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Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03434951
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Susanna Niinimäki, South Carelia Central Hospital

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Bupivacaine Hydrochloride, Spinal Drug: Morphine hydrochloride, Spinal Drug: Placebo - Concentrate Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty, a Randomized Controlled Study
Actual Study Start Date : November 6, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Intrathecal morphine and bupivacaine
0,2mg intrathecal morphine and 12,5mg bupivacaine administered
Drug: Bupivacaine Hydrochloride, Spinal
Intrathecally administered 12,5mg bupivacaine for spinal anaesthesia

Drug: Morphine hydrochloride, Spinal
Intrathecally administered morphine 0,2mg (2mg/ml, 0,1ml)

Active Comparator: Placebo
12,5mg bupivacaine and NaCl 0,9% to match the same volume administered
Drug: Bupivacaine Hydrochloride, Spinal
Intrathecally administered 12,5mg bupivacaine for spinal anaesthesia

Drug: Placebo - Concentrate
Intrathecally administered saline solution 0,9% 0,1ml to match morphine volume
Other Name: physiologic saline solution




Primary Outcome Measures :
  1. intravenous oxycodone consumption [ Time Frame: 48 hours ]
    Cumulative postoperative consumption


Secondary Outcome Measures :
  1. Adverse effects of 0,2mg intrathecal morphine [ Time Frame: 48 hours ]
    Possible nausea, vomiting, itching and respiratory depression

  2. Mobilization time [ Time Frame: 48 hours ]
    Assessing the time to ambulation

  3. Patient satisfaction [ Time Frame: 28 days ]
    Telephone interview 28 days after surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective primary total knee arthroplasty
  • ASA I-III
  • written consent

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434951


Contacts
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Contact: Susanna Niinimäki, BSc, SRN /Anesthesia +358406511388 susanna.niinimaki@eksote.fi
Contact: Seppo Mustola, MD, PhD +358447915832 seppo.mustola@eksote.fi

Locations
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Finland
South Carelia Central Hospital Recruiting
Lappeenranta, Finland, 53130
Contact: Susanna Niinimäki, BSc, SRN /Anesthesia    +358406511388    Susanna.niinimaki@eksote.fi   
Contact: MD, PhD         
Sponsors and Collaborators
South Carelia Central Hospital
Investigators
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Study Director: Seppo Mustola, MD, PhD South Carelia Central Hospital

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Responsible Party: Susanna Niinimäki, SRN/ Anesthesia, South Carelia Central Hospital
ClinicalTrials.gov Identifier: NCT03434951    
Other Study ID Numbers: KNEMO 01
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics