NCT02087202

Brief Summary

NMDA receptor is administered and postoperative remote hyperalgesia is investigated.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable pain

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

March 14, 2014

Status Verified

March 1, 2014

Enrollment Period

4 months

First QC Date

March 12, 2014

Last Update Submit

March 12, 2014

Conditions

Pain

Keywords

pain

Outcome Measures

Primary Outcomes (1)

  • pain

    pain (QST and pain measures )until 1 month from the end of the operation

    until 1 month from the end of the operation

Study Arms (3)

magnesium

EXPERIMENTAL

magnesium is added perioperatively to those patients undergoing staged total knee arthroplasty and other surgeries.

Drug: Magnesium Sulfate

ketamine

EXPERIMENTAL

ketamine is administered to those patients undergoing stated TKA and other operations.

Drug: ketamine

control

PLACEBO COMPARATOR

normal saline (placebo) is administered to the patients.

Interventions

Magnesium SulfateDRUG

magnesium sulfate is added to the patients

magnesium
ketamineDRUG

ketamine is added to the patients.

ketamine

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA1-2

You may not qualify if:

  • contraindication to the study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Interventions

Magnesium SulfateKetamine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

March 12, 2014

First Posted

March 14, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

March 14, 2014

Record last verified: 2014-03