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The primary objectives of this study are to define the extent of dermatomal anesthesia and anatomical spread of injectate (as defined by MRI imaging) that is provided by an ESP block at the T5 level, using twenty milliliters of 0.5% ropivacaine.
The secondary objectives include: 1) the measurement of changes in hemodynamic parameters associated with the ESP block, 2) the duration of sensory effects provided by ropivacaine with or without epinephrine, 3) the venous plasma concentration of ropivacaine associated at various time intervals after completion of the ESP block.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine with Epinephrine | Active Comparator | Group RE will have 20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process. |
|
| Ropivacaine without Epinephrine | Active Comparator | Group R will have 20mL of 0.5% Ropivacaine without epinephrine injected at the left or right T5 transverse process. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | injection of 20mL of 0.5% Ropivacaine at the left or right T5 transverse process |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area of Dermatomal Sensory Loss at 20 Min | A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin | 20 minutes from the time of the ESP block |
| Area of Dermatomal Sensory Loss 60 Min | A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin | 60 minutes from the time of the ESP block |
| Area of Dermatomal Sensory Loss 120 Min | A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin | 120 minutes from the time of the ESP block |
| Area of Dermatomal Sensory Loss at 240 Min | A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin | 240 minutes from the time of the ESP block |
| Area of Dermatomal Sensory Loss 360 Min | A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin | 360 minutes from the time of the ESP block |
| Venous Plasma Concentration of Ropivacaine at 20 Min | 3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block. | These samples will be repeated at 20 minutes after completion of the injection of active drug. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjib Adhikary, MD | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Milton S.Hershey Medical center | Hershey | Pennsylvania | 17033 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.5% Ropivacaine With Epinephrine | no adverse events |
| FG001 | 0.5% Ropivacaine Without Epinephrine | No advere events |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.5% Ropivacaine With Epinephrine | 20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process. |
| BG001 | 0.5% Ropivacaine Without Epinephrine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Area of Dermatomal Sensory Loss at 20 Min | A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin | Posted | Mean | Standard Deviation | cm^2 | 20 minutes from the time of the ESP block |
|
up to 48 hour following intervention
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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 | Group With EPI | No adverse Effects for the study | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sanjib Adhikary | Penn State MS Hershey College of Medicine-PennState Health | 717-531-6140 | sadhikary@pennstatehealth.psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 23, 2024 | Feb 21, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 25, 2023 | Feb 21, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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This will be a randomized,double blinded, controlled study.
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| Epinephrine | Drug | injection of 20mL epinephrine in combination with ropivacaine at the left or right T5 transverse process |
|
| Venous Plasma Concentration of Ropivacaine at 60 Min | 3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block. | These samples will be repeated at 60 minutes after completion of the injection of active drug. |
| Venous Plasma Concentration of Ropivacaine at 90 Min | 3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block. | These samples will be repeated at 90 minutes after completion of the injection of active drug. |
| Venous Plasma Concentration of Ropivacaine at 120 Min | 3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block. | These samples will be repeated at 120 after completion of the injection of active drug. |
| Venous Plasma Concentration of Ropivacaine at 240 Min | 3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block. | These samples will be repeated at 240 minutes after completion of the injection of active drug. |
| Volume of Injectate Spread Measured Using MRI at 30 Min | The subject will undergo two MRIs to determine the spread of the anesthetic. | 30 minutes from the time of the ESP block |
| Volume of Injectate Spread Measured Using MRI at 90 Min | The subject will undergo two MRIs to determine the spread of the anesthetic. | 90 minutes from the time of the ESP block |
0.5% Ropivacaine without epinephrine injected at the left or right T5 transverse process.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Area of Dermatomal Sensory Loss 60 Min | A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin | Posted | Mean | Standard Deviation | cm^2 | 60 minutes from the time of the ESP block |
|
|
|
| Primary | Area of Dermatomal Sensory Loss 120 Min | A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin | Posted | Mean | Standard Deviation | cm^2 | 120 minutes from the time of the ESP block |
|
|
|
| Primary | Area of Dermatomal Sensory Loss at 240 Min | A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin | Posted | Mean | Standard Deviation | cm^2 | 240 minutes from the time of the ESP block |
|
|
|
| Primary | Area of Dermatomal Sensory Loss 360 Min | A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin | Posted | Mean | Standard Deviation | cm^2 | 360 minutes from the time of the ESP block |
|
|
|
| Primary | Venous Plasma Concentration of Ropivacaine at 20 Min | 3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block. | Posted | Mean | Standard Deviation | ng/mL | These samples will be repeated at 20 minutes after completion of the injection of active drug. |
|
|
|
| Primary | Venous Plasma Concentration of Ropivacaine at 60 Min | 3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block. | Posted | Mean | Standard Deviation | ng/mL | These samples will be repeated at 60 minutes after completion of the injection of active drug. |
|
|
|
| Primary | Venous Plasma Concentration of Ropivacaine at 90 Min | 3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block. | Posted | Mean | Standard Deviation | ng/mL | These samples will be repeated at 90 minutes after completion of the injection of active drug. |
|
|
|
| Primary | Venous Plasma Concentration of Ropivacaine at 120 Min | 3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block. | Posted | Mean | Standard Deviation | ng/mL | These samples will be repeated at 120 after completion of the injection of active drug. |
|
|
|
| Primary | Venous Plasma Concentration of Ropivacaine at 240 Min | 3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block. | Posted | Mean | Standard Deviation | ng/mL | These samples will be repeated at 240 minutes after completion of the injection of active drug. |
|
|
|
| Primary | Volume of Injectate Spread Measured Using MRI at 30 Min | The subject will undergo two MRIs to determine the spread of the anesthetic. | Posted | Mean | Standard Deviation | mm^3 | 30 minutes from the time of the ESP block |
|
|
|
| Primary | Volume of Injectate Spread Measured Using MRI at 90 Min | The subject will undergo two MRIs to determine the spread of the anesthetic. | Posted | Mean | Standard Deviation | mm^3 | 90 minutes from the time of the ESP block |
|
|
|
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Group Without Epi | No adverse events | 0 | 6 | 0 | 6 | 0 | 6 |
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| D000588 |
| Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |