Arthroplasty, Replacement, HipKETAMINENCT00797264
Ketamine Associated With Morphine PCA After Total Hip Arthroplasty
A study testing Ketamine-Morphine, Morphine and Postoperative PCA of Ketamine and morphine in people with Arthroplasty, Replacement, Hip, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Ketamine (an analgesic drug often associated with morphine in the treatment of Opioid Induced Hyperalgesia) is often mixed in Morphine PCA syringe. We make the hypothesis that ketamine administrated separately via a continuous infusion, could induced a better analgesic effect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- Ketamine-Morphine, Morphine and Postoperative PCA of Ketamine and morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to Oct 2010
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- total hip arthroplasty
Who cannot join
- pre operative opioid administration
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'anesthesie-reanimation - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
About this study
Official title: Impact of the Route of Administration of Ketamine Associated With Morphine PCA on Analgesia After Total Hip Arthroplasty
Ketamine (an analgesic drug often associated with morphine in the treatment of Opioid Induced Hyperalgesia) is often mixed in Morphine PCA syringe. We make the hypothesis that ketamine administrated separately via a continuous infusion, could induced a better analgesic effect.
We will perform a randomised double blind study to determine the best infusion mode of intravenous ketamine, associated with morphine in PCA syringe or alone in continuous infusion.
Read the detailed description
Double blind study to determine the best infusion mode of intravenous ketamine, associated with morphine in PCA syringe or alone in continuous infusion
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- Ketamine-Morphine, Morphine, Postoperative PCA of Ketamine and morphine
- Keywords
- Ketamine, Morphine, PCA, Hyperalgesia, Nor-ketamine
- Medical subject headings
- Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine-MorphineDrug
Also called Ketamine pre and per operative, and morphine postoperative
Ketamine bolus preoperative and syringe pump peroperative, and morphine postoperative (PCA)
MorphineDrug
Bolus preoperative of NaCl and syringe pump peroperative of NaCl, and morphine postoperative (PCA)
Postoperative PCA of Ketamine and morphineDrug
Also called Ketamine Morphine
Bolus preoperative of NaCl and syringe pump peroperative of Ketamine, and morphine postoperative (PCA)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Ketamine pre and per operative, and morphine postoperative Receives: Drug: Ketamine-Morphine |
| B | Active comparator | NaCl pre and per operative, and morphine postoperative Receives: Drug: Morphine |
| C | Experimental | Ketamine and morphine postoperative Receives: Drug: Postoperative PCA of Ketamine and morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption in PACU and in hospitalisation room
Measured: at 24 and 48 hours
Secondary outcomes (3)
Postoperative Visual Analogic Score of pain
Measured: in Recovery Room, at 24 and 48 hours, in the ward
Postoperative Measure of mechanical hyperalgesia by Von Frey filament device
Measured: 24 and 48 hours in the ward
Postoperative measure Ketamine and Nor-Ketamine blood levels
Measured: at 24 and 48 hours in the ward
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe SITBON, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris Hôpital Bicêtre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797264
- Sponsor's protocol ID
- P060402
- Acronym
- KETAMINE
- Status last verified
- Apr 2013
- First submitted
- 24 Nov 2008
- Last updated
- 11 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Route of Administration of Ketamine Associated With Morphine PCA on Analgesia After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT00797264
- Acronym / sponsor ID
- KETAMINE / P060402
- Conditions
- Arthroplasty, Replacement, Hip
- Keywords
- Ketamine, Morphine, PCA, Hyperalgesia, Nor-ketamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 25 Nov 2008 (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.
Ketamine (an analgesic drug often associated with morphine in the treatment of Opioid Induced Hyperalgesia) is often mixed in Morphine PCA syringe. We make the hypothesis that ketamine administrated separately via a continuous infusion, could induced a better analgesic effect.
We will perform a randomised double blind study to determine the best infusion mode of intravenous ketamine, associated with morphine in PCA syringe or alone in continuous infusion.
Detailed description
Double blind study to determine the best infusion mode of intravenous ketamine, associated with morphine in PCA syringe or alone in continuous infusion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Ketamine-MorphineKetamine pre and per operative, and morphine postoperative |
| B | Active comparator | Drug: MorphineNaCl pre and per operative, and morphine postoperative |
| C | Experimental | Drug: Postoperative PCA of Ketamine and morphineKetamine and morphine postoperative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- total hip arthroplasty
Key exclusion criteria (1 listed)
- pre operative opioid administration
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 |
|---|---|---|
| Ketamine-MorphineAlso: Ketamine pre and per operative, and morphine postoperativeKetamine bolus preoperative and syringe pump peroperative, and morphine postoperative (PCA) | Drug | A |
| MorphineBolus preoperative of NaCl and syringe pump peroperative of NaCl, and morphine postoperative (PCA) | Drug | B |
| Postoperative PCA of Ketamine and morphineAlso: Ketamine MorphineBolus preoperative of NaCl and syringe pump peroperative of Ketamine, and morphine postoperative (PCA) | Drug | C |
Primary outcome
Morphine consumption in PACU and in hospitalisation room
Time frame: at 24 and 48 hours
3 secondary outcomes
Postoperative Visual Analogic Score of pain
Time frame: in Recovery Room, at 24 and 48 hours, in the ward
Postoperative Measure of mechanical hyperalgesia by Von Frey filament device
Time frame: 24 and 48 hours in the ward
Postoperative measure Ketamine and Nor-Ketamine blood levels
Time frame: at 24 and 48 hours in the ward
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 11 Apr 2013.
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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.
Philippe SITBON, MD principal investigator
Assistance Publique - Hôpitaux de Paris Hôpital Bicêtre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine-Morphine, Morphine and Postoperative PCA of Ketamine and morphine in people with Arthroplasty, Replacement, Hip, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 1 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 11 Apr 2013. 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 France. 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.
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?
Morphine consumption in PACU and in hospitalisation room (time frame: at 24 and 48 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 11 Apr 2013.