The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine

Study Overview
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Brief Summary
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Intrathecal epinephrine has been known to increase the duration of spinal anesthesia, or increase the quality of anesthesia. However, there is still a controversy, and the mechanism of epinephrine is recently suggested as a modulator of pain information in the spinal cord. Therefore, the investigators try to investigate the dose sparing effect of intrathecal epinephrine for spinal anesthesia with bupivacaine.

Detailed Description
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For patient undergoing total knee replacement arthroplasty, patients injected intrathecally with bupivacaine 8 mg were compared with those with bupivacaine 8 mg with 25 mcg of epinephrine, bupivacaine 8 mg with 50 mcg of epinephrine, and those with bupivacaine 8 mg with 100 mcg of epinephrine. The investigators compared the characteristics of spinal anesthesia including the quality and complication of spinal anesthesia. The researchers investigated whether intrathecal dose of epinephrine can reduce bupivacaine requirement and this effect is dependent on the dose of epinephrine.

Official Title
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The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine for Spinal Anesthesia in Total Knee Replacement Arthroplasty

Conditions
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Spinal Anesthesia

Intervention / Treatment
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* Drug: Placebo
* Drug: epinephrine 25
* Drug: Epinephrine 50
* Drug: epinephrine 100
* Drug: Epi 200


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient undergoing total knee replacement arthroplasty Exclusion Criteria: patient with cardiac or pulmonary disease (ASA class III or more) patient undergone previous spine surgery patient undergoing revised knee replacement

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 |
| --- | --- |
| Placebo Comparator: Placebo<br>8 mg bupivacaine only | Drug: Placebo<br>* intrathecal 8 mg of bupivacaine only<br>* Other names: Epinephrine;|
| Active Comparator: Epi 25<br>8 mg of bupivacaine mixed with 25 mcg of epinephrine | Drug: epinephrine 25<br>* intrathecal 8 mg of bupivacaine mixed with 25 mcg of epinephrine<br>* Other names: Epinephrine;|
| Active Comparator: Epi 50<br>8 mg of bupivacaine mixed with 50 mcg of epinephrine | Drug: Epinephrine 50<br>* intrathecal 8 mg of bupivacaine mixed with 50 mcg of epinephrine<br>* Other names: Epinephrine;|
| Active Comparator: Epi 100<br>8 mg of bupivacaine mixed with 0.1 mg of epinephrine | Drug: epinephrine 100<br>* intrathecal 8 mg of bupivacaine mixed with 0.1 mg of epinephrine<br>* Other names: Epinephrine;|
| Active Comparator: Epi 200<br>intrathecal bupivacaine 8 mg with 200 mcg of epinephrine | Drug: Epi 200<br>* intrathecal bupivacaine 8 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 sensory level of spinal anesthesia, the quality of intraoperative analgesia | at 2, 5, 10, 20, and 30 min after the spinal injection and every 15 minutes thereafter until complete regression of spinal anesthesia. | every 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intrathecal epinephrine, duration of anesthesia, quality of anesthesia, intrathecal fentanyl