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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02238340
• Other study ID #: Oxycodone
• Status: Completed
• Phase: Phase 4
• First received: September 2, 2014
• Last updated: September 11, 2014
• Start date: March 2012
• Est. completion date: September 2012

Study information

• Verified date: September 2014
• Source: Hospital Central Dr. Luis Ortega
• Contact: n/a
• Is FDA regulated: No
• Health authority: Venezuela: Instituto Venezolano de Los Seguros Sociales.
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Surgery

Intervention

Drug:
• Extended-release oxycodone
10 o 20 mgrs of extended-release oxycodone ,started 12 hours before orthopaedic surgery
• Extended- release Oxycodone

• ketoprofen

• dipirone

• dexametasone

• Morphine IV (rescue)

Locations

Country	Name	City	State
Venezuela	Servicio de Aestesiologia.Hospital "Dr Luis Ortega"	Porlamar	Nueva Esparta

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Central Dr. Luis Ortega

Country where clinical trial is conducted

Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percents of patients with EVA < 4 to the alt of UCPA, and 6 , 18 postoperatory hours		24 hours	Yes
Secondary	Percents of patients with adverse events because of treatment		24 hours	Yes