Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty, a Randomized Controlled Study
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- intravenous oxycodone consumption
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •elective primary total knee arthroplasty
- •ASA I-III
- •written consent
Exclusion Criteria
- •rearthroplasty
- •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
Arms & Interventions
Intrathecal morphine and bupivacaine
0,2mg intrathecal morphine and 12,5mg bupivacaine administered
Intervention: Bupivacaine Hydrochloride, Spinal (Drug)
Intrathecal morphine and bupivacaine
0,2mg intrathecal morphine and 12,5mg bupivacaine administered
Intervention: Morphine hydrochloride, Spinal (Drug)
Placebo
12,5mg bupivacaine and NaCl 0,9% to match the same volume administered
Intervention: Bupivacaine Hydrochloride, Spinal (Drug)
Placebo
12,5mg bupivacaine and NaCl 0,9% to match the same volume administered
Intervention: Placebo - Concentrate (Drug)
Outcomes
Primary Outcomes
intravenous oxycodone consumption
Time Frame: 48 hours
Cumulative postoperative consumption
Secondary Outcomes
- Adverse effects of 0,2mg intrathecal morphine(48 hours)
- Mobilization time(48 hours)
- Patient satisfaction(28 days)
Investigators
Susanna Niinimäki
SRN/ Anesthesia
South Carelia Central Hospital