Evaluation of the Duration of Bupivacaine Spinal Block in Orthopedic Procedures With and Without Epinephrine Wash

Study Overview
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Brief Summary
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Bupivacaine spinal is commonly performed as the primary anesthetic for orthopedic procedures. In some cases the duration of the block is inadequate. An epinephrine wash is sometimes performed to prolong the duration of the block. The epinephrine wash may prolong the duration of the block, and if it does, to what extent?

Official Title
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Evaluation of the Duration of Bupivacaine Spinal Block as the Primary Anesthetic for Orthopedic Procedures With and Without Epinephrine Wash

Conditions
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Arthropathy of Hip, Arthropathy of Knee

Intervention / Treatment
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* Drug: Bupivacaine Only
* Drug: EPI25
* Drug: EPI50 group
* Drug: EPI75 group
* Drug: EPI100 group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Patients scheduled for total hip or knee replacement Exclusion Criteria: Patients taking anticoagulation Infection at or near the intended needle insertion site Patients with sacral decubitus ulcer at or near the intended needle insertion site aortic stenosis Complex spine anatomy ASA class greater than III Failed SAB as determined by the staff anesthesiologist

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Placebo Comparator: Bupivacaine Only<br>The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc. | Drug: Bupivacaine Only<br>* The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc.<br>|
| Active Comparator: EPI25 group<br>The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc. | Drug: EPI25<br>* The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc.<br>|
| Active Comparator: EPI50 group<br>The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc. | Drug: EPI50 group<br>* The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc<br>|
| Active Comparator: EPI75 group<br>The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075 cc, and sterile saline 0.025%. | Drug: EPI75 group<br>* The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075cc, and sterile saline 0.025%.<br>|
| Active Comparator: EPI100 group<br>The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc | Drug: EPI100 group<br>* The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Sensory Block | Duration of the sensory block at the T12 dermatome will be assessed in the post operative phase | 12 hours | 
| Duration of Motor Block | (hip felxion) of the non operative leg | 12 hours |