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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00395 | Registry Identifier | NCI Trial ID | |
| 2014-1458 | Other Identifier | HS-IRB | |
| A532820 | Other Identifier | UW Madison | |
| SMPH\OBSTET & GYNEC\GYNEC ONC | Other Identifier | UW Madison | |
| Protocol Version 11/14/2016 | Other Identifier | UW Madison |
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This randomized clinical trial studies epidural anesthesia within an enhanced recovery pathway (ERP) in reducing pain in patients undergoing gynecologic surgery. An epidural analgesia (pain relief) is a small tube placed in the lower back that numbs the nerves and stops the feeling of pain. It stays in place for several days after surgery and may be helpful for pain control in patients with gynecologic cancer after surgery. ERP is a set of specific steps used before, during, and after surgery by health care providers to care for patients after surgery. ERPs include patient education, not using laxatives before surgery, increasing activity after surgery, and scheduled use of medications for pain and nausea. Giving epidural anesthesia as part of an ERP may improve pain control in patients undergoing gynecologic surgery.
PRIMARY OBJECTIVES:
I. Mean postoperative pain score for the first 24 hours post-operatively, (measured by the Numeric Rating Scale [NRS], which rates pain on a 1-10 scale, collected routinely on the post-operative floor) will be compared between the epidural and no-epidural groups.
SECONDARY OBJECTIVES:
I. Total opioid use measured in oral morphine equivalents for the first two days post-surgery.
II. Length of hospital stay (measured in hours from admission to time of discharge order placement).
III. Post-operative antiemetic use and number of recorded episodes of emesis. IV. Return of bowel function (measured in hours from completion of surgery to passage of flatus).
V. Subject satisfaction at the 4 week post-operative visit (as measured by two pain satisfaction questions taken from the Hospital Consumer Assessment of Healthcare Providers and Systems [HCAHPS] survey).
VI. Post-operative complications (urinary tract infections [UTIs], thromboembolic events, pneumonia, blood transfusion, myocardial infarction, falls).
VII. Readmission rate. VIII. Epidural discontinuation rates prior to planned removal (in epidural group only).
IX. Stress and inflammation serum and saliva markers at baseline and the first day after surgery, as well as at their postoperative visit.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo epidural placement in the First Day Surgery pre-operative area or similar areas suitable for insertion of epidural catheters. In the post-operative anesthesia care unit, patients may receive medication via the epidural on an as needed basis, as determined by the anesthesia team. Dosing and rate of standardized medication will be managed by the anesthesia team until the epidural is removed. Patients complete the ERP comprising increased activity, dietary restrictions, fluid balance, as well as anti-nausea, anti-inflammatory and pain medications at specific times. Patients will have access to additional pain medications as needed to control their pain.
ARM II: Patients complete the ERP comprising increased activity, dietary restrictions, fluid balance, as well as anti-nausea, anti-inflammatory and pain medications at specific times. Patients will have access to additional pain medications as needed to control their pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (epidural placement, ERP) | Experimental | Patients undergo epidural placement in the First Day Surgery pre-operative area or similar areas suitable for insertion of epidural catheters. In the post-operative anesthesia care unit, patients may receive medication via the epidural on an as needed basis, as determined by the anesthesia team. Dosing and rate of standardized medication will be managed by the anesthesia team until the epidural is removed. Patients complete the ERP comprising increased activity, dietary restrictions, fluid balance, as well as anti-nausea, anti-inflammatory and pain medications at specific times. Patients will have access to additional pain medications as needed to control their pain. |
|
| Arm II (ERP) | Active Comparator | Patients complete the ERP comprising increased activity, dietary restrictions, fluid balance, as well as anti-nausea, anti-inflammatory and pain medications at specific times. Patients will have access to additional pain medications as needed to control their pain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural analgesia | Drug | Receive epidural placement. Standard epidural medications and dosage are as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative Pain Scores, as Measured by the Pain Numeric Rating Scale (NRS) | Relative pain scores between the epidural and non-epidural group will be analyzed by calculating a two-sided 95% confidence interval on the difference in mean scores between the two groups and concluding non-inferiority if this lies entirely below 2 points (mean non-epidural pain score proven, within a 95% confidence limit, to be at most 2 points worse than mean pain score in the epidural group). NRS rates pain on a 1-10 scale, with 1 being no pain, and 10 being the worst pain imaginable. | Up to 24 hours post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Average Daily Pain Score as Measured by Pain NRS Scores | Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. | Up to 2 days following surgery |
| Difference in IL-2 Levels Between Pre-operative and Post-operative Values |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Barroilhet | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53792 | United States |
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| Label | URL |
|---|---|
| University of Wisconsin Carbone Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Epidural Placement, ERP) | Patients undergo epidural placement in the First Day Surgery pre-operative area or similar areas suitable for insertion of epidural catheters. In the post-operative anesthesia care unit, patients may receive medication via the epidural on an as needed basis, as determined by the anesthesia team. Dosing and rate of standardized medication will be managed by the anesthesia team until the epidural is removed. Patients complete the ERP comprising increased activity, dietary restrictions, fluid balance, as well as anti-nausea, anti-inflammatory and pain medications at specific times. Patients will have access to additional pain medications as needed to control their pain. Epidural analgesia: Receive epidural placement. Standard epidural medications and dosage are as follows:
Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP |
| 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 14, 2016 |
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|
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| Intraoperative Complication Management and Prevention | Other | Undergo ERP |
|
|
| Pain Therapy | Procedure | Undergo ERP |
|
|
Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. |
| Baseline to up to day 1 post-surgery |
| Epidural Discontinuation Rates Prior to Planned Removal (in Epidural Group Only) | Will be tabulated and presented for each group (where applicable). | Up to post-operative day 14 |
| Length of Hospital Stay (Hours) | Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. | From admission to time of discharge order placement |
| Length of Time Until Return of Bowel Function | Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. | From completion of surgery to passage of flatus (report in days) |
| Number of Recorded Episodes of Emesis | Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. | Up to 5 days post-surgery |
| Patient Satisfaction Scores Related to Pain Metrics, as Measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey | Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. Scores range from 1 to 4, with higher scores indicating higher satisfaction. | At 4 weeks post-operative visit |
| Post-operative Antiemetic Use (Measured in mg of Ondanestron Used in the First 24 Hours After Surgery) | Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. | Up to 4 weeks post-surgery |
| Post-operative Complications (UTIs, Thromboembolic Events, Pneumonia, Blood Transfusion, Myocardial Infarction, Falls) | # of events in each group will be reported | Up to 6 weeks post-surgery |
| Readmission Rate | Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. | Up to 6 weeks post-surgery |
| Total Opioid Use Measured in Oral Morphine Equivalents (mg) | Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. | Up to first 2 days post-surgery |
| FG001 | Arm II (ERP) | Patients complete the ERP comprising increased activity, dietary restrictions, fluid balance, as well as anti-nausea, anti-inflammatory and pain medications at specific times. Patients will have access to additional pain medications as needed to control their pain. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Epidural Placement, ERP) | Patients undergo epidural placement in the First Day Surgery pre-operative area or similar areas suitable for insertion of epidural catheters. In the post-operative anesthesia care unit, patients may receive medication via the epidural on an as needed basis, as determined by the anesthesia team. Dosing and rate of standardized medication will be managed by the anesthesia team until the epidural is removed. Patients complete the ERP comprising increased activity, dietary restrictions, fluid balance, as well as anti-nausea, anti-inflammatory and pain medications at specific times. Patients will have access to additional pain medications as needed to control their pain. Epidural analgesia: Receive epidural placement. Standard epidural medications and dosage are as follows:
Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP |
| BG001 | Arm II (ERP) | Patients complete the ERP comprising increased activity, dietary restrictions, fluid balance, as well as anti-nausea, anti-inflammatory and pain medications at specific times. Patients will have access to additional pain medications as needed to control their pain. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP |
| BG002 | 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, Customized | Count of Participants | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||
| Region of Enrollment | Number | 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 | Relative Pain Scores, as Measured by the Pain Numeric Rating Scale (NRS) | Relative pain scores between the epidural and non-epidural group will be analyzed by calculating a two-sided 95% confidence interval on the difference in mean scores between the two groups and concluding non-inferiority if this lies entirely below 2 points (mean non-epidural pain score proven, within a 95% confidence limit, to be at most 2 points worse than mean pain score in the epidural group). NRS rates pain on a 1-10 scale, with 1 being no pain, and 10 being the worst pain imaginable. | Modified intent to treat analysis | Posted | Mean | 95% Confidence Interval | score on a scale | Up to 24 hours post-surgery |
|
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| ||||||||||||||||||||||||||||
| Secondary | Average Daily Pain Score as Measured by Pain NRS Scores | Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. | modified intent to treat | Posted | Mean | 95% Confidence Interval | score on a scale | Up to 2 days following surgery |
| ||||||||||||||||||||||||||||||
| Secondary | Difference in IL-2 Levels Between Pre-operative and Post-operative Values | Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. | Modified intent to treat analysis | Posted | Mean | 95% Confidence Interval | nmol/L | Baseline to up to day 1 post-surgery |
| ||||||||||||||||||||||||||||||
| Secondary | Epidural Discontinuation Rates Prior to Planned Removal (in Epidural Group Only) | Will be tabulated and presented for each group (where applicable). | Posted | Count of Participants | Participants | Up to post-operative day 14 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Length of Hospital Stay (Hours) | Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. | Modified intent to treat | Posted | Mean | 95% Confidence Interval | hours | From admission to time of discharge order placement |
| ||||||||||||||||||||||||||||||
| Secondary | Length of Time Until Return of Bowel Function | Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. | modified intent to treat analysis | Posted | Mean | 95% Confidence Interval | days | From completion of surgery to passage of flatus (report in days) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Recorded Episodes of Emesis | Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. | modified intent to treat analysis | Posted | Mean | 95% Confidence Interval | number of episodes | Up to 5 days post-surgery |
| ||||||||||||||||||||||||||||||
| Secondary | Patient Satisfaction Scores Related to Pain Metrics, as Measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey | Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. Scores range from 1 to 4, with higher scores indicating higher satisfaction. | Modified intent to treat | Posted | Mean | 95% Confidence Interval | score on a scale of 1-4 | At 4 weeks post-operative visit |
| ||||||||||||||||||||||||||||||
| Secondary | Post-operative Antiemetic Use (Measured in mg of Ondanestron Used in the First 24 Hours After Surgery) | Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. | modified intent to treat analysis | Posted | Mean | 95% Confidence Interval | mg | Up to 4 weeks post-surgery |
| ||||||||||||||||||||||||||||||
| Secondary | Post-operative Complications (UTIs, Thromboembolic Events, Pneumonia, Blood Transfusion, Myocardial Infarction, Falls) | # of events in each group will be reported | modified intent to treat | Posted | Count of Participants | Participants | Up to 6 weeks post-surgery |
| |||||||||||||||||||||||||||||||
| Secondary | Readmission Rate | Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. | modified intent to treat | Posted | Count of Participants | Participants | Up to 6 weeks post-surgery |
| |||||||||||||||||||||||||||||||
| Secondary | Total Opioid Use Measured in Oral Morphine Equivalents (mg) | Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. | Modified intent to treat analysis | Posted | Mean | 95% Confidence Interval | mg | Up to first 2 days post-surgery |
|
Up to 6 weeks
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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 | Arm I (Epidural Placement, ERP) | Patients undergo epidural placement in the First Day Surgery pre-operative area or similar areas suitable for insertion of epidural catheters. In the post-operative anesthesia care unit, patients may receive medication via the epidural on an as needed basis, as determined by the anesthesia team. Dosing and rate of standardized medication will be managed by the anesthesia team until the epidural is removed. Patients complete the ERP comprising increased activity, dietary restrictions, fluid balance, as well as anti-nausea, anti-inflammatory and pain medications at specific times. Patients will have access to additional pain medications as needed to control their pain. Epidural analgesia: Receive epidural placement. Standard epidural medications and dosage are as follows:
Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP | 0 | 52 | 1 | 52 | 35 | 52 |
| EG001 | Arm II (ERP) | Patients complete the ERP comprising increased activity, dietary restrictions, fluid balance, as well as anti-nausea, anti-inflammatory and pain medications at specific times. Patients will have access to additional pain medications as needed to control their pain. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP | 0 | 52 | 1 | 52 | 28 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| wound infection, fascial dehiscence | Infections and infestations | CTCAE v4.0 | Systematic Assessment | required second surgery |
|
| pneumonia | Infections and infestations | CTCAE v4.0 | Systematic Assessment | requiring IV antibiotics and hospital readmission |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anemia | Blood and lymphatic system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| vascular thrombolic event | Blood and lymphatic system disorders | CTCAE v4.0 | Systematic Assessment |
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Cytokine samples were not able to be interpreted due to huge variances, and they are being run again on a different flow cytometry machine.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cancer Connect | University of Wisconsin Carbone Cancer Center | 800-622-8922 | clinicaltrials@cancer.wisc.edu |
| Jun 19, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007431 | Intraoperative Complications |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D015360 | Analgesia, Epidural |
| D000767 | Anesthesia, Epidural |
| D004091 | Hydromorphone |
| D000077212 | Ropivacaine |
| D000698 | Analgesia |
| D059408 | Pain Management |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D013812 | Therapeutics |
| D019468 | Disease Management |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Title | Measurements |
|---|---|
|
| 40-49 years |
|
| 50-59 years |
|
| 60-69 years |
|
| 70-79 years |
|
| 80-89 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Patients complete the ERP comprising increased activity, dietary restrictions, fluid balance, as well as anti-nausea, anti-inflammatory and pain medications at specific times. Patients will have access to additional pain medications as needed to control their pain. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP |
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|
Patients complete the ERP comprising increased activity, dietary restrictions, fluid balance, as well as anti-nausea, anti-inflammatory and pain medications at specific times. Patients will have access to additional pain medications as needed to control their pain. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP |
|
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|
|
Patients complete the ERP comprising increased activity, dietary restrictions, fluid balance, as well as anti-nausea, anti-inflammatory and pain medications at specific times. Patients will have access to additional pain medications as needed to control their pain. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP |
|
|
Patients complete the ERP comprising increased activity, dietary restrictions, fluid balance, as well as anti-nausea, anti-inflammatory and pain medications at specific times. Patients will have access to additional pain medications as needed to control their pain. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP |
|
|
Patients complete the ERP comprising increased activity, dietary restrictions, fluid balance, as well as anti-nausea, anti-inflammatory and pain medications at specific times. Patients will have access to additional pain medications as needed to control their pain. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP |
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| OG001 | Arm II (ERP) | Patients complete the ERP comprising increased activity, dietary restrictions, fluid balance, as well as anti-nausea, anti-inflammatory and pain medications at specific times. Patients will have access to additional pain medications as needed to control their pain. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP |
|
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| Arm II (ERP) |
Patients complete the ERP comprising increased activity, dietary restrictions, fluid balance, as well as anti-nausea, anti-inflammatory and pain medications at specific times. Patients will have access to additional pain medications as needed to control their pain. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP |
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Patients complete the ERP comprising increased activity, dietary restrictions, fluid balance, as well as anti-nausea, anti-inflammatory and pain medications at specific times. Patients will have access to additional pain medications as needed to control their pain.
Intraoperative Complication Management and Prevention: Undergo ERP
Pain Therapy: Undergo ERP
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|
Patients complete the ERP comprising increased activity, dietary restrictions, fluid balance, as well as anti-nausea, anti-inflammatory and pain medications at specific times. Patients will have access to additional pain medications as needed to control their pain. Intraoperative Complication Management and Prevention: Undergo ERP Pain Therapy: Undergo ERP |
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