Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty
1 other identifier
interventional
120
1 country
1
Brief Summary
Double-blinded randomized control study investigating intrathecal morphine as an additive to spinal anesthesia in patients undergoing elective total knee arthroplasty. The investigators aim to include a total of 120 patients, randomized to two equal groups. Participants in the intervention group are administered intrathecal 0,2mg morphine and 12,5mg bupivacaine for spinal anaesthesia. Participants in the placebo group are administered 12.5mg bupivacaine and saline to match the volume of intervention goup. Primary end points are opioid consumption and possible adverse effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2017
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 6, 2017
CompletedFirst Submitted
Initial submission to the registry
December 10, 2017
CompletedFirst Posted
Study publicly available on registry
February 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedFebruary 15, 2018
February 1, 2018
1.8 years
December 10, 2017
February 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
intravenous oxycodone consumption
Cumulative postoperative consumption
48 hours
Secondary Outcomes (3)
Adverse effects of 0,2mg intrathecal morphine
48 hours
Mobilization time
48 hours
Patient satisfaction
28 days
Study Arms (2)
Intrathecal morphine and bupivacaine
EXPERIMENTAL0,2mg intrathecal morphine and 12,5mg bupivacaine administered
Placebo
ACTIVE COMPARATOR12,5mg bupivacaine and NaCl 0,9% to match the same volume administered
Interventions
Intrathecally administered 12,5mg bupivacaine for spinal anaesthesia
Intrathecally administered morphine 0,2mg (2mg/ml, 0,1ml)
Intrathecally administered saline solution 0,9% 0,1ml to match morphine volume
Eligibility Criteria
You may qualify if:
- elective primary total knee arthroplasty
- ASA I-III
- written consent
You may not qualify if:
- rearthroplasty
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Carelia Central Hospital
Lappeenranta, 53130, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Seppo Mustola, MD, PhD
South Carelia Central Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- SRN/ Anesthesia
Study Record Dates
First Submitted
December 10, 2017
First Posted
February 15, 2018
Study Start
November 6, 2017
Primary Completion
September 1, 2019
Study Completion
September 1, 2020
Last Updated
February 15, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share