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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03284 | Registry Identifier | NCI CTRP |
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The goal of this clinical research study is to learn if there is a difference in patients' quality of recovery if they receive 1 of 2 standard kinds of pain control treatments after surgery on the liver and/or pancreas. Researchers want to learn which method helps people to recover more completely and more quickly after surgery.
The 2 kinds of pain control are intravenous (IV) pain management and epidural pain management.
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. For every participant assigned to Group 1, 3 participants will be assigned to Group 2. This means you are 3 times more likely to be assigned to Group 2 than you are to Group 1.
Group 1:
IV pain management will be given through a needle in your arm. This needle will be placed when you are either in the holding area or in the operating room. You will have this needle placed no matter if you take part in this study or not. The needle is used to give drugs and manage fluids during surgery.
After surgery, your doctor will set the limit for the highest dose of pain medication that you can receive at any time, but you will be able to use a hand-held button to adjust your drug according to the level of pain you may be having.
If your pain is not well controlled, the study staff may decide you can be switched to Group 2 if it seems to be in your best interest.
Group 2:
Epidural pain management will be given through a needle inserted into the space between the covering of your spinal cord and the cord itself. This area is full of fluid and is called the epidural region. The needle will be placed before your surgery, either in the holding area or in the operating room by the doctor that gives your anesthesia.
If your epidural does not work, the study staff may decide you can be switched to Group 1 if it seems to be in your best interest.
Both Groups:
During your surgery, you will have a catheter (sterile flexible tube) placed in an artery. This catheter will be used to provide additional fluid and blood support and to monitor you during surgery. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form.
During surgery, blood (about 1 tablespoon) will be drawn before you receive anesthesia. This blood will be drawn using one of the IV lines that you already have in place for your surgery. This blood will be tested to look for certain proteins called cytokines that may help researchers to understand how your body is responding to pain and how pain is affecting the healing process.
You will be asked to sign a separate consent form that describes the surgery and its risks in detail. The study staff will also tell you about the standard pain medications, how they will be given, and the possible risks.
After Surgery:
After your surgery, you will go to the Post-Anesthesia Care Unit (PACU) for recovery. You will have a physical exam to check your recovery. Your vital signs will also be measured. You will be asked how you are feeling. Your doctor(s) will decide whether you will go from the PACU to the intensive care unit (ICU), overnight recovery suite, or will be moved to a regular post-surgical recovery floor room, where your recovery will be watched.
On Days 1, 3, and 5 after your surgery, blood (about 1 tablespoon) will be drawn for cytokine testing. This blood will be drawn along with the other routine blood work that you will have after your surgery.
If you are in Group 2, a member of the MD Anderson Pain Service will check your epidural site every day to make sure that it is working and that there are no problems with the area around your epidural. A nurse will also check during each shift (about every 8-10 hours) to see how well you are able to move and how the epidural is affecting your feeling in the area it is supposed to be working in.
In both groups, you will be asked to rate your level of pain management on a scale of 0-10. When you first come out of surgery, this pain rating will happen about every hour. Your pain will also be rated about every hour if you are assigned to the surgical ICU. When you get to your room (overnight recovery or surgical floor), it will happen about every 4 hours. You can use your call bell to let a nurse know if your pain is intolerable between the nurses checks.
Questionnaires:
Before your surgery, you will fill out questionnaires about the pain and your quality of life. This should take about 20 minutes to complete.
From the day after surgery (Day 1) through Day 5, you will also be asked to fill out questionnaires about your recovery and any side effects and symptoms you may be having from the pain medication. This will take about 20-40 minutes.
While you are in the hospital, you will be asked to answer some questions that will measure how quickly you recover from the sedation used during your surgery. Each shift (about every 8-10 hours), a nurse will ask you questions to find out how quickly you are recovering from anesthesia.
Length of Study Participation:
The pain medication or epidural insertion will be stopped early if you are having intolerable side effects or if the medication is not working.
Your participation in the study will be over after Day 5.
This is an investigational study. IV pain management and epidural pain management are FDA approved and commercially available. Randomly assigning you to a type of pain management and comparing the treatments is being done for research purposes only.
Up to 200 patients will be enrolled in this study. All will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Pain Management | Experimental | Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes. |
|
| Epidural Pain Management | Experimental | Thoracic epidurals placed preoperatively in either holding area or in operating room. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Patient-Controlled Analgesia (IVPCA) | Procedure | Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Experience | The Area Under the Curve (AUC) pain score during the first 48 hours after surgery. Post operative pain was measured during the first 48 hours per unit acuity guidelines. Typically this was at a minimum of every four hours yielding an average number of measures during the first 48 hours. The scale is 0-480 low scores are better. | First 48 hours after surgery |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Nicolas Vauthey, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28807031 | Derived | Cata JP, Velasquez JF, Ramirez MF, Vauthey JN, Gottumukkala V, Conrad C, Kim BJ, Aloia T. Inflammation and pro-resolution inflammation after hepatobiliary surgery. World J Surg Oncol. 2017 Aug 10;15(1):152. doi: 10.1186/s12957-017-1220-6. | |
| 28746153 | Derived | Aloia TA, Kim BJ, Segraves-Chun YS, Cata JP, Truty MJ, Shi Q, Holmes A, Soliz JM, Popat KU, Rahlfs TF, Lee JE, Wang XS, Morris JS, Gottumukkala VNR, Vauthey JN. A Randomized Controlled Trial of Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient-controlled Analgesia After Major Hepatopancreatobiliary Surgery. Ann Surg. 2017 Sep;266(3):545-554. doi: 10.1097/SLA.0000000000002386. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Among the 178 eligible patients, 38 patients were excluded due to withdrawal of consent, development of exclusion criteria and/or the finding of unresectable disease at surgery. The study concluded with 140 patients eligible for analysis, with 106 patients allocated to the TEA group and 34 patients allocated to the IV-PCA group.
During the study period, 178 screened patients were initially eligible for inclusion to the randomized controlled trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | TEA (Thoracic Epidural Analgesia) | Thoracic Epidural Analgesia-TEA Thoracic epidurals placed preoperatively in either holding area or in operating room. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes. Thoracic Epidural Analgesia (TEA): Thoracic epidurals (needle inserted into the space between the covering of spinal cord and the cord itself) placed preoperatively in either the holding area or in the operating room. Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes. Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Nov 12, 2015 |
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| Thoracic Epidural Analgesia (TEA) | Procedure | Thoracic epidurals (needle inserted into the space between the covering of spinal cord and the cord itself) placed preoperatively in either the holding area or in the operating room. |
|
| Questionnaires | Behavioral | Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes. |
|
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| Pain Assessment | Behavioral | Hourly post surgery rating level of pain on a scale of 0-10. |
|
| FG001 | IV-PCA (Intravenous Patient-controlled Analgesia) | Intravenous Patient-controlled Analgesia IV-PCA: Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes. Intravenous Patient-Controlled Analgesia (IVPCA): Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes. Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | TEA (Thoracic Epidural Analgesia) | Thoracic Epidural Analgesia-TEA Thoracic epidurals placed preoperatively in either holding area or in operating room. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes. Thoracic Epidural Analgesia (TEA): Thoracic epidurals (needle inserted into the space between the covering of spinal cord and the cord itself) placed preoperatively in either the holding area or in the operating room. Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes. Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10. |
| BG001 | IV-PCA (Intravenous Patient-controlled Analgesia) | Intravenous Patient-controlled Analgesia IV-PCA: Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes. Intravenous Patient-Controlled Analgesia (IVPCA): Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes. Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Major hepatectomy | 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 | Postoperative Pain Experience | The Area Under the Curve (AUC) pain score during the first 48 hours after surgery. Post operative pain was measured during the first 48 hours per unit acuity guidelines. Typically this was at a minimum of every four hours yielding an average number of measures during the first 48 hours. The scale is 0-480 low scores are better. | Posted | Median | Inter-Quartile Range | score on a scale* hour | First 48 hours after surgery |
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Patients were assessed during their inpatient hospitalization average and range of length of stay for each arm is provided in the data table.
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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 | TEA (Thoracic Epidural Analgesia) | Thoracic Epidural Analgesia-TEA Thoracic epidurals placed preoperatively in either holding area or in operating room. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes. Thoracic Epidural Analgesia (TEA): Thoracic epidurals (needle inserted into the space between the covering of spinal cord and the cord itself) placed preoperatively in either the holding area or in the operating room. Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes. Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10. | 0 | 106 | 21 | 106 | 0 | 106 |
| EG001 | IV-PCA (Intravenous Patient-controlled Analgesia) | Intravenous Patient-controlled Analgesia IV-PCA: Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes. Intravenous Patient-Controlled Analgesia (IVPCA): Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. Questionnaires: Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes. Pain Assessment: Hourly post surgery rating level of pain on a scale of 0-10. | 0 | 34 | 3 | 34 | 0 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Analgesia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ileus | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jean-Nicolas Vauthey,MD/Professor, Surgical Oncology | UT MD Anderson Cancer Center | 713- 792-2022 | jvauthey@mdanderson.org |
| Jan 23, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016058 | Analgesia, Patient-Controlled |
| D013662 | Tea |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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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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