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Low accrual
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The purpose of this study is to compare intra and postoperative pain control between Paravertebral block vs no block in open pancreaticoduodenectomy. Length of stay, and complications will also be recorded. For this study the investigator plans to randomize to obtain objective data for clinical decisions and improve patient outcomes. Following surgery patients in both groups, data will be collected from the first 48 hours after surgery and at discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paravertebral Block Pre Procedure | Active Comparator | Subject will receive a preoperative paravertebral block only |
|
| No Paravertebral Block | No Intervention | Subject will receive no paravertebral block. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | Paravertebral at the T7-10 levels bilaterally with 5 cc of 0.5% ropivacaine at each level |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Post-operative Pain Score | The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain. The average score across the 11 questions was calculated for each subject using the minimum and maximum values reported for each subject across the 11 questions. | First 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay | Total number of days subjects were admitted to the hospital following surgery | Approximately 4-6 days post surgery |
| Number of Subjects With a Bowel Obstruction | Number of subjects to experience a bowl obstruction following surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Stauffer, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Paravertebral Block Pre Procedure | Subject will receive a preoperative paravertebral block only Ropivacaine: Paravertebral at the T7-10 levels bilaterally with 5 cc of 0.5% ropivacaine at each level |
| FG001 | No Paravertebral Block | Subject will receive no paravertebral block. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Paravertebral Block Pre Procedure | Subject will receive a preoperative paravertebral block only Ropivacaine: Paravertebral at the T7-10 levels bilaterally with 5 cc of 0.5% ropivacaine at each level |
| BG001 | No Paravertebral Block |
| 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 | Mean Post-operative Pain Score | The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain. The average score across the 11 questions was calculated for each subject using the minimum and maximum values reported for each subject across the 11 questions. | Posted | Mean | Full Range | score on a scale | First 48 hours after surgery |
|
Adverse events were collected from the time of surgery until time of discharge, approximately 6 days.
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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 | Paravertebral Block Pre Procedure | Subject will receive a preoperative paravertebral block only Ropivacaine: Paravertebral at the T7-10 levels bilaterally with 5 cc of 0.5% ropivacaine at each level |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| lleus | Gastrointestinal disorders | Systematic Assessment |
The study was terminated due to low accrual.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Stauffer | Mayo Clinic | 904-953-2000 | stauffer.john@mayo.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 | Jan 17, 2023 | Nov 20, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Approximately 2-4 days |
Subject will receive no paravertebral block.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Subject will receive no paravertebral block.
|
|
| Secondary | Hospital Length of Stay | Total number of days subjects were admitted to the hospital following surgery | Block patient LOS =5. No block patient LOS =6. | Posted | Number | days | Approximately 4-6 days post surgery |
|
|
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| Secondary | Number of Subjects With a Bowel Obstruction | Number of subjects to experience a bowl obstruction following surgery | No patients had a bowel obstruction. | Posted | Count of Participants | Participants | Approximately 2-4 days |
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| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | No Paravertebral Block | Subject will receive no paravertebral block. | 0 | 1 | 0 | 1 | 1 | 1 |
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| D000588 |
| Amines |