Elective Laproscopic Bilateral Inguinal HerniaPhase 4NCT00480142
Controlled Release of Oxycodone 10 mg In Pre-Medication For The Post Operative Analgesia In Elective Laparoscopic Bilateral Inguinal Hernia And Elective Laparoscopic Cholecystectomy
A Phase 4 study testing Oxycodone 10 mg in people with Elective Laproscopic Bilateral Inguinal Hernia and Elective Laproscopic Cholecystectomy, run by Kaplan Medical Center.
Trial summary
A Prospective Double Blind RCT: Controlled Release Oxycodone 10 mg On a 12 h Dosing Schedule Started With The Premedication ,Placebo Controlled Study,On Post Operative Analgesia Management in Laparoscopic Cholecystectomy and Laparoscopic Bilateral Inguinal Hernia (BIH). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Elective Laproscopic Bilateral Inguinal Hernia, Elective Laproscopic Cholecystectomy
- What is being tested?
- Oxycodone 10 mg
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Jul 2008
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Local ethic committee approval
- Written informed consent
- ASA physical status I-III, scheduled for elective laparoscopic cholecystectomy and elective laparoscopic BIH
Who cannot join
- Difficulty in communication
- Allergy to oxycodone and/or morphine
- Allergy to local anesthetic
- History of alcohol and substance abuse
- Treated depression
- Chronic use of opioid or tramadol or NSAIDS
Show all 14Show fewer
- Pregnancy
- Obstructive sleep apnea
- Anticipated fiber optic intubation
- Severe hepatic or renal impairment
- Weight <50 kg or > 100 kg
- Conversion to laparotomy
- Patient extubated in PACU.
- Any prior abdominal surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Controlled Release of Oxycodone 10 mg In Pre-Medication For The Post Operative Analgesia In Elective Laparoscopic Bilateral Inguinal Hernia And Elective Laparoscopic Cholecystectomy : Prospective Double Blind, Randomized, Placebo-Controlled Study
A Prospective Double Blind RCT: Controlled Release Oxycodone 10 mg On a 12 h Dosing Schedule Started With The Premedication ,Placebo Controlled Study,On Post Operative Analgesia Management in Laparoscopic Cholecystectomy and Laparoscopic Bilateral Inguinal Hernia (BIH).
CRO is indicated for the management of moderate to severe pain when a continuous,around the clock analgesic is needed for an extended period of time.Its safety and efficacy in the first 12-24 hours post operative has not been established.
- Being tested
- Oxycodone 10 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone 10 mgDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2007 (estimated)
- Study startJul 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Laproscopic Bilateral Inguinal HerniaStudies 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
- Double blind
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- patricia grosman, MD, Principal investigator, Israel: Kaplan Hospital, Clalit Health ServiceEli Mavor, MD, Study chair, Israel:Clalit Health Serviceoscar liphshitz, MD, Study director, Isreal: Kaplan: Clalit Health ServiceBella Almog, R.N MA, Study director, Israel: Kaplan: Clalit Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480142
- Sponsor's protocol ID
- kmc070012CTIL
- Status last verified
- May 2007
- First submitted
- 26 Apr 2007
- Last updated
- 6 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Release of Oxycodone 10 mg In Pre-Medication For The Post Operative Analgesia In Elective Laparoscopic Bilateral Inguinal Hernia And Elective Laparoscopic Cholecystectomy : Prospective Double Blind, Randomized, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT00480142
- Acronym / sponsor ID
- kmc070012CTIL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Study start
- Jul 2007
- Study completion
- Jul 2008
- First posted
- 30 May 2007 (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.
A Prospective Double Blind RCT: Controlled Release Oxycodone 10 mg On a 12 h Dosing Schedule Started With The Premedication ,Placebo Controlled Study,On Post Operative Analgesia Management in Laparoscopic Cholecystectomy and Laparoscopic Bilateral Inguinal Hernia (BIH).
CRO is indicated for the management of moderate to severe pain when a continuous,around the clock analgesic is needed for an extended period of time.Its safety and efficacy in the first 12-24 hours post operative has not been established.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Local ethic committee approval
- Written informed consent
- ASA physical status I-III, scheduled for elective laparoscopic cholecystectomy and elective laparoscopic BIH
Key exclusion criteria (14 listed)
- Difficulty in communication
- Allergy to oxycodone and/or morphine
- Allergy to local anesthetic
- History of alcohol and substance abuse
- Treated depression
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 |
|---|---|---|
| Oxycodone 10 mg | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2007.
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.
patricia grosman, MD principal investigator
Israel: Kaplan Hospital, Clalit Health Service
Eli Mavor, MD study chair
Israel:Clalit Health Service
oscar liphshitz, MD study director
Isreal: Kaplan: Clalit Health Service
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxycodone 10 mg in people with Elective Laproscopic Bilateral Inguinal Hernia and Elective Laproscopic Cholecystectomy, run by Kaplan Medical Center.
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 3 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 6 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oscar Liphshitz, MD (0524782736, liphshitz@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 6 Jun 2007.