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Research suggests that the type of anesthesia used for surgery may affect intraoperative stress hormone levels. There is also data to support that an increased level of stress hormones leads to increased pain after surgery. The primary aim of this study is to determine the effect of anesthesia type on long term pain after hernia surgery. In this study, patients undergoing inguinal hernia repair will be randomized to an anesthetic group, either Total Intravenous Anesthesia (TIVA) maintained with propofol or Balanced Inhaled Anesthesia (BIA) maintained with sevoflurane. This will allow us to look at any differences in short and long-term pain after hernia repair depending on type of anesthesia received.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIA | Active Comparator | Balanced Inhalational Anesthesia (consisting of a sevoflurane inhaled anesthestic only) |
|
| TIVA-K | Active Comparator | Total intravenous anesthetic with ketamine |
|
| TIVA-R | Active Comparator | Total intravenous anesthetic with remifentanil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug |
|
| |
| Sevoflurane |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score, Chronic | Pain as measured by the Intensity Score of the Pain Quality Assessment Scale (PQAS) at each of the time points after surgery. The scale goes from 0 (no pain) to 10 (the most intense pain sensation imaginable). Higher scores mean worse pain. | 1 month, 3 months, 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score, Acute | Acute Pain on Day 1, as measured by the Pain Quality Assessment Scale (PQAS). The scale goes from 0 (no pain) to 10 (the most intense pain sensation imaginable). Higher scores means worse pain. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | BALANCED INHALATIONAL | Balanced Inhalational Anesthesia (consisting of a sevoflurane inhaled anesthestic only) Sevoflurane Remifentanil |
| FG001 | TIVA-K | Total intravenous anesthetic with ketamine Propofol Ketamine |
| FG002 | TIVA-R | Total intravenous anesthetic with remifentanil Propofol Remifentanil |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BALANCED INHALATIONAL | Balanced Inhalational Anesthesia (consisting of a sevoflurane inhaled anesthestic only) Sevoflurane Remifentanil |
| BG001 | TIVA-K | Total intravenous anesthetic with ketamine Propofol Ketamine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Pain Score, Chronic | Pain as measured by the Intensity Score of the Pain Quality Assessment Scale (PQAS) at each of the time points after surgery. The scale goes from 0 (no pain) to 10 (the most intense pain sensation imaginable). Higher scores mean worse pain. | Only 10 subjects were enrolled, and the numbers represented a typical distribution of Inhalational to TIVA use. Because of the low subject numbers, statistical differences between the techniques were not sought. | Posted | Mean | Standard Deviation | score on a scale | 1 month, 3 months, 6 months, 12 months |
|
1 year
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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 | BALANCED INHALATIONAL | Balanced Inhalational Anesthesia (consisting of a sevoflurane inhaled anesthestic only) Sevoflurane Remifentanil |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Ibinson, MD, PhD | VA Pittsburgh Healthcare System | 412-360-1484 | james.ibinson@va.gov |
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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 | May 22, 2017 | May 4, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 22, 2017 | May 4, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D059350 | Chronic Pain |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077149 | Sevoflurane |
| D000077208 | Remifentanil |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
|
|
| Remifentanil | Drug |
|
|
| Ketamine | Drug |
|
|
| BG002 | TIVA-R | Total intravenous anesthetic with remifentanil Propofol Remifentanil |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pain level in PACU | Pain as measured by the Intensity Score of the Pain Quality Assessment Scale (PQAS) in the Post Anesthesia Recovery Unit (PACU) immediately after surgery. The scale goes from 0 (no pain) to 10 (the most intense pain sensation imaginable). | Mean | Standard Deviation | Pain score (0-10) |
|
Total intravenous anesthetic with ketamine Propofol Ketamine |
| OG002 | TIVA-R | Total intravenous anesthetic with remifentanil Propofol Remifentanil |
|
|
| Secondary | Pain Score, Acute | Acute Pain on Day 1, as measured by the Pain Quality Assessment Scale (PQAS). The scale goes from 0 (no pain) to 10 (the most intense pain sensation imaginable). Higher scores means worse pain. | Posted | Mean | Standard Deviation | score on a scale | 1 day |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | TIVA-K | Total intravenous anesthetic with ketamine Propofol Ketamine | 0 | 2 | 0 | 6 | 0 | 2 |
| EG002 | TIVA-R | Total intravenous anesthetic with remifentanil Propofol Remifentanil | 0 | 2 | 0 | 6 | 0 | 2 |
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| D020763 | Pathological Conditions, Anatomical |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |