Intrathecal Morphine and Fentanyl for Knee Arthroplasty

Study Overview
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Brief Summary
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This study is planned to investigate the efficacy of combined infusion of intrathecal morphine and fentanyl in patients undergoing total knee arthroplasty.

Official Title
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Influence of Combined Intrathecal Morphine and Fentanyl in Patients Undergoing Total Knee Arthroplasty

Conditions
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Knee Arthroplasty

Intervention / Treatment
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* Drug: Intrathecal morphine
* Drug: Intrathecal fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled total knee replacement under spinal anesthesia ASA I-III Exclusion Criteria: Coagulopathy Heart disease Liver disease Kidney disease Infection Psychological disorder Allergy to bupivacaine Allergy to morphine Allergy to fentanyl Inability to use patient-controlled analgesic device Opioids due to chronic pain

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intrathecal fentanyl<br> | Drug: Intrathecal fentanyl<br>* Intrathecal fentanyl 25 mcg will be injected.<br>|
| Active Comparator: intrathecal morphine<br> | Drug: Intrathecal morphine<br>* Intrathecal morphine 100 mcg will be injected.<br>|
| Experimental: intrathecal morphine and fentantyl<br> | Drug: Intrathecal morphine<br>* Intrathecal morphine 100 mcg will be injected.<br>Drug: Intrathecal fentanyl<br>* Intrathecal fentanyl 25 mcg will be injected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain scores at 6 hour postoperatively | Postoperative pain scores will be measured using visual-analogue scale (0:no pain, 10: worst imaginable pain). | At 6 hour postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain scores at 12 and 24 hour postoperatively | Postoperative pain scores will be measured using visual-analogue scale (0:no pain, 10: worst imaginable pain). | At 12 and 24 hour postoperatively | 
| Patient-controlled analgesic device requirements | The requirements of patient-controlled analgesic device will be measured. Morphine will be used for patient-controlled analgesic device. Total dose of morphine used at 6, 12, and 24 hour postoperatively will be measured. | At 6, 12, and 24 hour postoperatively | 
| Number of participants with nausea |  | At 6, 12, and 24 hour postoperatively | 
| Number of participants with vomiting |  | At 6, 12, and 24 hour postoperatively | 
| Number of participants with pruritus |  | At 6, 12, and 24 hour postoperatively | 
| Number of participants with respiratory depression |  | At 6, 12, and 24 hour postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal anesthesia, morphine, fentanyl, pain, knee