SurgeryPhase 4NCT02238340
Oxycodone Extended-release in the Treatment of Perioperative Pain in Patients Undergoing Orthopaedic Surgery
A Phase 4 study testing Extended-release oxycodone, Extended- release Oxycodone and ketoprofen in people with Surgery, run by Hospital Central Dr. Luis Ortega at 1 site in Venezuela.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Surgery
- What is being tested?
- Extended-release oxycodone, Extended- release Oxycodone and ketoprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteVenezuela
- Study dates
- Mar 2012to Sep 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I and II patients between 18 and 60 years old, both sexes, undergoing elective orthopedic surgery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Venezuela1 site
Servicio de Aestesiologia.Hospital "Dr Luis Ortega"
Porlamar, Nueva Esparta, 6301
About this study
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
- Being tested
- Extended-release oxycodone, Extended- release Oxycodone, ketoprofen, dipirone, dexametasone
- Keywords
- Postoperatory pain, Oxycodone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended-release oxycodoneDrug
10 o 20 mgrs of extended-release oxycodone ,started 12 hours before orthopaedic surgery
Extended- release OxycodoneDrug
ketoprofenDrug
Also called Both groups received ketoprofen
dipironeDrug
Also called Both groups received dipirone
dexametasoneDrug
Also called Both groups received dexametasone
Morphine IV (rescue)Drug
Also called Both groups received Morphine IV (rescue)
| Study group | Role | What they receive |
|---|---|---|
| Extended-release oxycodone 10mgr | Experimental | Extended-release oxycodone 10 mgrs , started 12 hours before orthopaedic surgery Receives: Drug: Extended-release oxycodone; Drug: Extended- release Oxycodone; Drug: ketoprofen; Drug: dipirone; Drug: dexametasone; Drug: Morphine IV (rescue) |
| Extended-release oxycodone 20 mgr | Experimental | Extended-release oxycodone 20 mgr , started 12 hours before orthopaedic surgery Receives: Drug: Extended-release oxycodone; Drug: Extended- release Oxycodone; Drug: ketoprofen; Drug: dipirone; Drug: dexametasone; Drug: Morphine IV (rescue) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percents of patients with EVA < 4 to the alt of UCPA, and 6 , 18 postoperatory hours
Measured: 24 hours
Secondary outcomes (1)
Percents of patients with adverse events because of treatment
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startMar 2012
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Central Dr. Luis Ortega
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beatriz Arismendi Gómez, Hospital Central Dr. Luis Ortega
- Investigators
- Beatriz S Arismendi Gomez, MD, Principal investigator, Sociedad Venezolana de Anestesiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238340
- Sponsor's protocol ID
- Oxycodone
- Status last verified
- Sep 2014
- First submitted
- 2 Sep 2014
- Last updated
- 12 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxycodone Extended-release in the Treatment of Perioperative Pain in Patients Undergoing Orthopaedic Surgery
- ClinicalTrials.gov ID
- NCT02238340
- Acronym / sponsor ID
- Oxycodone
- Conditions
- Surgery
- Keywords
- Postoperatory pain, Oxycodone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital Central Dr. Luis OrtegaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 12 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended-release oxycodone 10mgr | Experimental | Drug: Extended-release oxycodone, Drug: Extended- release Oxycodone, Drug: ketoprofen, Drug: dipirone, Drug: dexametasone, Drug: Morphine IV (rescue)Extended-release oxycodone 10 mgrs , started 12 hours before orthopaedic surgery |
| Extended-release oxycodone 20 mgr | Experimental | Drug: Extended-release oxycodone, Drug: Extended- release Oxycodone, Drug: ketoprofen, Drug: dipirone, Drug: dexametasone, Drug: Morphine IV (rescue)Extended-release oxycodone 20 mgr , started 12 hours before orthopaedic surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA I and II patients between 18 and 60 years old, both sexes, undergoing elective orthopedic surgery.
Key exclusion criteria (8 listed)
- Use of psychotropic medication or illicit drug use
- Pregnancy
- Liver disease
- Opioid use
- History of postoperative nausea and vomiting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended-release oxycodone10 o 20 mgrs of extended-release oxycodone ,started 12 hours before orthopaedic surgery | Drug | Extended-release oxycodone 10mgr, Extended-release oxycodone 20 mgr |
| Extended- release Oxycodone | Drug | Extended-release oxycodone 10mgr, Extended-release oxycodone 20 mgr |
| ketoprofenAlso: Both groups received ketoprofen | Drug | Extended-release oxycodone 10mgr, Extended-release oxycodone 20 mgr |
| dipironeAlso: Both groups received dipirone | Drug | Extended-release oxycodone 10mgr, Extended-release oxycodone 20 mgr |
| dexametasoneAlso: Both groups received dexametasone | Drug | Extended-release oxycodone 10mgr, Extended-release oxycodone 20 mgr |
| Morphine IV (rescue)Also: Both groups received Morphine IV (rescue) | Drug | Extended-release oxycodone 10mgr, Extended-release oxycodone 20 mgr |
Primary outcome
Percents of patients with EVA < 4 to the alt of UCPA, and 6 , 18 postoperatory hours
Time frame: 24 hours
1 secondary outcome
Percents of patients with adverse events because of treatment
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatriz S Arismendi Gomez, MD principal investigator
Sociedad Venezolana de Anestesiologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Extended-release oxycodone, Extended- release Oxycodone and ketoprofen in people with Surgery, run by Hospital Central Dr. Luis Ortega at 1 site in Venezuela.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Venezuela. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percents of patients with EVA < 4 to the alt of UCPA, and 6 , 18 postoperatory hours (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2014.