release oxycodone 20 mgr Morphine IV (rescue) Extended-release oxycodone 20 mgr , started 12 hours before orthopaedic surgery Extended-release oxycodone 20 mgr Extended-release oxycodone Extended-release oxycodone 20 mgr , started 12 hours before orthopaedic surgery Extended-release oxycodone 20 mgr ketoprofen Extended-release oxycodone 20 mgr , started 12 hours before orthopaedic surgery Extended-release oxycodone 10mgr ketoprofen Extended-release oxycodone 10 mgrs , started 12 hours before orthopaedic surgery
- Primary Outcome Measures
Name Time Method Percents of patients with EVA < 4 to the alt of UCPA, and 6 , 18 postoperatory hours 24 hours
- Secondary Outcome Measures
Name Time Method Percents of patients with adverse events because of treatment 24 hours
Trial Locations
- Locations (1)
Servicio de Aestesiologia.Hospital "Dr Luis Ortega"
🇻🇪Porlamar, Nueva Esparta, Venezuela