Oxycodone Extended-release in the Treatment of Perioperative Pain in Patients Undergoing Orthopaedic Surgery
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 surgery
Started Mar 2012
Shorter than P25 for phase_4 surgery
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 2, 2014
CompletedFirst Posted
Study publicly available on registry
September 12, 2014
CompletedSeptember 12, 2014
September 1, 2014
5 months
September 2, 2014
September 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percents of patients with EVA < 4 to the alt of UCPA, and 6 , 18 postoperatory hours
24 hours
Secondary Outcomes (1)
Percents of patients with adverse events because of treatment
24 hours
Study Arms (2)
Extended-release oxycodone 10mgr
EXPERIMENTALExtended-release oxycodone 10 mgrs , started 12 hours before orthopaedic surgery
Extended-release oxycodone 20 mgr
EXPERIMENTALExtended-release oxycodone 20 mgr , started 12 hours before orthopaedic surgery
Interventions
10 o 20 mgrs of extended-release oxycodone ,started 12 hours before orthopaedic surgery
Eligibility Criteria
You may qualify if:
- ASA I and II patients between 18 and 60 years old, both sexes, undergoing elective orthopedic surgery.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Servicio de Aestesiologia.Hospital "Dr Luis Ortega"
Porlamar, Nueva Esparta, 6301, Venezuela
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beatriz S Arismendi Gomez, MD
Sociedad Venezolana de Anestesiologia
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medico Anestesiologo
Study Record Dates
First Submitted
September 2, 2014
First Posted
September 12, 2014
Study Start
March 1, 2012
Primary Completion
August 1, 2012
Study Completion
September 1, 2012
Last Updated
September 12, 2014
Record last verified: 2014-09