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Completed

NCT Number: NCT02238340

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

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.

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Key information

Conditions

Surgery

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Servicio de Aestesiologia.Hospital "Dr Luis Ortega"

Porlamar, Nueva Esparta, 6301, Venezuela

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extended-release oxycodone

Drug

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

Extended- release Oxycodone

Drug

Ketoprofen

Drug

Other names: Both groups received ketoprofen

dipirone

Drug

Other names: Both groups received dipirone

Dexametasone

Drug

Other names: Both groups received dexametasone

Morphine IV (rescue)

Drug

Other names: Both groups received Morphine IV (rescue)

Primary outcomes

  1. Percents of patients with EVA < 4 to the alt of UCPA, and 6 , 18 postoperatory hours

    Time frame: 24 hours

Secondary outcomes

  1. Percents of patients with adverse events because of treatment

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Hospital Central Dr. Luis Ortega

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 12, 2014
Registry last updated
Sep 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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