Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty
NCT ID: NCT03434951
Last Updated: 2018-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2017-11-06
2020-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Intrathecal morphine and bupivacaine
0,2mg intrathecal morphine and 12,5mg bupivacaine administered
Bupivacaine Hydrochloride, Spinal
Intrathecally administered 12,5mg bupivacaine for spinal anaesthesia
Morphine hydrochloride, Spinal
Intrathecally administered morphine 0,2mg (2mg/ml, 0,1ml)
Placebo
12,5mg bupivacaine and NaCl 0,9% to match the same volume administered
Bupivacaine Hydrochloride, Spinal
Intrathecally administered 12,5mg bupivacaine for spinal anaesthesia
Placebo - Concentrate
Intrathecally administered saline solution 0,9% 0,1ml to match morphine volume
Interventions
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Bupivacaine Hydrochloride, Spinal
Intrathecally administered 12,5mg bupivacaine for spinal anaesthesia
Morphine hydrochloride, Spinal
Intrathecally administered morphine 0,2mg (2mg/ml, 0,1ml)
Placebo - Concentrate
Intrathecally administered saline solution 0,9% 0,1ml to match morphine volume
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA I-III
* written consent
Exclusion Criteria
* ASA IV-V
* inadequate spoken finnish for reliable pain assessment
* Dementia or otherwise impaired cognition
* contraindication for any medication or substance used in survey protocol
* weight \<50kg or BMI ≥35 kg/m2
* preoperative SpO2 less than 93%
* clinical suspicion that subject can not use PCA adequately
* history of substance abuse or current excessive use of alcohol
* preoperative use of either pregabalin, gabapentin or strong opiates
18 Years
85 Years
ALL
No
Sponsors
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South Carelia Central Hospital
OTHER
Responsible Party
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Susanna Niinimäki
SRN/ Anesthesia
Principal Investigators
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Seppo Mustola, MD, PhD
Role: STUDY_DIRECTOR
South Carelia Central Hospital
Locations
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South Carelia Central Hospital
Lappeenranta, , Finland
Countries
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Central Contacts
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Facility Contacts
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MD, PhD
Role: backup
Other Identifiers
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KNEMO 01
Identifier Type: -
Identifier Source: org_study_id
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