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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine Only | Placebo Comparator | The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc. |
|
| EPI25 group | Active Comparator | The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc. |
|
| EPI50 group | Active Comparator | The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc. |
|
| EPI75 group | Active Comparator | The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075 cc, and sterile saline 0.025%. |
|
| EPI100 group | Active Comparator | The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Only | Drug | The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Bolin, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37965771 | Derived | Wolla CD, Epperson TI, Woltz EM, Wolf BJ, Bolin ED. Prolongation of spinal duration by escalating doses of intrathecal epinephrine in lower limb arthroplasty. Pain Manag. 2023 Nov;13(11):647-654. doi: 10.2217/pmt-2023-0068. Epub 2023 Nov 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupivacaine Only | The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc. Bupivacaine Only: The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc. |
| FG001 | EPI25 Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| EPI25 | Drug | The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc. |
|
| EPI50 group | Drug | The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc |
|
| EPI75 group | Drug | The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075cc, and sterile saline 0.025%. |
|
| EPI100 group | Drug | The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc. |
|
The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc.
EPI25: The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc.
| FG002 | EPI50 Group | The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc. EPI50 group: The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc |
| FG003 | EPI75 Group | The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075 cc, and sterile saline 0.025%. EPI75 group: The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075cc, and sterile saline 0.025%. |
| FG004 | EPI100 Group | The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc EPI100 group: The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupivacaine Only | The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc. Bupivacaine Only: The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc. |
| BG001 | EPI25 Group | The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc. EPI25: The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc. |
| BG002 | EPI50 Group | The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc. EPI50 group: The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc |
| BG003 | EPI75 Group | The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075 cc, and sterile saline 0.025%. EPI75 group: The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075cc, and sterile saline 0.025%. |
| BG004 | EPI100 Group | The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc EPI100 group: The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Sensory Block | Duration of the sensory block at the T12 dermatome will be assessed in the post operative phase | Posted | Mean | Standard Deviation | hours | 12 hours |
|
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| Primary | Duration of Motor Block | (hip felxion) of the non operative leg | Posted | Mean | Standard Deviation | hours | 12 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bupivacaine Only | The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc. Bupivacaine Only: The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc. | 0 | 6 | 0 | 6 | ||
| EG001 | EPI25 Group | The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc. EPI25: The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc. | 0 | 6 | 0 | 6 | ||
| EG002 | EPI50 Group | The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc. EPI50 group: The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc | 0 | 6 | 0 | 6 | ||
| EG003 | EPI75 Group | The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075 cc, and sterile saline 0.025%. EPI75 group: The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075cc, and sterile saline 0.025%. | 0 | 6 | 0 | 6 | ||
| EG004 | EPI100 Group | The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc EPI100 group: The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc. | 0 | 6 | 0 | 6 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Bolin | Medical University of South Carolina | 8437922322 | bolin@musc.edu |
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG004 | EPI100 Group | The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc EPI100 group: The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc. |
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