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

September 11, 2014 updated by: Beatriz Arismendi Gómez, Hospital Central Dr. Luis Ortega
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Venezuela
    • Nueva Esparta
      • Porlamar, Nueva Esparta, Venezuela, 6301
        • Servicio de Aestesiologia.Hospital "Dr Luis Ortega"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Extended-release oxycodone 10mgr
Extended-release oxycodone 10 mgrs , started 12 hours before orthopaedic surgery
Drug: ketoprofen
Other Names:
  • Both groups received ketoprofen
Drug: Extended-release oxycodone
10 o 20 mgrs of extended-release oxycodone ,started 12 hours before orthopaedic surgery
Drug: Extended- release Oxycodone
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)
Experimental: Extended-release oxycodone 20 mgr
Extended-release oxycodone 20 mgr , started 12 hours before orthopaedic surgery
Drug: ketoprofen
Other Names:
  • Both groups received ketoprofen
Drug: Extended-release oxycodone
10 o 20 mgrs of extended-release oxycodone ,started 12 hours before orthopaedic surgery
Drug: Extended- release Oxycodone
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Percents of patients with adverse events because of treatment
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Central Dr. Luis Ortega

Investigators

  • Principal Investigator: Beatriz S Arismendi Gomez, MD, Sociedad Venezolana de Anestesiologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

September 2, 2014

First Submitted That Met QC Criteria

September 11, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Estimate)

September 12, 2014

Last Update Submitted That Met QC Criteria

September 11, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Oxycodone

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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