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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02238340

Enrollment

Registered

2014-09-12

Start date

2012-03-31

Completion date

2012-09-30

Last updated

2014-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Keywords

Postoperatory pain, Oxycodone

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.

Interventions

DRUGExtended-release oxycodone

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

DRUGExtended- release Oxycodone

DRUGketoprofen

DRUGdipirone

DRUGdexametasone

DRUGMorphine IV (rescue)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame
Percents of patients with EVA < 4 to the alt of UCPA, and 6 , 18 postoperatory hours	24 hours

Secondary

Measure	Time frame
Percents of patients with adverse events because of treatment	24 hours

Countries

Venezuela

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026