ED50 and ED95 of Intrathecal Bupivacaine With or Without Epinephrine for Total Knee Replacement Arthroplasty

Study Overview
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Brief Summary
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This prospective randomized double-blind dose-response study is aimed to investigate the ED50 and ED95 of intrathecal bupivacaine with or without epinephrine 100 mcg for total knee replacement arthroplasty.

Detailed Description
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Patients undergoing total knee replacement arthroplasty are randomly assigned to six bupivacaine dose group (6, 7, 8, 9, 10, 11 mg). Combined spinal-epidural anesthesia would be performed. The dose would be considered as successful if no epidural supplement was required during surgery. A probit analysis will be performed to calculate the ED50 and ED95 of intrathecal bupivacaine with or without epinephrine for total knee replacement arthroplasty. After these measurements, ED50 and ED95 of bupivacaine with epinephrine would be compared with those without epinephrine.

Official Title
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ED50 and ED95 of Intrathecal Bupivacaine With or Without Epinephrine for Total Knee Replacement Arthroplasty

Conditions
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Spinal Anesthesia, Total Knee Replacement Arthroplasty

Intervention / Treatment
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* Drug: intrathecal bupivacaine 6 mg with 100 mcg of epinephrine
* Drug: intrathecal bupivacaine 7 mg with 100 mcg of epinephrine
* Drug: intrathecal bupivacaine 8 mg with 100 mcg of epinephrine
* Drug: intrathecal bupivacaine 9 mg with 100 mcg of epinephrine
* Drug: intrathecal bupivacaine 10 mg with 100 mcg of epinephrine
* Drug: intrathecal bupivacaine 11 mg with epinephrine 100 mcg
* Drug: intrathecal bupivacaine 6 mg with 200 mcg of epinephrine
* Drug: intrathecal bupivacaine 7 mg with 200 mcg of epinephrine
* Drug: intrathecal bupivacaine 8 mg with 200 mcg of epinephrine
* Drug: intrathecal bupivacaine 9 mg with 200 mcg of epinephrine
* Drug: intrathecal bupivacaine 10 mg with 200 mcg of epinephrine
* Drug: intrathecal bupivacaine 11 mg with 200 mcg of epinephrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients with ASA class I or II scheduled for total knee replacement surgery Exclusion Criteria: Patients with previous spine surgery, diabetic and other neuropathy, skin infection at the site of injection, allergy to bupivacaine and other common contraindications for spinal anesthesia were excluded from this study.

Ages Eligible for Study
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Minimum Age: 40 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BPV6E1<br> | Drug: intrathecal bupivacaine 6 mg with 100 mcg of epinephrine<br>* intrathecal bupivacaine 6 mg with 100 mcg of epinephrine<br>* Other names: epinephrine;|
| Experimental: BPV7E1<br> | Drug: intrathecal bupivacaine 7 mg with 100 mcg of epinephrine<br>* intrathecal bupivacaine 7 mg with 100 mcg of epinephrine<br>* Other names: epinephrine;|
| Experimental: BPV8E1<br> | Drug: intrathecal bupivacaine 8 mg with 100 mcg of epinephrine<br>* intrathecal bupivacaine 8 mg with 100 mcg of epinephrine<br>* Other names: epinephrine;|
| Experimental: BPV9E1<br> | Drug: intrathecal bupivacaine 9 mg with 100 mcg of epinephrine<br>* intrathecal bupivacaine 9 mg with 100 mcg of epinephrine<br>* Other names: epinephrine;|
| Experimental: BPV10E1<br> | Drug: intrathecal bupivacaine 10 mg with 100 mcg of epinephrine<br>* intrathecal bupivacaine 10 mg with 100 mcg of epinephrine<br>* Other names: epinephrine;|
| Experimental: BPV11E1<br> | Drug: intrathecal bupivacaine 11 mg with epinephrine 100 mcg<br>* intrathecal bupivacaine 11 mg with epinephrine 100 mcg<br>* Other names: epinephrine;|
| Experimental: BPV6E2<br> | Drug: intrathecal bupivacaine 6 mg with 200 mcg of epinephrine<br>* intrathecal bupivacaine 6 mg with 200 mcg of epinephrine<br>* Other names: epinephrine;|
| Experimental: BPV7E2<br> | Drug: intrathecal bupivacaine 7 mg with 200 mcg of epinephrine<br>* intrathecal bupivacaine 7 mg with 200 mcg of epinephrine<br>* Other names: epinephrine;|
| Experimental: BPV8E2<br> | Drug: intrathecal bupivacaine 8 mg with 200 mcg of epinephrine<br>* intrathecal bupivacaine 8 mg with 200 mcg of epinephrine<br>* Other names: epinephrine;|
| Experimental: BPV9E2<br> | Drug: intrathecal bupivacaine 9 mg with 200 mcg of epinephrine<br>* intrathecal bupivacaine 9 mg with 200 mcg of epinephrine<br>* Other names: epinephrine;|
| Experimental: BPV10E2<br> | Drug: intrathecal bupivacaine 10 mg with 200 mcg of epinephrine<br>* intrathecal bupivacaine 10 mg with 200 mcg of epinephrine<br>* Other names: epinephrine;|
| Experimental: BPV11E2<br> | Drug: intrathecal bupivacaine 11 mg with 200 mcg of epinephrine<br>* intrathecal bupivacaine 11 mg with 200 mcg of epinephrine<br>* Other names: epinephrine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the success of anesthesia | The individual dose would be considered to be successful if no epidural supplement is required during surgery. | during the surgery (average two hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects of the various intrathecal bupivacaine dose | lowest systolic blood pressure, vasopressure requirements, nausea, vomitting | during surgery (average two hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal anesthesia, intrathecal bupivacaine, epinephrine, ED50, ED95