Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty

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.

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

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: Bupivacaine Hydrochloride, Spinal
* Drug: Morphine hydrochloride, Spinal
* Drug: Placebo - Concentrate


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intrathecal morphine and bupivacaine<br>0,2mg intrathecal morphine and 12,5mg bupivacaine administered | Drug: Bupivacaine Hydrochloride, Spinal<br>* Intrathecally administered 12,5mg bupivacaine for spinal anaesthesia<br>Drug: Morphine hydrochloride, Spinal<br>* Intrathecally administered morphine 0,2mg (2mg/ml, 0,1ml)<br>|
| Active Comparator: Placebo<br>12,5mg bupivacaine and NaCl 0,9% to match the same volume administered | Drug: Bupivacaine Hydrochloride, Spinal<br>* Intrathecally administered 12,5mg bupivacaine for spinal anaesthesia<br>Drug: Placebo - Concentrate<br>* Intrathecally administered saline solution 0,9% 0,1ml to match morphine volume<br>* Other names: physiologic saline solution;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intravenous oxycodone consumption | Cumulative postoperative consumption | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects of 0,2mg intrathecal morphine | Possible nausea, vomiting, itching and respiratory depression | 48 hours | 
| Mobilization time | Assessing the time to ambulation | 48 hours | 
| Patient satisfaction | Telephone interview 28 days after surgery | 28 days |