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

NCT02238340 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-09-12

No results posted yet for this study

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.

Conditions

  • Surgery

Interventions

DRUG

Extended-release oxycodone

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

DRUG

Extended- release Oxycodone

DRUG

ketoprofen

DRUG

dipirone

DRUG

dexametasone

DRUG

Morphine IV (rescue)

Sponsors & Collaborators

  • Hospital Central Dr. Luis Ortega

    lead OTHER

Principal Investigators

  • Beatriz S Arismendi Gomez, MD · Sociedad Venezolana de Anestesiologia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-08-31
Completion
2012-09-30

Countries

  • Venezuela

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02238340 on ClinicalTrials.gov