Intrathecal Morphine for Unilateral Total Knee Arthroplasty

Study Overview
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Brief Summary
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This study evaluates postoperative numerical pain score and systemic opioid requirement within 48 hours for unilateral total knee arthroplasty. Comparing among 3 groups of intrathecal morphine; 0,50, 100 ug with multimodal analgesia.

Detailed Description
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Intrathecal opioid is effective postoperative analgesia for orthopedic lower extremity surgery. However there are some limitations such as nausea, vomiting, pruritus, dizziness. Nowadays multimodal analgesia is used in unilateral total knee arthroplasty include oral analgesic drugs, adductor canal block and local analgesia infiltration. This study evaluates whether intrathecal opioid should be added in the role of multimodal analgesia in total knee arthroplasty.

Official Title
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Efficacy and Side Effects of Intrathecal Morphine in Multimodal Analgesia for Unilateral Total Knee Arthroplasty

Conditions
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Primary Osteoarthritis of Knee Nos

Intervention / Treatment
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* Procedure: 50 ug IT morphine
* Procedure: 100 ug IT morphine
* Procedure: No IT morphine
* Drug: Morphine
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged more than 18 years old undergoing unilateral total knee arthroplasty American Society of Anesthesiologists physical status classification 1-3 Exclusion Criteria: Participants deny to enroll the study Allergy to local anesthetics, opioid and NSAIDs Hepatic disease Contraindication for neuraxial block or adductor canal block Uncontrolled cardiovascular disease Creatinine clearance less than 50 ml/min

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No IT morphine<br>Spinal block with 0.5% isobaric with no intrathecal morphine | Procedure: No IT morphine<br>* Spinal block with bupivacaine and intrathecal morphine 0 ug<br>Drug: Morphine<br>* intrathecal morphine<br>Drug: Bupivacaine<br>* 0.5 isobaric bupivacaine<br>|
| Experimental: 50 ug IT morphine<br>Spinal block with 0.5% isobaric with 50 ug intrathecal morphine | Procedure: 50 ug IT morphine<br>* Spinal block with bupivacaine and intrathecal morphine 50 ug<br>Drug: Morphine<br>* intrathecal morphine<br>Drug: Bupivacaine<br>* 0.5 isobaric bupivacaine<br>|
| Experimental: 100 ug IT morphine<br>Spinal block with 0.5% isobaric with 100 ug intrathecal morphine | Procedure: 100 ug IT morphine<br>* Spinal block with bupivacaine and intrathecal morphine 100 ug<br>Drug: Morphine<br>* intrathecal morphine<br>Drug: Bupivacaine<br>* 0.5 isobaric bupivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical rating scale | Numerical rating scale 0-10 | Within 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine requirement | Systemic morphine requirement | Within 48 hours | 
| Nausea vomiting | Incidence and severity of nausea and vomiting | Within 48 hours | 
| Pruritus | Incidence and severity of pruritus | Within 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrathecal morphine, total knee arthroplasty