Trial | NCT02238340  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
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.
Study Started
Mar 31
2012
Primary Completion
Aug 31
2012
Study Completion
Sep 30
2012
Last Update
Sep 12
2014
Estimate

Drug Extended-release oxycodone

10 o 20 mgrs of extended-release oxycodone ,started 12 hours before orthopaedic surgery

Drug Extended- release Oxycodone

Drug ketoprofen

  • Other names: Both groups received ketoprofen

Drug dipirone

  • Other names: Both groups received dipirone

Drug dexametasone

  • Other names: Both groups received dexametasone

Drug Morphine IV (rescue)

  • Other names: Both groups received Morphine IV (rescue)

Extended-release oxycodone 10mgr Experimental

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

Extended-release oxycodone 20 mgr Experimental

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

Criteria 

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.
No Results Posted