PainNCT02087202
Hyperalgesia and NMDA Receptor Antagonist
A study testing Magnesium Sulfate and ketamine in people with Pain, run by Seoul National University Bundang Hospital.
Trial summary
NMDA receptor is administered and postoperative remote hyperalgesia is investigated. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain
- What is being tested?
- Magnesium Sulfate and ketamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Jul 2014
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA1-2
Who cannot join
- contraindication to the study drugs
About this study
NMDA receptor is administered and postoperative remote hyperalgesia is investigated.
Read the detailed description
NMDA receptor is adminstered and postoperative tertiary hyperalgesia is investigated.
QST and pain measures for remote hyperalgesia are compared between control and magnesium or ketamine group.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
magnesium sulfate is added to the patients
ketamineDrug
ketamine is added to the patients.
| Study group | Role | What they receive |
|---|---|---|
| magnesium | Experimental | magnesium is added perioperatively to those patients undergoing staged total knee arthroplasty and other surgeries. Receives: Drug: Magnesium Sulfate |
| ketamine | Experimental | ketamine is administered to those patients undergoing stated TKA and other operations. Receives: Drug: ketamine |
| control | Placebo comparator | normal saline (placebo) is administered to the patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
pain (QST and pain measures )until 1 month from the end of the operation
Measured: until 1 month from the end of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Mihyun, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087202
- Sponsor's protocol ID
- hyperalgesia
- Status last verified
- Mar 2014
- First submitted
- 12 Mar 2014
- Last updated
- 14 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperalgesia and NMDA Receptor Antagonist
- ClinicalTrials.gov ID
- NCT02087202
- Acronym / sponsor ID
- hyperalgesia
- Conditions
- Pain
- Keywords
- pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 14 Mar 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.
NMDA receptor is administered and postoperative remote hyperalgesia is investigated.
Detailed description
NMDA receptor is adminstered and postoperative tertiary hyperalgesia is investigated.
QST and pain measures for remote hyperalgesia are compared between control and magnesium or ketamine group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| magnesium | Experimental | Drug: Magnesium Sulfatemagnesium is added perioperatively to those patients undergoing staged total knee arthroplasty and other surgeries. |
| ketamine | Experimental | Drug: ketamineketamine is administered to those patients undergoing stated TKA and other operations. |
| control | Placebo comparator | –normal saline (placebo) is administered to the patients. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA1-2
Key exclusion criteria (1 listed)
- contraindication to the study drugs
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 |
|---|---|---|
| Magnesium Sulfatemagnesium sulfate is added to the patients | Drug | magnesium |
| ketamineketamine is added to the patients. | Drug | ketamine |
Primary outcome
pain
Time frame: until 1 month from the end of the operation
pain (QST and pain measures )until 1 month from the end of the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Sulfate and ketamine in people with Pain, run by Seoul National University Bundang Hospital.
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: status not confirmed, as of the sponsor's last update on 14 Mar 2014. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
pain (time frame: until 1 month from the end of the operation). 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 14 Mar 2014.