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

Hospital Central Dr. Luis Ortega

Status and phase: Completed; Phase 4

Conditions: Surgery

Treatments: Drug: ketoprofen; Drug: dipirone; Drug: Extended- release Oxycodone; Drug: Morphine IV (rescue); Drug: Extended-release oxycodone; Drug: dexametasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02238340

Oxycodone

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups

Extended-release oxycodone 10mgr

Experimental group

Description:

Extended-release oxycodone 10 mgrs , started 12 hours before orthopaedic surgery

Treatment:

Drug: dexametasone

Drug: Morphine IV (rescue)

Drug: Extended-release oxycodone

Drug: Extended- release Oxycodone

Drug: dipirone

Drug: ketoprofen

Extended-release oxycodone 20 mgr

Experimental group

Description:

Extended-release oxycodone 20 mgr , started 12 hours before orthopaedic surgery

Treatment:

Drug: dexametasone

Drug: Morphine IV (rescue)

Drug: Extended-release oxycodone

Drug: Extended- release Oxycodone

Drug: dipirone

Drug: ketoprofen