Trial | NCT03434951  Report issue

Title

Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty
Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty, a Randomized Controlled Study

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    120
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.
Study Started
Nov 06
2017
Primary Completion
Sep 01
2019
Anticipated
Study Completion
Sep 01
2020
Anticipated
Last Update
Feb 15
2018

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)

Drug Placebo - Concentrate

Intrathecally administered saline solution 0,9% 0,1ml to match morphine volume

  • Other names: physiologic saline solution

Intrathecal morphine and bupivacaine Experimental

0,2mg intrathecal morphine and 12,5mg bupivacaine administered

Placebo Active Comparator

12,5mg bupivacaine and NaCl 0,9% to match the same volume administered

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
No Results Posted